method for preparing a sterilized liquid or semi-solid acidic enteral composition and using steam to

专利摘要:
WHEY PROTEIN COMPOSITION WITH A REDUCED ASTRINGENCE. The invention relates to a sterilized acidic liquid or semi-solid enteral composition comprising, per 100 ml, 9 to 20 g of unhydrolyzed globular proteins, fat and at least 100 mg of divalent metal cations and having a pH ranging between 3 and 5 The invention further relates to a method for preparing a composition according to the invention comprising a step in . 10 that at least unhydrolyzed globular proteins are subjected to a direct steam injection (DSl) at specific retention values, such as a retention temperature of 100 to 140°C, during a retention time of about 0.5 to 10 seconds, followed by a homogenization step and a sterilization step. The composition according to the invention has a reduced astringency and can be used for medical purposes, such as for stimulating muscle protein synthesis in a mammal, in particular for treating sarcopenia, and for specific groups of people, such as the elderly and sportsmen.
公开号:BR112013017628B1
申请号:R112013017628-8
申请日:2011-12-16
公开日:2021-05-25
发明作者:Matthijs Leonard Joseph Van Der Zande；Gerrit Jan Waterink
申请人:N.V. Nutricia；
IPC主号:

专利说明:

FIELD OF THE INVENTION
[001] The present invention relates to a sterilized liquid or acidic semi-solid enteral composition comprising a large amount of non-hydrolyzed globular proteins such as whey, fat and a large amount of divalent metal cations such as calcium and magnesium and having a reduced astringency, methods for preparing such a composition and using such a composition in the manufacture of a nutritional food to be used as a complete food or as a nutritional supplement. The present invention also relates to a nutritional composition useful for medical purposes, such as for stimulating muscle protein synthesis in a mammal, in particular for treating sarcopenia and for specific groups of people, such as the elderly and sportsmen. BACKGROUND OF THE INVENTION
[002] Some individuals need nutrition, either as a supplement or as a complete nutrition, in the smallest volume of fluid, which is still effective for its intended purpose.
[003] These individuals can be patients or people suffering from end-stage AIDS, cancer or cancer treatment, serious lung diseases such as COPD (Chronic Obstructive Pulmonary Disease), tuberculosis and other infectious diseases or people who have undergone surgery or severe trauma, such as burns. Also, people who suffer from throat or mouth disorders, such as esophageal cancer or stomatitis, and people who have swallowing problems, such as people with dysphagia, who require special low-volume liquid nutrition. Also, people who suffer from decreased appetite or loss of taste will benefit from low volume food, preferably liquid.
[004] These individuals can also be elderly people, in particular elderly people with frailty and elderly people at risk of acquiring frailty. In this regard, although an elderly person's energy needs can be reduced, their ability to consume products can also be diminished. For example, they may have difficulty consuming a product, for example, because of difficulty in swallowing or because too much product needs to be consumed to satisfy their daily nutrient intake. Consequently, compliance is not optimal and intake is often suboptimal, leading to suboptimal nutrition and, ultimately, malnutrition.
[005] These individuals can also be sportsmen (men or women), since a sportsman can also benefit from a concentrated protein drink.
[006] Due to a prerequisite of at least six months shelf life in general, preferably at least 12 months, whey protein compositions need to undergo some type of sterilization treatment in order to reduce or remove the range of possible pathogens, eg spores, bacteria and other microorganisms, which cause deterioration of the protein composition, preferably using heat (sterilization, pasteurization), radiation (UV treatment) or filtration methods (ultrafiltration , diafiltration, nanofiltration). Preferred sterilization treatments include heat treatments at high temperatures for a short period, such as the use of a UHT (Ultra High Temperature) treatment. However, when whey proteins are subjected to heat, the whey proteins are rapidly denatured, whereby the globular structure of the whey protein curls up and, at a pH between 3 and 7, can form clumps and macrostructures. , which are visible as a haze or turbidity. Eventually the agglomerates will settle and the nutritional composition will be unacceptable for consumption. The use of acid whey (ie whey with a pH < 7, preferably with a pH between 3 and 5) obtained from an acid whey process (also known as "whey" ) or by acidifying whey (acidified whey) obtained from acidifying whey or sweet whey, for example, by adding an acid, such as phosphoric acid, is preferable because whey acid is less prone to pathogens and therefore only requires a mild heat sterilization treatment, such as pasteurization or UHT treatment. Furthermore, an acid whey protein composition has a more preferred taste and aroma than a neutral whey protein composition (pH of about 7).
[007] The aforementioned groups of individuals may be sensitive to the consistency of food and the organoleptic properties of an acidic composition comprising a high amount of unhydrolyzed globular proteins, such as whey proteins such as, for example, viscosity, taste, aroma , color and mouthfeel, in particular astringency.
[008] Acid whey protein solutions cause an astringent taste sensation in the mouth, regardless of whey source (WPI, WPC and others). Although the exact mechanism of astringency by whey proteins is not known, it has been published (Astringency of Bovine Milk Whey Protein, H. Sano, T. Egashira, Y. Kinekawa and N. Kitabatake, J. Dairy Sci. 88, July 2005: 2312-2317) that most whey proteins are precipitated in the mouth at a pH of about 5. When an acidic WPI solution (pH 3.5) is placed in the oral cavity, the acidic solution is mixed with saliva (pH about 7), causing the pH of the whey protein solution to increase but remain at a pH < 5. At this pH (close to the isoelectric point of the whey protein), the protein of whey is precipitated in the mouth. This precipitate is formed in the oral cavity and induces an astringency in a manner similar to the complex precipitation formed by polyphenolic compounds and salivary proteins such as can be found in wine, green tea and some fruits.
[009] Furthermore, it has been established that astringency increases with increasing whey concentrations and shows a maximum at a pH of 3. This causes astringency to become a real taste problem in nutritional compositions that have a high amount of whey and an acidic pH. The problem is particularly evident at an acidic pH of around 3, in particular at a pH between 3 and 5.
[0010] It is further considered that the presence of divalent metal cations such as magnesium and calcium - both important nutrients - may contribute to astringency. Furthermore, it is considered that the presence of divalent metal cations, in particular calcium, may adversely affect the solubility of whey protein and/or adversely affect the viscosity of a liquid comprising whey protein and/or affect shelf life adversely, in particular in the case where the whey protein concentration is relatively high or the liquid is heat treated.
[0011] In view of the expected problems regarding organoleptic properties, in particular astringency, protein solubility and/or viscosity control, those skilled in the art therefore do not consider providing a sterilized acidic semi-solid liquid enteral composition comprising a high amount of unhydrolyzed globular proteins, such as whey, fat and a high amount of divalent metal cations, as it would not be expected to be able to provide such a product with satisfactory properties for the consumer.
[0012] Therefore, a problem underlying the present invention is how to provide a sterilized acidic semi-solid liquid enteral composition comprising a high amount of unhydrolyzed globular proteins such as whey, fat and a high amount of divalent metal cations such as as calcium and magnesium and having satisfactory properties, in particular satisfactory shelf life and satisfactory organoleptic properties, to impart nutrition, either as a supplement or as a complete nutrition.
[0013] In particular, a problem underlying the invention is how to provide a product with a satisfactory shelf life and no or low astringency and/or no or low grittiness.
[0014] More in particular, a problem underlying the invention is how to provide a sterilized acidic semi-solid liquid enteral composition comprising a high content of unhydrolyzed globular proteins such as whey, fat and a high amount of divalent metal cations in a relatively small fluid volume, while sustaining nutrition and well-being in the different groups of individuals mentioned above.
[0015] The inventors have now found that such a problem is solved by preparing an acidic semi-solid liquid enteral composition sterilized in a specific manner, i.e. using a method for producing said composition, which comprises at least one step of direct injection of steam (Direct Steam Injection - DSI), so the DSI is not used for sterilization purposes. Thus, the present invention makes it possible to provide the specific composition, as defined herein below and in the claims, as an industrially applicable composition. BACKGROUND TECHNIQUE FOR THE INVENTION
[0016] There are great technical difficulties in the production of a sterilized acidic semi-solid liquid enteral composition comprising a high amount of unhydrolyzed globular proteins such as whey, fat and a high amount of divalent metal cations such as calcium and magnesium and having a reduced astringency.
[0017] EP 1 894 477 A1 (Nestec SA, 03/05/2008) describes the formation of a coated denatured supramolecular protein core structure (a liposome-like structure) comprising a whey protein aggregate and a lipid bilayer (sulfated butyl oleate) for reducing the astringency of supramolecular protein structures (in particular micelles).
[0018] JP 57189657 A (Mitsubishi, 11/22/1982) describes an astringency-free soy milk beverage by adding a fatty acid ester to soy milk, homogenizing the mixture and heat treatment at > 70 °C.
[0019] WO 2009/112036 (Arla Foods, 17/09/2009) describes whey protein drinks with a reduced astringency comprising 0.5-15% by weight of whey and a protective agent, in particular, a monoglyceride.
[0020] WO 2007/108827 (Novartis, 27/09/2007) describes the use of DSI for reducing the viscosity of a milk protein isolate composition.
[0021] Nutritional compositions with a high amount of unhydrolyzed globular protein, in particular whey, have been described, for example, in WO 2009/113858 (NV Nutricia, 17/09/2009) and in WO 2009/072884 (Nutricia, 06/11/2009).
[0022] WO 2010/043415 (Nestec SA, 22/04/2010) describes a shelf-stable acid whey composition comprising 10.67 g/100 g WPI and 5.64 g/100 g WPH ( hydrolyzate) - Example 3. DSI is used as a sterilization treatment (120°C/11sec, 80°C fast). The inclusion of divalent metal cations is not mentioned. The presence of a whey hydrolyzate gives the resulting composition a bad taste. SUMMARY OF THE INVENTION
[0023] The inventors have now established that a sterilized acidic semi-solid liquid enteral composition comprising a high content of unhydrolyzed globular proteins such as whey, fat and a large amount of divalent metal cations such as calcium and magnesium and having properties Satisfactory organoleptics, in particular a reduced astringency, is obtained through a process which includes a step in which a composition is subjected to a step of direct steam injection (DSI) at specific retention values and a specific combination with other process steps, in particular after the step of homogenization of said composition and before a final sterilization treatment (meaning sterilization or pasteurization). In a preferred embodiment, the invention provides a sterilized acidic liquid or semi-solid enteral nutritional composition comprising, per 100 ml of the composition, from 9 to 20 g of unhydrolyzed globular protein, fat and at least 100 mg of divalent metal cations, having a pH ranging between 3 and 5, preferably ranging between about 3.7 and about 4.3, more preferably a pH of about 3.8, about 3.9, about 4.0, about 4, 1 or about 4.2, more preferably a pH of about 4.0. In an advantageous modality, such composition is highly appreciated because of its low astringency or lack of astringency and/or because of its low grit or lack of grit.
[0024] In another embodiment, the invention provides a sterilized liquid or acidic semi-solid enteral nutritional composition according to the invention which further comprises one or more of carbohydrates and dietary fibers. Such a composition is useful and applicable for medical purposes such as sarcopenia and for specific groups of people such as the elderly and sportsmen.
[0025] In another embodiment, the invention provides the use of said sterilized liquid or acidic semi-solid enteral nutritional composition according to the invention for the manufacture of a nutritional composition to provide nutrition to a person in need thereof.
[0026] In another embodiment, the invention provides a method for preparing a sterilized acidic semi-solid liquid enteral composition comprising, per 100 ml of said composition, 9 to 20 g of unhydrolyzed globular proteins, fat and at least 100 mg of cations of bivalent metal and having a pH ranging between 3 and 5, comprising a step in which at least the unhydrolyzed globular proteins are subjected to a step of direct steam injection (DSI) at specific retention values, such as a holding temperature of 100 to 140°C for a holding time of about 0.5 to 10 seconds, preceded by a homogenization step. Such a method is a valuable tool in the process of obtaining compositions based on whey comprising, per 100 ml of said composition, a high concentration of whey, in particular between 9 and 20 g, fat and divalent metal cations.
[0027] In another embodiment, the invention provides a method for preparing a sterilized acidic semi-solid liquid enteral composition according to the invention comprising the consecutive steps of: a) preparing an aqueous solution containing amounts of divalent metal cations, in in particular calcium and magnesium, unhydrolyzed globular proteins and fat, so that said sterilized acidic semi-solid liquid enteral composition comprises, per 100 ml of said composition, from 9 to 20 g of unhydrolyzed globular proteins, fat and at least 100 mg of divalent metal cations and having a pH ranging between 3 and 5; b) homogenization of the resulting solution essentially obtained in step a); c) subjecting the resulting solution essentially obtained from step b) to a direct steam injection process at a holding temperature of 100 to 140°C for a holding time of about 0.5 to 10 seconds.
[0028] In another embodiment, the invention provides a sterilized acidic liquid or semi-solid enteral nutritional composition obtainable or obtainable by means of a method according to the invention. Such a product is, in particular, characterized by a relatively low astringency and/or grittiness compared to a product having a comparative ingredient composition that has been obtained using a conventional technique or a method in which DSI is carried out prior to homogenization. DETAILED DESCRIPTION OF THE INVENTION Definitions
[0029] Within the context of the present invention, an elderly person is a person of 50 years of age or older, in particular of 55 years of age or older, more particularly of 60 years of age or older, even more particularly of 65 years of age of age or older. This very broad definition takes into account the fact that the average age varies between different populations, on different continents, etc. Most countries in the developed world have accepted the chronological age of 65 as a definition of an "elderly" or older person (linked to the age at which pension benefits can begin) but, like many Western concepts, this it has not adapted well, for example, to the situation in Africa. At the moment, there is no standard United Nations (UN) numerical criteria, but the UN agrees that the cutoff is +60 years to refer to the elderly population in the Western world. More traditional definitions in Africa of an elderly or "older" person correlate with chronological ages of 50 to 65 years, depending on environment, region and country.
[0030] Within the context of the present invention, enteral means any form of administration that involves any part of the gastrointestinal tract, i.e., by mouth (orally), by gastric feeding tube, duodenal feeding tube or rectally, in particular by mouth (orally). Thus, when referring to an enteral composition, this means that the composition is suitable for enteral administration.
[0031] Within the context of the present invention, the term "astringency" is used for a sensation of wrinkling or dryness in the mouth, which appears after a time in the oral cavity when consuming a food. This "astringent" sensation is also characterized by terms such as rough, dry, coating or film-forming sensation in the mouth, suggesting insoluble finely divided particles in the mouth after consumption of a food. Consequently, astringency is not a taste but a physical sensation in the mouth and a time-dependent sensation in the oral cavity. In the same sense, the term "non-astringent" is used, that is, when no sensation of wrinkling or dryness in the mouth is observed in the oral cavity when consuming a food product, such as by a panel of trained experts, in a procedure test as follows. The "astringency value" may, as described in the Examples below, be determined or measured by a panel of trained experts following specific conventional sensory methods or by other analytical methods such as the "Saliva-Drink Interaction Test" as described. in WO 2009/112036. In the context of the present invention, the term "reduced astringency" is used to denote an astringency which is reduced, possibly the total absence of a noticeable astringency, compared to a composition comprising non-hydrolyzed acidic globular proteins such as whey , having a high amount of protein and a high amount of calcium, but produced with a method according to the state of the art.
[0032] The term "sandiness" also refers to a sensory property of a liquid or semi-solid composition and typically refers to the presence of grains, which causes a strange sensation that lingers on the tongue as a distinct taste. This property can be considered as the opposite of "smoothness" or "smooth mouthfeel" and is an important factor for the acceptance of liquid compositions as well as semi-solids.
[0033] Within the context of the present invention, the term "sterilization treatment" and the term "sterilization" are intended to comprise any method of using heat (sterilization, pasteurization), radiation (UV treatment) and/or filtration ( ultrafiltration, diafiltration, nanofiltration) to reduce the number of or remove possible pathogens. Preferably, the sterilization treatment includes a heat treatment at a high temperature for a short period, such as a UHT (Ultra High Temperature) treatment. Consequently, in the context of the present invention, pasteurization is comprised within sterilization.
Within the context of the present invention, a "sterilized composition" is a composition that is obtained or obtainable by subjecting a composition to a sterilization treatment. In general, the amount of potentially pathogenic microorganisms in the sterilized composition meets food safety requirements as applicable, for example, in the United States or the European Union. In particular, a composition sterilized according to meets such requirement for at least 6 months, preferably at least 12 months, when stored in sealed packages at room temperature (20°C).
[0035] Within the context of the invention, pH is the pH as measurable with a pH electrode, calibrated at a pH of 4 and pH of 7, at a temperature of 20°C.
[0036] Within the context of the invention, viscosity is the measurable viscosity using an Anton Paar Physica MCR301 rheometer with a CP50-1/PC cone (diameter 50 mm, 1° difference between middle and outside) at 20°° C to 100 s-1.
[0037] Within the context of the invention, in general, the useful life of a product is the period, from its manufacture, during which the product is suitable for consumption. In particular, during its shelf life, the product maintains an acceptable microbiological quality, maintains fluidity, a pH in the range of 3 to 5, 9 to 20 g per 100 ml of unhydrolyzed globular protein, fat and at least 100 mg of cations of divalent metal in the product per 100 ml of the said product. In a preferred embodiment, the product maintains a viscosity of about 200 mPa.s or less, more preferably 100 mPa.s or less during its shelf life.
[0038] The term "about" is, in particular, used here to indicate a range of ±10%, more in particular ±5% around a given value. Globular Proteins
The invention relates, in general, to globular proteins. Globular proteins can be single peptide chains, two peptide chains or larger peptide chains which interact in the usual ways. A globular protein can have portions of the chains with helical structures, pleated structures or completely random structures. Globular proteins are relatively spherical in shape, as the name implies. In the art, globular proteins are described as proteins of which the protein chain, including the elements of secondary structure, is tightly folded into a more or less spherical shape (cf. Dairy Science and Technology, 2nd ed ISBN 0-8247-2763 -0). The tertiary structure assumed by a globular protein molecule tends to be such that the non-polar side chains are directed inwards to allow interaction with each other and the polar side chains are typically oriented outwards so that they are exposed to adjacent polar water molecules. A globular protein here is to be understood as a protein which is globular in its undenatured state. They are distributed in plant and animal tissues. For example, albumins can be found in blood (serum albumin), milk (lactalbumin), egg white (ovalbumin), lentils (legumelin), beans (phaseolin), and wheat (leucosin). Globulins can be found in blood (serum globulins), muscle (myosin), potatoes (tuberin), Brazil nuts (excelsin), hemp (edestine), whey (lactoglobulins, immunoglobulins and lactoferrins), peas and lentils (legumine , vicilin) and soy. Also, many enzymes and other plant proteins are globular proteins. More specifically, the invention relates to a globular protein selected from the group consisting of whey protein, pea protein, soy protein and any mixture thereof, more particularly whey protein.
When referring here to an "unhydrolyzed" globular protein, this means that the protein is either totally intact or contains fragments hydrolyzed only to a lesser extent. A smaller extent is a measure by which the nature of the globular protein is essentially maintained. The hydrolyzed fragments - if present in general - comprise less than 10% by weight such as, for example, 1 to 5% by weight relative to the total weight of the globular protein.
[0041] Consequently, the term globular protein means the collection of proteins which are globular in nature, but may contain small amounts of hydrolyzed fragments and/or unfolded fragments.
[0042] The amount of unhydrolyzed globular protein, preferably whey, varies between 9 and 20 g per 100 ml. Preferably, the amount of unhydrolyzed globular protein, preferably whey, ranges between 9 and 16 g per 100 ml. Advantageously, the lower limit on the amount of unhydrolyzed globular protein, preferably whey, is any of 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 or 19 g per 100 ml. Advantageously, the upper limit on the amount of unhydrolyzed globular protein, preferably whey, is any of 20, 19, 18, 17, 16, 15, 14, 13, 12, 11 or 10 g per 100 ml. More preferably, the amount of unhydrolyzed globular protein, preferably whey, ranges between 9 and 20 and 9 or 18, or 9 and 16 or 9 and 14 and 9 or 12 or 10 and 20 or 10 and 18 or 10 and 16 or 10 and 15 or 10 and 14 or 10 and 12 g per 100 ml. In a specific embodiment, the amount of unhydrolyzed globular protein, preferably whey, is equal to about 10 g per 100 ml of the composition. Preferably, the amount of unhydrolyzed globular protein is at least 85% by weight of the total proteinaceous matter in the composition according to the invention, the remainder of the proteinaceous matter being selected from the group comprising a non-globular protein, a hydrolyzed protein, an oligopeptide, a peptide and a free amino acid.
[0043] In a specific embodiment, the non-globular protein is selected from the group of casein, caseinate, micellar casein isolate and any mixture thereof.
[0044] In a specific embodiment, the free amino acid is selected from the group of branched-chain amino acids and salts thereof; in a particular embodiment, the free amino acid is L-leucine. Whey Proteins
[0045] One of the most superior classes of food protein is whey protein. It has an excellent amino acid profile for the purposes of the present invention, a high amount of cysteine, rapid digestion and are interesting bioactive proteins (lactoglobulins, immunoglobulins and lactoferrins). Nutritionally speaking, whey protein is known as a naturally complete protein because it contains all the essential amino acids needed in the daily diet. Also, it is one of the richest sources of branched chain amino acids (Branched Chain Amino Acids - BCAAs, in particular leucine), which play an important role in muscle protein synthesis. Furthermore, some of the individual components of whey protein have been shown to prevent viral and bacterial infections and modulate immunity in animals. Whey protein is the preferred protein choice for the treatment of people suffering from sarcopenia, but it is also indicated for healthy people such as sportsmen and elderly (active).
[0046] As a source of whey protein to be used in the present invention, any commercially available whey protein source can be used or any whey protein obtained by any process for preparing whey. milk known in the art, as well as whey protein fractions prepared from it or proteins that make up the bulk of whey proteins, being β-lactoglobulin, α-lactalbumin and serum albumin such as liquid whey or whey powder such as whey protein isolate (Whey Protein Isolate - WPI) or whey protein concentrate (Whey Protein Concentrate - WPC). Whey Protein Concentrate is rich in whey protein, but it also contains other components such as fat and lactose. In addition, whey from sweet whey may contain glycomacroprotein (GMP), a non-globular protein related to casein, which is also soluble at a pH at which whey proteins are soluble and therefore difficult to separate from it. Typically, whey protein concentrate is produced via membrane filtration. Whey protein, on the other hand, mainly consists of whey proteins with a minimal amount of fat and lactose. Whey protein isolate generally requires a more stringent separation process, such as a combination of microfiltration and ultrafiltration or ion exchange chromatography. It is generally accepted that a whey protein isolate refers to a mixture in which at least 90% by weight of the solids is whey protein. A whey protein concentrate is understood to have a whey protein content between the initial amount in the by-product (about 12% by weight) and a whey protein isolate. In particular, sweet whey obtained as a by-product in cheese production, acid whey, obtained as a by-product of casein acid production, native whey, obtained by microfiltration of milk or rennet, obtained as a by-product in the manufacture of rennet casein, they can be used alone or in combination as the source of globular whey proteins.
[0047] Furthermore, whey proteins can originate from a variety of mammalian species such as, for example, cows, sheep, goats, horses, buffaloes and camels. Preferably, the whey protein is of bovine origin.
[0048] Preferably, the whey protein source used for preparing a product according to the invention is available as a powder, preferably, the whey protein source is selected from the group consisting of concentrate of whey protein (Whey Protein Concentrate - WPC), whey protein isolate (Whey Protein Isolate - WPI) and any mixture thereof.
According to a specific modality, whey is a mixture of non-acidified (ie neutral) WPI and acidified WPI. Values of acidified and non-acidified WPI can vary between 10% by weight and 90% by weight, so that any proportion by weight is obtained between 10/90 and 90/10. Preferably, the weight ratio of acidified:neutral whey is in the range of 50:50 to 70:30. An acidified:neutral whey weight ratio of about 60:40 is particularly preferred.
[0050] Whey protein isolate essentially consists of a mixture of β-lactoglobulin, α-lactalbumin and serum albumin and optionally GMP if the whey source is sweet whey. The first three proteins are globular proteins that are sensitive to aggregation in the denatured state. The β-lactoglobulin denaturation temperature is pH dependent; at a pH of 6.7, irreversible denaturation of the protein occurs when it is heated to temperatures above about 65°C. In the denatured state, a free thiol group is exposed. This free thiol group can initiate inter-protein disulfide interactions that lead to a polymerization reaction, resulting in the formation of aggregates. Also, two disulfide bridges, present in native β-lactoglobulin, are involved in the polymerization reaction and other sulfur-containing groups, including cysteine residues, are also believed to play a role.
[0051] α-lactalbumin also has a denaturation temperature of about 65°C. Since α-lactalbumin does not have a free thiol group (only four disulfide bridges), pure α-lactalbumin solutions are not irreversibly denatured under most processing conditions. However, in the presence of β-lactoglobulin, as is the case, for example, in a whey protein concentrate or isolate, α-lactalbumin is more sensitive to irreversible denaturation upon formation of α-lactalbumin/β- complexes lactoglobulin, in which also disulfide bridges in β-lactoglobulin and α-lactalbumin are involved via exchange reactions. Furthermore, it is considered that the fact that α-lactalbumin contains cysteine residues contributes to a certain sensitivity to irreversible denaturation.
[0052] Denatured β-lactoglobulin and α-lactalbumin are both sensitive to calcium; this is particularly the case in the pH range of about 8, where the protein carries a net neutral to negative charge. At a pH of 4, the protein carries a net positive charge and is less (but still) sensitive to calcium-induced aggregation.
[0053] The size, shape and density of protein aggregates in a matrix are influenced by a number of environmental and processing parameters, including temperature, heating rate, pressure, shear, pH and ionic strength and other matrix components such as , for example, carbohydrates, minerals, fatty acids, etc. Depending on the combination of these parameters and ingredients, the aggregates can form a space-filling network (gel), fibrils or compact microparticles. For example, microparticulated whey can be formed under specific conditions of ionic strength and shear. These particles have a compact structure, a high intrinsic viscosity and a low specific volume. Furthermore, it is known that there is a relationship between aggregate size and heating temperature for microparticle whey produced under shear conditions. Microparticle Whey Protein has received much interest recently for application as a fat substitute or viscosity enhancer for yogurt.
[0054] One of the main problems encountered in the production of ready-to-use liquid compositions containing globular proteins in general and whey proteins in particular is their limited processability and heat sensitivity. Once these proteins are heated above their denaturation temperature in a sterilization process, they unfold and are transformed into a reactive state, polymerizing into aggregates or gels. As a result, the thermally treated liquid composition exhibits undesirable sensory attributes such as chalky appearance, gritty, lump formation. Furthermore, the shelf life of these products is limited by the fact that sediments and/or cream layers are formed soon after production or thickening occurs over time. In a composition with a high amount of globular protein, in particular whey, these instabilities are even more accentuated and result in products with an undesirable high viscosity and extensive fouling and blocking of the heating equipment.
Surprisingly, the inventors have now found that it is possible to prepare a sterilized acidic liquid or semi-solid enteral nutritional composition by means of a method in which a composition comprising mainly globular proteins as a protein source, whey proteins in particular, is subjected to a specific heat treatment comprising a step of subjecting the whey proteins to a DSI treatment under conditions which may, per se, be insufficient to sterilize or pasteurize the composition comprising the globular proteins, in particular whey proteins. milk.
[0056] Without being bound (or restricted) by theory, it is believed that increasing temperature has a different effect on both denaturation and aggregation. While under a temperature of about 100°C, the aggregation rate is greater than the rate of denaturation, this behavior is quickly reversed at a temperature above about 100°C. At a temperature below about 100°C, heating leads to the formation of long strains of proteins that can form disulfide bridges and aggregate and form large particles that eventually settle. At a temperature above about 100°C, globular proteins quickly begin to denature. Thus, a slow heat treatment just above the whey denaturation temperature leads to extensive polymerization and bulky protein aggregates. Furthermore, when whey is heated to elevated temperatures (ie, well above the protein's denaturation temperature, for example, about 110°C) by means of a slow heating process, i.e. where the temperature of the protein solution is gradually increased, eg 0.1 to 2°C per second, eg using retort, plate or tubular heat exchangers, whey exhibits extensive polymerization during heating when process temperatures exceed the temperature window above the whey protein denaturation temperature. As a result, the product is very thick, irregular, sandy and extensive fouling is observed in the heating apparatus, in particular when large amounts of calcium are present per 100 ml of composition such as, for example, above 100 mg, more particularly above 200 mg in compositions comprising 9 to 20 grams of globular protein, in particular whey protein.
[0057] Using the method according to the invention, through rapid and brief heating of globular proteins well above the denaturation temperature of whey protein, the thiol group of β-lactoglobulin, the main component of whey protein of milk, is exposed very quickly and termination reactions that form disulfide bridges dominate soon after heating. As a result, small compact whey protein particles are formed which are largely inert in any other heat treatment. Thus, surprisingly, it has been found that the time for whey proteins to be consumed in a temperature window above the denaturation temperature should be minimized.
[0058] Surprisingly, as a result of said treatment, a resulting sterilized liquid or semi-solid acidic enteral nutritional composition has a long shelf life, typically of at least 6 months, preferably of 12 months or more, satisfactory organoleptic properties such as none or a low astringency and/or no or low grittiness compared to a prior art sterilized liquid or semi-solid acidic enteral nutritional composition. Stabilizing Polysaccharide
[0059] In a preferred embodiment of this invention, the stabilized acidic liquid or semi-solid enteral nutritional composition also comprises a polysaccharide capable of stabilizing the small compact protein particles that form upon heat treatment. These polysaccharides are also referred to herein as "stabilizing polysaccharides".
[0060] Without limiting the scope of the invention, it has been assumed that certain polysaccharides present positively and negatively charged groups or regions at a pH below the isoelectric point (IsoElectric Point - IEP) of whey protein. At such a pH, the protein will have a net positive charge, which is assumed to interact with the negatively charged groups of the polysaccharide. This interaction results in the protein particles being surrounded by the large polysaccharide molecules, decreasing the likelihood that protein particles will get too close to each other and form aggregates. Furthermore, it is assumed that long polysaccharide chains can form networks within the liquid matrix, preventing sedimentation of the protein particles.
[0061] Therefore, in a preferred embodiment, the stabilizing polysaccharide is a polysaccharide having positive as well as negatively charged groups at a pH within the range of 3-5, eg at a pH of 4.2. Furthermore, it is preferred that the stabilizing polysaccharide does not interact with calcium ions to form firm gel structures. Polysaccharides that can be suitably used for purposes of the present invention include high methoxy pectin and carboxy methyl cellulose. Preferred examples of carboxy methyl celluloses which can be suitably used in accordance with the invention include Clear + Stable 30 PA, Clear + Stable 100 PA and Clear + Stable 2000 PA (Dow chemical). The term "high methoxy pectin" here is to be understood as a methoxy pectin in which at least 50% of the galacturonic acid groups are esterified with a methyl group.
[0062] In one embodiment of the invention, the stabilizing polysaccharide is high methoxy pectin which is typically used at a concentration of 0.01-1% (wt/v), preferably 0.02-0, 5% (weight/v), more preferably 0.05-2% (weight/v), e.g. in a concentration of 0.1% (weight/v).
[0063] In another embodiment of the invention, the stabilizing polysaccharide is carboxy methyl cellulose which is typically used at a concentration of 0.1-10% (wt/v), preferably 0.2-5% (wt. /v), more preferably 0.5-3% (weight/v), even more preferably in a concentration of 1-2% (weight/v). Direct steam injection
[0064] Direct Steam Injection (DSI) involves the release of water vapor (water at a temperature above 100°C) into a liquid with a lower temperature than steam. The vapor condenses and supplies its heat to the surrounding liquid. Since heat is transferred through direct contact between the vapor and the liquid, therefore, this method is used only when dilution and an increase in liquid mass are acceptable. Therefore, the liquid to be heated is generally water or an aqueous composition, such as a nutritional composition. Furthermore, after rapid cooling of the heated liquid, most of the added water vapor is lost again by evaporation under vacuum. DSI has been used in the food industry since the early 1930s for use as a sterilization treatment and its principles are known to those skilled in the art and will not be further described in detail here. Commercial apparatus can be purchased, for example, from Tetra Pak Processing Systems BV, Houten, The Netherlands.
[0065] In the present application, DSI is applied for non-sterilizing purposes, primarily under non-sterilizing conditions. An overview of the DSI conditions according to the present application, compared to conditions for UHT treatment is shown in Figure 1.
[0066] Recently, the use of DSI for non-sterilization purposes was described in WO2007/108827 (Abbott) for reducing the viscosity of a high energy milk protein isolate composition (225-325 kcal/ml) (comprising about 20% whey) for MPI amounts of between 6.7 and 12.6 g/100 ml (which corresponds to about 1.3 to 2.5 g of whey per 100 ml of composition liquid). However, no examples have been provided illustrating the claimed effect, nor is it described that the effect is related to a reduction in astringency or that this can be applied to compositions predominantly based on whey, such as comprising 9 to 20 g /100 ml whey protein. Composition preparation method
[0067] The invention provides a method for preparing a sterile liquid or semi-solid acidic enteral composition comprising 9 to 20 g of unhydrolyzed globular proteins, fat and at least 100 mg of divalent metal cations and having a pH ranging between 3 and 5 , comprising a step in which at least the unhydrolyzed globular proteins are subjected to a direct steam injection (Direct Steam Injection - DSI) at specific retention values, such as a retention temperature of 100 to 140°C during a retention time from about 0.5 to 10 seconds, preceded by a homogenization step.
[0068] In a preferred embodiment of the invention, a process as defined above is provided, wherein the step where at least the unhydrolyzed globular protein is subjected to DSI treatment is followed by a sterilization step.
[0069] As will be understood by those skilled in the art, treatment of DSI as described herein may result in the liquid or semi-solid becoming sterilized "commercially sterilized" without performing a distinct sterilization depending, for example, on the conditions applied during the treatment of DSI . Consequently, embodiments in which the process described above is not followed by a separate sterilization step are also within the scope of the present invention.
[0070] In another preferred embodiment of the invention, a process as defined above is provided, wherein at least the unhydrolyzed globular protein and a stabilizing polysaccharide are subjected to homogenization, followed by DSI treatment and optionally a sterilization step .
[0071] The invention also provides a method for preparing a sterilized liquid or semi-solid acidic enteral nutritional composition comprising, per 100 ml of said composition, 9 to 20 g of unhydrolyzed globular protein, fat and at least 100 mg of metal cations divalent and having a pH ranging between 3 and 5 comprising the consecutive steps of: a) preparing an aqueous solution containing amounts of divalent metal cations, in particular calcium and magnesium, unhydrolyzed globular proteins, fat and optionally stabilizing polysaccharides , so that said sterilized acidic liquid or semi-solid enteral composition comprises, per 100 ml of said composition, from 9 to 20 g of unhydrolyzed globular proteins, fat, at least 100 mg of divalent metal cations and, optionally, the polysaccharide stabilizing and having a pH ranging between 3 and 5; b) homogenization of the resulting solution essentially obtained by step a); c) subjecting the resulting solution essentially obtained from step b) to a direct steam injection process at a holding temperature of 100 to 140°C for a holding time of about 0.5 to 10 seconds; and, optionally d) subjecting the resulting solution essentially obtained from step c) to a sterilization treatment.
[0072] By "consecutive" it is meant that the order in which the steps are implemented is: step a), followed by step b), followed by step c), followed (optional) by step d). Steps that implement other actions may be intermittently added to the sequence of steps a), b), c) and d), as long as the order of steps a), b), c) and (optionally) d) is not changed. Typical steps that can be added are: - Preparation of other solutions; - Dissolution of other macro constituents of a nutritional composition (eg carbohydrates, fiber); - Dissolution of other constituents, such as minerals, amino acids, etc.; - Mix; - Pre-heating; - pH adjustment; - Quick cooling.
[0073] In a particularly preferred embodiment of the present invention, a method for preparing a sterilized semi-solid acidic enteral composition, also referred to as "spoon-consumable composition", is provided, as described in any of the foregoing, comprising the additional step f) adding a thickener or gel-forming agent to the liquid before or after DSI treatment.
[0074] By "the resulting solution essentially obtained" is meant the solution essentially resulting from a previous process step, provided that the solution may contain other components as a consequence of an intermittent process step e) such as, but without limitations, the addition of other nutritional components.
[0075] A preferred process according to the present invention for preparing a sterilized acidic liquid or semi-solid enteral composition according to the invention comprises the consecutive steps of: e1) dissolving an amount of unhydrolyzed globular proteins in a first aqueous solution so that said sterile liquid or semi-solid acidic enteral composition obtained comprises, per 100 ml of said composition, from 9 to 20 g of unhydrolyzed globular proteins; e2) dissolving a quantity of minerals comprising divalent metal cations, in particular calcium and magnesium, in a second aqueous solution, so that said obtained sterile liquid or semi-solid acidic enteral composition comprises, per 100 ml of said composition, at least 100 mg of divalent metal cations; preferably, this is done at a pH of about 4.3; e3) mixing the second aqueous solution containing divalent metal cations, in particular calcium and magnesium, with the first aqueous solution comprising an amount of unhydrolyzed globular proteins, so that said obtained sterile liquid or semi-solid acidic enteral composition comprises, per 100 ml of said composition, from 9 to 20 g of unhydrolyzed globular proteins and at least 100 mg of divalent metal cations; e4) adding an amount of fat, preferably a liquid fat, to the resulting solution essentially obtained in step e3); b) homogenization of the resulting solution essentially obtained by step e4); e5) preheating the resulting solution essentially obtained by step b); c) subjecting the resulting solution essentially obtained by step e5) to a direct steam injection process at a holding temperature of 100 to 140°C for a holding time of about 0.5 to 10 seconds; e6) rapid cooling of the resulting solution essentially obtained by step c); e7) optionally, adjusting the pH of the resulting solution obtained by step e6); and, optionally d) subjecting the resulting solution essentially obtained by step e7) to a sterilization treatment.
[0076] A preferred process according to the present invention for preparing a sterilized liquid or semi-solid acidic enteral composition comprising, per 100 ml of said composition, from 9 to 20 g of unhydrolyzed globular proteins, fats and carbohydrates according to the invention, comprising the consecutive steps of: e1) dissolving an amount of non-hydrolyzed globular proteins and an amount of carbohydrates in a first aqueous solution, so that said sterilized liquid or semi-solid acidic enteral composition obtained comprises, per 100 ml of said composition, from 9 to 20 g of unhydrolyzed globular proteins; e2) dissolving a quantity of minerals comprising divalent metal cations, in particular calcium and magnesium, in a second aqueous solution, so that said obtained sterile liquid or semi-solid acidic enteral composition comprises, per 100 ml of said composition, at least 100 mg of divalent metal cations; preferably, this is done at a pH of about 4.3; e3) mixing the second aqueous solution containing divalent metal cations, in particular calcium and magnesium, with the first aqueous solution comprising an amount of unhydrolyzed globular proteins and an amount of carbohydrates, so that said sterilized liquid or semi-solid acidic enteral composition obtained comprises, per 100 ml of said composition, from 9 to 20 g of unhydrolyzed globular proteins and at least 100 mg of divalent metal cations; e4) adding an amount of fat, preferably a liquid fat, to the resulting solution essentially obtained by step a); e) homogenization of the resulting solution essentially obtained by step e4); e5) preheating the resulting solution essentially obtained by step b); f) subjecting the resulting solution essentially obtained by step e5) to a direct steam injection process at a holding temperature of 100 to 140°C for a holding time of about 0.5 to 10 seconds; e6) rapid cooling of the resulting solution essentially obtained by step c); e7) optionally, adjusting the pH of the resulting solution obtained by step e6); and, optionally g) subjecting the resulting solution essentially obtained by step e7) to a sterilization treatment.
[0077] Another preferred process according to the present invention for preparing a sterilized liquid or semi-solid acidic enteral composition according to the invention comprises the consecutive steps of: e1) dissolving an amount of unhydrolyzed globular proteins and a stabilizing polysaccharide in a first aqueous solution, so that said sterile liquid or semi-solid acidic enteral composition obtained comprises, per 100 ml of said composition, from 9 to 20 g of unhydrolyzed globular proteins; e2) dissolving a quantity of minerals comprising divalent metal cations, in particular calcium and magnesium, in a second aqueous solution, so that said obtained sterile liquid or semi-solid acidic enteral composition comprises per 100 ml of said composition of at least 100 mg of divalent metal cations, preferably this is carried out at a pH of about 4.3; e3) mixing the second aqueous solution containing divalent metal cations, in particular calcium and magnesium, with the first aqueous solution comprising an amount of unhydrolyzed globular proteins, so that said obtained sterile liquid or semi-solid acidic enteral composition comprises, per 100 ml of said composition, from 9 to 20 g of unhydrolyzed globular proteins and at least 100 mg of divalent metal cations; e4) adding an amount of fat, preferably a liquid fat, to the resulting solution essentially obtained in step e3); h) homogenization of the resulting solution essentially obtained by step e4); e5) preheating the resulting solution essentially obtained by step b); i) subjecting the resulting solution essentially obtained by step e5) to a direct steam injection process at a holding temperature of 100 to 140°C for a holding time of about 0.5 to 10 seconds; e6) rapid cooling of the resulting solution essentially obtained by step c); and, optionally e7) pH adjustment of the resulting solution obtained by step e6).
[0078] Step E1) is preferably carried out at 1 to 70°C, preferably between 20 and 55°C. At higher temperatures, less foam is observed. The proteins are dissolved in a volume of an aqueous solution, preferably water such as, for example, demineralized water, demi-water or tap water so that, after dilution with other solutions in subsequent steps, a final volume is obtained so that this final volume comprises 9 to 20 g of unhydrolyzed globular proteins per 100 ml of sterile liquid or semi-solid enteral acidic composition.
[0079] Step E2) is preferably carried out at 1-90°C, preferably at 20 to 30°C. Preferably, this step is carried out at a pH of about 4.3. At this pH, mineral salts (in the form of salts, hydroxides, etc.) dissolve more easily. The minerals are dissolved in a volume of an aqueous solution, preferably water such as, for example, demineralized water, demi-water or tap water so that, after dilution with other solutions in subsequent steps, a final volume is obtained so that this final volume comprises at least 100 mg of unhydrolyzed globular proteins per 100 ml of sterile liquid or semi-solid enteral acidic composition.
[0080] Preferred embodiments of the invention provide any of the processes defined above in which step e7) of adjusting the pH of the solution obtained in step E6) is carried out. Furthermore, in one embodiment, it is preferred that steps e7) and d) are both performed.
[0081] Step a) is carried out preferably at 1 to 90°C, preferably at 20 to 30°C.
[0082] Step b) is preferably carried out at 1-90°C, preferably at 60 to 70°C. Preferably, the mixture is pumped by a high pressure pump through a narrow opening valve. Due to the very narrow aperture, a high speed is introduced. When the pressure is 60 MPa (600 bar), the maximum speed will be about 600 m/s. Potential energy will be transformed into kinetic energy, resulting in an increase in temperature and turbulence. The rise in temperature corresponds with P/4, so homogenization at 60 MPa results in a temperature rise of 15°C. Strong turbulence results in a breakdown of the fat globules. Since the residence time of the product in the valve is very short, a large energy density is created (1011 -1012 Wm-3). As a consequence of the high energy density, oil droplets are broken up into smaller droplets. Since energy dissipation is not constant, the droplets formed will vary in size so that a particle size distribution will be created. The better the valve of the homogenizer, the smaller the particle size distribution. If a valve is not in a perfect state, a wider particle size distribution will be produced, giving larger droplets, which can create product problems such as creaming.
[0083] Other steps can be performed at such temperatures that can be easily selected by those skilled in the art, without any inventive step depending, for example, on the apparatus used. Divalent Metal Cations
[0084] By the term "divalent metal cations" is meant any positively charged metal ion with a charge equal to two. In particular, understand ions of magnesium (Mg2+), calcium (Ca2+), zinc (Zn2+) and iron (Fe2+), preferably calcium (Ca2+), since these ions appear in relatively high concentrations in nutritional compositions, in to comply with FSMP regulations. Preferably, the composition according to the invention is a nutritionally complete composition.
[0085] In an embodiment of the present invention, the amount of divalent metal ions is at least 100 mg of divalent metal cations per 100 ml of composition.
[0086] Preferably, the amount of divalent metal ions ranges between 100 and 600 mg/100 ml mg/100 ml and preferably between 200 and 500 mg/100 ml mg/100 ml. In a specific modality, the amount of divalent cations is about 270 mg/100 ml.
[0087] Preferably, the divalent metal cation is selected from the group consisting of Ca, Mg and any mixture thereof, preferably Ca.
[0088] Preferably, the amount of calcium ranges between 100 and 600 mg/100 ml mg/100 ml and more preferably between 200 and 500 mg/100 ml mg/100 ml. In another embodiment, the amount of calcium is about 250 mg/100 ml.
[0089] Preferably, the amount of magnesium ranges between 10 and 100 mg/100 ml mg/100 ml and more preferably between 15 and 70 mg/100 ml mg/100 ml. In another embodiment, the amount of magnesium is about 19 mg/100 ml. Fat
According to the invention, the present sterilized liquid or semi-solid enteral acid composition will comprise an amount of fat (i.e., lipids). The amount of fat can vary between 5 and 95%, preferably between 10 and 70%, more preferably between 15 and 65% with respect to the total energy amount of the composition.
[0091] Regarding the type of fat, a wide choice is possible, as long as the fat is of food quality. In an advantageous embodiment, the composition comprises a fat which is liquid under ambient conditions, that is, at ambient temperature and at a pressure of 1 atm.
[0092] The fat can be either an animal fat or a vegetable fat or both. Although animal fats, such as lard or butter, have essentially equal caloric and nutritional values and can be used interchangeably, vegetable oils are highly preferred in the practice of the present invention because of their ready availability, liquid form, ease of formulation, absence of cholesterol. and lower concentration of saturated fatty acids. In another embodiment, the present composition comprises rapeseed oil, corn oil and/or sunflower oil.
[0093] Fat can include a source of medium chain fatty acids such as medium chain triglycerides (Medium Chain Triglycerides - MCT, mostly 8 to 10 carbon atoms in length), a source of long chain fatty acids such as such as long chain triglycerides (LCT, mostly at least 18 carbon atoms long) and fatty acids linked to phospholipids such as EPA or DHA or any combination of the two types of sources. MCTs are beneficial because they are easily absorbed and metabolized in a patient under metabolic stress. Furthermore, the use of MCTs will reduce the risk of nutrient malabsorption. LCT sources such as canola oil, rapeseed oil, sunflower oil, soybean oil, olive oil, coconut oil, palm oil, linseed oil, marine oil or corn oil are beneficial because it is known that LCTs can modulate the immune response in the human body.
[0094] In a specific embodiment, the fat comprises 30 to 60% by weight of animal, seaweed or fungal fat, 40 to 70% by weight of vegetable fat and optionally 0 to 20% by weight of MCTs based on total fat in composition. The animal fat preferably comprises a low milk fat content, i.e. less than 6% by weight, especially less than 3% by weight based on total fat. In particular, a mixture of corn oil, egg oil and/or canola oil and specific amounts of marine oil is used. Egg oils, seaweed oils and fish oils are a preferred source of non-vegetable fats. Especially for compositions which have to be consumed orally, in order to avoid the formation of unpleasant tastes and to diminish an aftertaste of fish, it is recommended to select ingredients that have a relatively low content of docosahexaenoic acid (DHA), that is. is less than 6% by weight, preferably less than 4% by weight based on total fat. Marine oils containing DHA are preferably present in the composition according to the invention in an amount of less than 25% by weight, preferably less than 15% by weight based on total fat. On the other hand, the inclusion of eicosapentaenoic acid (EPA) is highly desirable for maximum health effect. Therefore, in another embodiment, the amount of EPA may vary between 4% by weight and 15% by weight, more preferably between 8% by weight and 13% by weight based on total fat. The weight ratio of EPA:DHA is advantageously at least 6:4, for example 2:1-10:1. In another embodiment, the amount of EPA is very low, such as 0.1 to 1% by weight, preferably 0.3% by weight or 0.6% by weight, based on total fat.
[0095] Furthermore, the sterilized acidic liquid or semi-solid enteral composition according to the invention may advantageously comprise an emulsifier. In principle, any food grade emulsifier can be present. Suitable emulsifiers are commonly known. In general, the emulsifier contributes to the amount of energy from the fat in said composition. Digestible Carbohydrates
[0096] In a specific embodiment of the present invention, the sterilized acidic liquid or semi-solid enteral composition according to the invention further comprises a digestible carbohydrate. Preferably, the digestible carbohydrate provides between 20 to 60% of the total amount of energy in the composition according to the invention. Digestible carbohydrate can comprise simple or complex carbohydrates or any mixture thereof. Suitable for use in the present invention are glucose, fructose, sucrose, lactose, trehalose, palatinose, corn syrup, malt, maltose, isomaltose, partially hydrolyzed corn starch, maltodextrin, glucose, oligo- and polysaccharides.
[0097] The composition of digestible carbohydrates is preferably such that high viscosities, excessive sweetness, excessive browning (Maillard reactions) and excessive osmolarities are avoided. Acceptable viscosities and osmolarities can be obtained by adjusting the average chain length (average degree of polymerization; Degree of Polymerisation - DP) of digestible carbohydrates between 1.5 and 6, preferably between 1.8 and 4. In order to avoid excessive sweetness the total level of sucrose and fructose is preferably less than 60%, more preferably less than 52%, even more preferably less than 40% by weight of carbohydrate, especially of digestible carbohydrate. Long-chain digestible carbohydrates, such as starch, starch fractions and starch hydrolysates (DE > 6, DE < 20), may also be present, preferably in an amount of less than 25% by weight, especially less than 15% by weight of the digestible carbohydrates and less than 6 g/100 ml, preferably less than 4 g/100 ml of the total liquid enteral composition according to the invention. Vitamins, Minerals and Trace Elements
[0098] The sterilized acidic liquid or semi-solid enteral composition according to the invention may also contain a variety of vitamins, minerals and trace elements.
[0099] In one embodiment of the present invention, the sterilized liquid or semi-solid acidic enteral composition according to the invention provides all the necessary vitamins, most minerals and trace elements. For example, the composition according to the invention preferably provides about 1.1 mg of zinc per 100 ml of composition, which is beneficial for healing tissue repair in a patient. Preferably, the composition according to the invention provides 16 mg of vitamin C per 100 ml of the composition to help patients with more severe healing requirements. Furthermore, preferably, the composition according to the invention provides 1.2 mg of iron per 100 ml of the composition. Iron is beneficial in maintaining bodily fluids as well as circulatory system functions in an elderly patient.
[00100] The amount of phosphorus can be above 10 mg per g of protein and can reach, for example, 125 mg/100 ml of the total composition with a calcium to phosphorus weight ratio between about 1 and about 3. In another modality, the proportion is about 2.
[00101] Other ingredients may be present, such as vitamin A, carotenoids, vitamin D3, vitamin E, vitamin K, thiamine, riboflavin, niacin, pantothenic acid, vitamin B6, folic acid, vitamin B12, biotin, vitamin C, choline, lecithin and trace elements such as copper, manganese, selenium, molybdenum, chromium and iodine. Thickener/Gel Forming Agent
[00102] As stated above, in an embodiment of the present invention, a liquid composition according to the invention can be used as the basis for the manufacture of a semi-solid nutritional composition, also referred to as "spoon-consumable composition", such as like cream, pudding, paste, soup, ice cream or jam. For this purpose, a liquid composition according to the invention is processed to convert the low-viscosity composition according to the invention to a more viscous or solid one, for example, by adding thickeners or gel-forming agents and further processing of the mixture into the final semi-solid product, for example by subjecting it to a heat treatment. Thickeners and/or gelling agents may be present in the formulation at a later stage in the process or even dissolved along with nutrients early in the process. Thus, according to an embodiment, the invention relates to a semi-solid enteral nutritional composition obtained from a nutritional composition comprising, per 100 ml of said composition, from 9 to 20 g of unhydrolyzed globular protein, fat and hair. minus 100 mg of divalent metal cations and has a pH ranging between 3 and 5, upon combination with a thickener or gel-forming agent.
Many conventional thickeners and/or gel-forming agents can be used in accordance with the invention, including various gums such as locust bean gum, guar gum, xanthan gum, arabic gum, locust bean gum, etc.; alginates, agar, carrageenan, cellulose and cellulose derivatives, starches including modified starches, pectins, etc. In a preferred embodiment of the invention, starch or pectin is used as a thickener or gel-forming agent.
[00104] In one embodiment of the invention, the thickener or gel-forming agent is pectin which is typically used at a concentration of 0.05-5% (wt/v), preferably 0.1-1% (weight/v), more preferably 0.2-0.5% (weight/v), e.g. at a concentration of 0.35% (weight/v).
[00105] In another embodiment of the invention, the thickener or gel-forming agent is starch which is typically used in a concentration of 0.1-10% (w/v), preferably 0.2-5% (weight/v), more preferably 0.5-2% (weight/v), e.g. in a concentration of 1% (weight/v). In another modality, the thickener is applied in sufficient amounts to give the product the desired viscosity and/or structure. Preferably, the viscosity of a semi-solid product, also referred to herein as a spoon-consumable product, is within the range between 200-2500 mPa.s, preferably 300-2000 mPa.s, more preferably 400-1000 mPa.s .s, all measured at 20°C at a shear rate of 100 s-1. Such products meaning products to be consumed with a spoon are products that can easily be consumed by spoonfuls from a container or plate.
[00106] According to the present invention, liquid products are typically products that are capable of being spilled (at 20°C), in particular which can be spilled from an open container in which they are contained. In particular, a product is liquid or can be spilled if its viscosity, measured using the method as described in the Definitions section, is below 200 mPa.s.
[00107] In another preferred embodiment of the invention, the product to be consumed with a spoon is in the form of a hydrogel.
[00108] In an embodiment of the invention, the composition comprises a polysaccharide that functions as a thickener as well as a stabilizer. For example, high methoxy pectin can be used in sufficient amounts to convert the product into a more viscous or more solid product which, at the same time, will aid in the stabilization of protein particles typically through the mechanisms explained herein above. In a particularly preferred embodiment, the semi-solid composition comprises a combination of high methoxy pectin and a starch, typically in amounts sufficient to impart the desired viscosity and impart the stabilizing action described herein above. Nutritional Compositions
[00109] According to a preferred embodiment, the liquid enteral nutritional composition according to the invention comprises: a) about 10 g of non-hydrolyzed whey protein per 100 ml of the composition, said protein providing about 56% the amount of total energy in the composition; b) fat, which provides about 18% of the total amount of energy in the composition; c) optionally carbohydrates, which provide about 23% of the total amount of energy in the composition; d) about 250 mg per 100 ml of Ca and about 19 mg per 100 ml of Mg; and e) having a pH of about 4. Medical Use
[00110] The nutritional composition according to the invention can advantageously be used for the nutritional management of a person in need of it, in particular where the person is an elderly person, a person who is in an unhealthy state, a a person recovering from an unhealthy state, a person who is malnourished, a sportsman or an active elderly person. The nutritional composition according to the invention can advantageously be used for the prevention or treatment of a disease or condition involving muscle wasting in a mammal. Alternatively, the nutritional composition according to the invention can advantageously be used for the prevention or treatment of a disease or condition selected from the group of sarcopenia, muscle wasting, insufficient muscle protein synthesis, muscle degradation, muscle proteolysis, muscle atrophy , muscular dystrophy, muscle catabolism, loss of muscle mass, loss of muscle strength, loss of muscle endurance, loss of muscle function, loss of physical capacity, loss of physical performance, reduced mobility, frailty, surgery, disability, risk of falls and risk of fall-related fractures in a mammal. Preferably, said mammal is an elderly adult human being.
[00111] The term "nutritional management" herein is to be understood as providing a person with an amount of a nutrient or nutrients which corresponds to the recommended daily nutritional intake of said nutrient or nutrients for that person, in particular a person old woman. In order to determine for an individual what is the recommended amount of liquid or semi-solid acidic enteral nutritional composition according to the invention to be taken to obtain nutritional management of that person in a desired manner, those skilled in the art have several sources of detailed information to their willingness to achieve this goal. For example, specific tables or other sources of information from government authorities, such as the Food and Nutrition Information Center of the United States Department of Agriculture, may be consulted to enable a person to be supplied with a quantity of a nutrient or nutrients to which corresponds to the recommended daily nutritional intake of this nutrient or nutrients for that person, in particular an elderly person. Dosage
[00112] In a specific modality, the nutritional composition according to the invention is in the form of a complete food, that is, it can satisfy all the nutritional needs of the user. As such, it preferably contains 1200-2500 kcal per daily dosage. Daily dosage amounts are given in relation to a daily energy supply of 2000 kcal for a healthy adult with a body weight of 70 kg. For people of different condition and different body weight, the levels should be adapted accordingly. It should be understood that the average daily energy intake is preferably about 2000 kcal. The nutritional composition, which may be a complete food, may be in the form of multiple dosage units, for example from 4 (for example 250 ml/unit) to 40 (for example 20 ml/unit) per day for one 2000 kcal/day energy supply using the liquid enteral nutritional composition according to the invention.
[00113] The liquid enteral nutritional composition can also be a food supplement, for example, to be used in addition to a non-medical food. Preferably, as a supplement, the liquid enteral nutritional composition contains, per daily dose, less than 1500 kcal; in particular, as a supplement, the liquid enteral nutritional composition contains 400 to 1000 kcal per daily dose. The food supplement may be in the form of multiple dosage units, for example from 2 (250 ml/unit) to 10 (50 ml/unit) per day for an energy supply of 1000 kcal/day using the liquid enteral nutritional composition according to the invention.
[00114] In another embodiment of the present invention, a dosage unit comprises any amount of the liquid enteral nutritional composition according to the invention between 10 ml and 250 ml, the final values of this range included, preferably, any amount between 25 ml and 200 ml, the end values of this range included, more preferably any amount between 50 ml and 150 ml, the end values of this range included, most preferably about 125 ml. For example, for a person receiving unit dosages of 50 ml, 10 unit dosages per day may be provided to provide nutritional support using the liquid enteral nutritional composition according to the invention. Alternatively, for a person receiving 125 ml unit doses, 4 or 5 or 6 or 7 or 8 unit doses per day may be administered to provide nutritional support using the liquid enteral nutritional composition according to the invention. Such small dosage units are preferred because of better acceptance by the individual.
[00115] In another embodiment, the nutritional composition is administered as 1 to 2 servings per day, each serving comprising between 80 and 200 kcal, preferably about 125 kcal, preferably about 150 kcal. Preferably, the nutritional composition is administered as a daily serving. Use of a nutritional composition in a liquid form or for serving with a spoon may comprise 30 to 250 ml of the nutritional composition according to the invention, even more preferably 200 ml per serving.
[00116] In another embodiment of the present invention, the composition is provided in a ready-to-use liquid form and does not require reconstitution or mixing before use. The composition according to the invention can be fed by gavage or administered orally. For example, the composition according to the invention can be supplied in a can or bag.
[00117] In another embodiment of the present invention, the composition according to the invention is packaged. The package may have any suitable shape, for example a block-shaped cartouche, for example, to be emptied with a straw; a plastic package or container with a removable lid; a small-sized bottle, for example, for the 80 ml to 200 ml range; and small cups, for example, for the 10 ml to 30 ml range. Another suitable packaging mode is to include small amounts of liquid (eg, 10 ml to 20 ml) in edible solid or semi-solid casings or capsules, e.g., gelatin-like coatings and the like.
[00118] The invention will now be described by way of examples, which are not intended to be limiting. 1. EXPERIMENTAL Example 1: According to the invention Example 2: According to the invention Example 3: According to Example 1, with about 130 mg/100 ml of divalent metal cations Example 4: According to Example 1 with 100% by weight of unacidified WPI Example 5: According to Example 1 with 40% by weight acidified and 60% by weight of unacidified WPI Example 6: According to Example 1 with 116 g/l of whey and 400 mg/100 ml of Ca Example 7: According to Example 1 with 160 g/l of whey and 400 mg/100 ml of Ca Example 8: According to Example 1 with greater amounts of fat. Example 9: According to Example 1, with pH = 3.7 during DSI. Example 10: According to Example 1, with pH = 4.9 during DSI. Example 11: (using a reference method, comparative to Example 1, but with a homogenization after DSI treatment) Example 12: (using a reference method, comparative to Example 1, but without DSI treatment) Example 13: (comparative , as in Example 1, except for a concentration of less than 100 mg/100 ml of divalent cations) Example 14: According to the invention (product to be consumed with a spoon) Example 15: According to the invention (product to be consumed with a spoon). Example 1
[00119] To obtain 20 L of final product, 909 g of WPI and 1.412 g of pre-acidified WPI were dissolved to dissolve a total amount of 2000 g of whey protein in 12.7 kg of demineralized water. This mixture was mixed under gentle agitation to avoid excessive foaming. In this mixture, also 8 g of carotenoid mixture, 79 g of L-leucine, 6 g of L-isoleucine, 23 g of L-valine, 280 g of GOS syrup (45% pure weight/weight), 14 g of inulin fiber source (97% pure weight/weight), 31 g low viscosity pectin source (90% pure weight/weight) and 60 g high methoxy pectin source (35% pure weight/weight) and 505 g of sucrose was dissolved. The mixture was stirred for about 2 hours at room temperature until all macronutrients were evenly dissolved or dispersed. 91 g of calcium hydroxide was added to 1.346 g of demineralized water and stirred with a stirring rod for 5 minutes. 173 g of citric acid monohydrate were added to the calcium hydroxide solution, after which the mixture is stirred once more for 5 minutes at room temperature. 7 g of choline chloride, 6 g of sodium ascorbate, 9 g of potassium chloride, 11 g of tri-potassium citrate monohydrate, 30 g of magnesium chloride dihydrate and 34 g of trisodium citrate dihydrate were added to 492 g of demineralized water and stirred for about 1 hour at room temperature until all minerals were dissolved or dispersed evenly. The solution containing the macro ingredients was mixed with the solution containing calcium hydroxide and the solution containing the other minerals. This combined solution was stirred for several minutes to ensure even distribution of all components in the solution. The pH of this solution was adjusted to a pH of 4.3 using satis quantum lactic acid. The pH was measured at room temperature with an electrode directly in the solution. 19 g of soy lecithin and 278 g of canola oil were mixed at room temperature and subsequently heated to 60°C in a water bath. The oily mixture was added to the above solution. A pre-emulsion was formed by mixing the oil into the solution using an Ultra Thurrax. The newly formed mixture was homogenized at 60°C with 550+50 bar and cooled to room temperature. The emulsion was preheated to 60°C, heated using DSI to 115°C for 4 seconds and quickly cooled to 60°C. The emulsion was cooled to room temperature. After this treatment, the pH of the emulsion was adjusted to 4.0 using quantum satis lactic acid. The pH was measured at room temperature with an electrode directly in the solution. The dry matter of the product was adjusted by adding demineralized water to obtain the final dry matter required. The emulsion was mixed for about 5 minutes to evenly distribute the water and emulsion. The emulsion was preheated to 60°C using a plate heat exchanger and a UHT treatment provided. The product was filled into vials in a sterile chamber. Example 2
[00120] To obtain 20 L of final product, 909 g of WPI and 1.412 g of pre-acidified WPI were dissolved to dissolve a total amount of 2000 g of whey protein in 11.7 kg of tap water. This mixture was mixed under gentle agitation to avoid excessive foaming. In this mixture, also 79 g of L-leucine, 6 g of L-isoleucine, 23 g of L-valine, 280 g of GOS syrup (45% pure weight/weight) and 14 g of inulin fiber source (97 % pure weight/weight) were dissolved. The mixture was stirred for about 2 hours at room temperature until all macronutrients were evenly dissolved or dispersed. 8 g of carotenoid mixture was dissolved in 75 g of tap water, stirred for 5 minutes at room temperature and added to the macronutrient mixture. 85 g of calcium hydroxide was added to 1.255 g of tap water and stirred with a stirring rod for 1 minute. 161 g of citric acid monohydrate were added to the calcium hydroxide solution, after which the mixture is stirred again for 3 minutes at room temperature. 7 g of choline chloride, 8 g of calcium chloride dihydrate, 24 g of tri-potassium citrate monohydrate, 29 g of magnesium chloride dihydrate and 30 g of trisodium citrate dihydrate were added to 490 g of tap water and stirred during about 1 hour at room temperature until all minerals are dissolved or dispersed evenly. 5 g of mineral premix and 5 g of trisodium citrate dihydrate were added to 90 g of tap water and stirred for about 1 hour at room temperature until all minerals were dissolved or dispersed evenly. The solution containing the macro ingredients was mixed with the solution containing calcium hydroxide and the other two solutions containing minerals. This combined solution was stirred for several minutes to ensure even distribution of all components in the solution. 45 g of low viscosity pectin source (90% pure wt/wt), 80 g high methoxy pectin source (35% pure wt/wt) and 430 g sucrose are dry blended and added to the above solution described under gentle agitation at room temperature. The pH of this solution was adjusted to a pH of 4.3 using satis quantum lactic acid. The pH was measured at room temperature with an electrode directly in the solution. 19 g of soy lecithin and 278 g of canola oil were mixed at room temperature and subsequently heated to 60°C in a water bath. The oily mixture was added to the above solution. A pre-emulsion was formed by mixing the oil into the solution using an Ultra Thurrax. The newly formed mixture was homogenized at 60°C with 550+50 bar. The emulsion was preheated to 60°C, heated using DSI to 110°C for 4 seconds and quickly cooled to 60°C. The emulsion was cooled to room temperature. After this treatment, the pH of the emulsion was adjusted to 4.0 using quantum satis lactic acid. The pH was measured at room temperature with an electrode directly in the solution. The dry matter of the product was adjusted by adding running water to obtain the final dry matter required. The emulsion was mixed for about 5 minutes to evenly distribute the water and emulsion. 5 g of sodium ascorbate was added to the emulsion under gentle agitation. The emulsion was preheated to 60°C using a tube heat exchanger and a UHT treatment provided. The product was filled into vials in a sterile chamber. Example 3 (Example 1, with about 130 mg/100 ml of divalent metal cations)
[00121] To obtain 20 L of final product, 909 g of WPI and 1.412 g of pre-acidified WPI were dissolved to dissolve a total amount of 2000 g of whey protein in 12.7 kg of demineralized water. Before adding the proteins, 8 g of the carotenoid mixture was added to the water. This mixture was mixed under gentle agitation to avoid excessive foaming. In this mixture, also 79 g of L-leucine, 6 g of L-isoleucine, 23 g of L-valine, 280 g of GOS syrup (45% pure weight/weight), 15 g of inulin fiber source (97 % pure weight/weight), 31 g of low viscosity pectin source (90% pure weight/weight) and 60 g of high methoxy pectin source (35% pure weight/weight) and 505 g of sucrose were dissolved . The mixture was stirred for about 2 hours at room temperature until all macronutrients were evenly dissolved or dispersed. 46 g of calcium hydroxide was added to 673 g of demineralized water and stirred with a stirring rod for 5 minutes. 86 g of citric acid monohydrate were added to the calcium hydroxide solution, after which the mixture is stirred once more for 5 minutes at room temperature. 7 g of choline chloride, 6 g of sodium ascorbate, 9 g of potassium chloride, 6 g of potassium tricitrate monohydrate, 15 g of magnesium chloride dihydrate and 17 g of trisodium citrate dihydrate were added to 256 g of demineralized water and stirred for about 1 hour at room temperature until all minerals were dissolved or dispersed evenly. The solution containing the macro ingredients was mixed with the solution containing calcium hydroxide and the solution containing the other minerals. This combined solution was stirred for several minutes to ensure even distribution of all components in the solution. The pH of this solution was adjusted to a pH of 4.3 using satis quantum lactic acid. The pH was measured at room temperature with an electrode directly in the solution. 19 g of soy lecithin and 278 g of canola oil were mixed at room temperature and subsequently heated to 60°C in a water bath. The oily mixture was added to the above solution. A pre-emulsion was formed by mixing the oil into the solution using an Ultra Thurrax. The newly formed mixture was homogenized at 60°C with 550+50 bar and cooled to room temperature. The emulsion was preheated to 60°C, heated using DSI to 115°C for 4 seconds and quickly cooled to 60°C. The emulsion was cooled to room temperature. After this treatment, the pH of the emulsion was adjusted to 4.0 using quantum satis lactic acid. The pH was measured at room temperature with an electrode directly in the solution. The dry matter of the product was adjusted by adding demineralized water to obtain the final dry matter required. The emulsion was mixed for about 5 minutes to evenly distribute the water and emulsion. The emulsion was preheated to 60°C using a plate heat exchanger and a UHT treatment provided. The product was filled into vials in a sterile chamber. Example 4 (Example 1 with 100% by weight of unacidified WPI)
[00122] To obtain 20 L of final product, 2.273 g of WPI was dissolved to dissolve a total amount of 2000 g of whey protein in 12.7 kg of demineralized water. This mixture was mixed under gentle agitation to avoid excessive foaming. In this mixture, also 79 g of L-leucine, 6 g of L-isoleucine, 23 g of L-valine, 280 g of GOS syrup (45% pure weight/weight), 15 g of inulin fiber source (97 % pure weight/weight), 31 g of low viscosity pectin source (90% pure weight/weight), 80 g of high methoxy pectin source (35% pure weight/weight) and 505 g of sucrose were dissolved . The mixture was stirred for about 2 hours at room temperature until all macronutrients were evenly dissolved or dispersed. 49 g of calcium hydroxide was added to 715 g of demineralized water and stirred with a stirring rod for 5 minutes. 92 g of citric acid monohydrate were added to the calcium hydroxide solution, after which the mixture is stirred once more for 5 minutes at room temperature. 7 g of choline chloride, 6 g of sodium ascorbate, 11 g of trisodium citrate dihydrate, 26 g of magnesium hydrogen phosphate trihydrate, 35 g of calcium pentaerythritol triphosphate and 32 g of calcium chloride were added to 583 g of water demineralized and stirred for about 1 hour at room temperature until all minerals were dissolved or evenly dispersed. The solution containing the macro ingredients was mixed with the solution containing calcium hydroxide and the solution containing the other minerals. This combined solution was stirred for several minutes to ensure even distribution of all components in the solution. The pH of this solution was adjusted to a pH of 4.9 using quantum satis lactic acid. The pH was measured at room temperature with an electrode directly in the solution. 19 g of soy lecithin and 278 g of canola oil were mixed at room temperature and subsequently heated to 60°C in a water bath. The oily mixture was added to the above solution. A pre-emulsion was formed by mixing the oil into the solution using an Ultra Thurrax. The newly formed mixture was homogenized at 60°C with 550+50 bar and cooled to room temperature. The emulsion was preheated to 60°C, heated using DSI to 110°C for 4 seconds and quickly cooled to 60°C. The emulsion was cooled to room temperature. After this treatment, the pH of the emulsion was adjusted to 4.0 using quantum satis lactic acid. The pH was measured at room temperature with an electrode directly in the solution. The dry matter of the product was adjusted by adding demineralized water to obtain the final dry matter required. The emulsion was mixed for about 5 minutes to evenly distribute the water and emulsion. The emulsion was preheated to 60°C using a plate heat exchanger and a UHT treatment provided. The product was filled into vials in a sterile chamber. Example 5 (Example 1 with 40% by weight of acidified WPI and 60% by weight of non-acidified WPI)
[00123] To obtain the final 20 L product 1.364 g of WPI and 941 g of pre-acidified WPI were dissolved to dissolve a total amount of 2000 g of whey protein in 12.6 kg of demineralized water. This mixture was mixed under gentle agitation to avoid excessive foaming. In this mixture, also 79 g of L-leucine, 6 g of L-isoleucine, 23 g of L-valine, 280 g of GOS syrup (45% pure weight/weight), 15 g of inulin fiber source (97 % pure weight/weight), 31 g of low viscosity pectin source (90% pure weight/weight), 80 g of high methoxy pectin source (35% pure weight/weight) and 505 g of sucrose were dissolved . The mixture was stirred for about 2 hours at room temperature until all macronutrients were evenly dissolved or dispersed. 86 g of calcium hydroxide was added to 1.265 g of demineralized water and stirred with a stirring rod for 5 minutes. 162 g of citric acid monohydrate were added to the calcium hydroxide solution, after which the mixture is stirred once more for 5 minutes at room temperature. 7 g of choline chloride, 6 g of sodium ascorbate, 9 g of tripotassium citrate monohydrate, 30 g of magnesium chloride hexahydrate, 25 g of trisodium citrate and 25 g of calcium chloride were added to 438 g of demineralized water and stirred for about 1 hour at room temperature until all minerals were dissolved or evenly dispersed. The solution containing the macro ingredients was mixed with the solution containing calcium hydroxide and the solution containing the other minerals. This combined solution was stirred for several minutes to ensure even distribution of all components in the solution. The pH of this solution was adjusted to a pH of 4.9 using quantum satis lactic acid. The pH was measured at room temperature with an electrode directly in the solution. 19 g of soy lecithin and 278 g of canola oil were mixed at room temperature and subsequently heated to 60°C in a water bath. The oily mixture was added to the above solution. A pre-emulsion was formed by mixing the oil into the solution using an Ultra Thurrax. The newly formed mixture was homogenized at 60°C with 550+50 bar and cooled to room temperature. The emulsion was preheated to 60°C, heated using DSI to 110°C for 4 seconds and quickly cooled to 60°C. The emulsion was cooled to room temperature. After this treatment, the pH of the emulsion was adjusted to 4.0 using quantum satis lactic acid. The pH was measured at room temperature with an electrode directly in the solution. The dry matter of the product was adjusted by adding demineralized water to obtain the final dry matter required. The emulsion was mixed for about 5 minutes to evenly distribute the water and emulsion. The emulsion was preheated to 60°C using a plate heat exchanger and a UHT treatment provided. The product was filled into vials in a sterile chamber. Example 6 (Example 1, with 116 g/l of serum and 400 mg/100 ml of Ca)
[00124] To obtain 20 L of final product, 1.055 g of WPI and 1.638 g of pre-acidified WPI were dissolved to dissolve a total amount of 2.320 g of whey protein in 12.1 kg of demineralized water. This mixture was mixed under gentle agitation to avoid excessive foaming. In this mixture, also 8 g of carotenoid blend, 216 g of L-leucine, 444 g of GOS syrup (45% pure weight/weight), 23 g of inulin fiber source (97% pure weight/weight), 49 g of low viscosity pectin source (90% w/w pure) and 60 g of high methoxy pectin source (35% w/w pure) and 1.088 g of sucrose were dissolved. The mixture was stirred for about 2 hours at room temperature until all macronutrients were evenly dissolved or dispersed. 149 g of calcium hydroxide was added to 2.191 g of demineralized water and stirred with a stirring rod for 5 minutes. 281 g of citric acid monohydrate were added to the calcium hydroxide solution, after which the mixture is stirred once more for 5 minutes at room temperature. 12 g of choline chloride, 9 g of sodium ascorbate, 42 g of magnesium hydrogen phosphate dihydrate, 33 g of sodium chloride and 33 g of potassium dihydrogen phosphate were added to 641 g of demineralized water and stirred for ca. 1 hour at room temperature until all minerals are dissolved or evenly dispersed. The solution containing the macro ingredients was mixed with the solution containing calcium hydroxide and the solution containing the other minerals. This combined solution was stirred for several minutes to ensure even distribution of all components in the solution. The pH of this solution was adjusted to a pH of 4.3 using satis quantum lactic acid. The pH was measured at room temperature with an electrode directly in the solution. 25 g of soy lecithin and 372 g of canola oil were mixed at room temperature and subsequently heated to 60°C in a water bath. The oily mixture was added to the above solution. A pre-emulsion was formed by mixing the oil into the solution using an Ultra Thurrax. The newly formed mixture was homogenized at 60°C with 550+50 bar and cooled to room temperature. The emulsion was preheated to 60°C, heated using DSI to 115°C for 4 seconds and quickly cooled to 60°C. The emulsion was cooled to room temperature. After this treatment, the pH of the emulsion was adjusted to 4.0 using quantum satis lactic acid. The pH was measured at room temperature with an electrode directly in the solution. The dry matter of the product was adjusted by adding demineralized water to obtain the final dry matter required. The emulsion was mixed for about 5 minutes to evenly distribute the water and emulsion. The emulsion was preheated to 60°C using a plate heat exchanger and a UHT treatment provided. The product was filled into vials in a sterile chamber. Example 7 (Example 1, with 160 g/l of serum and 400 mg/100 ml of Ca)
[00125] To obtain the final 20 L product 3546 g of WPI were dissolved to dissolve a total amount of 3200 g of whey protein in 13.0 kg of demineralized water. This mixture was mixed under gentle agitation to avoid excessive foaming. In this mixture, also 80 g of L-leucine, 18 g of L-isoleucine, 10 g of L-valine, 444 g of GOS syrup (45% pure weight/weight) and 23 grams of inulin fiber source (97 % pure weight/weight) were dissolved. After all the ingredients had been dissolved or evenly dispersed, the following ingredients were dissolved in this mixture: 51 g of low viscosity pectin source (90% pure weight/weight), 80 g of high methoxy pectin source (35 % pure weight/weight) and 963 g of sucrose. The mixture was stirred for about 2 hours at room temperature until all macronutrients were evenly dissolved or dispersed. 82 g of calcium hydroxide was added to 1210 g of demineralized water and stirred with a stirring rod for 5 minutes. 155 g of citric acid monohydrate were added to the calcium hydroxide solution, after which the mixture is stirred once more for 5 minutes at room temperature. 12 g of choline chloride, 9 g of sodium ascorbate, 36 g of magnesium hydrogen phosphate dihydrate, 42 g of calcium pentaerythritol triphosphate, 5 g of potassium chloride and 10 g of tripotassium citrate monohydrate were added to 825 g of demineralized water and stirred for about 1 hour at room temperature until all minerals were dissolved or evenly dispersed. The solution containing the macro ingredients was mixed with the solution containing calcium hydroxide and the solution containing the other minerals. This combined solution was stirred for several minutes to ensure even distribution of all components in the solution. The pH of this solution was adjusted to a pH of 4.3 using satis quantum lactic acid. The pH was measured at room temperature with an electrode directly in the solution. 30 g of soy lecithin and 442 g of canola oil were mixed at room temperature and subsequently heated to 60°C in a water bath. The oily mixture was added to the above solution. A pre-emulsion was formed by mixing the oil into the solution using an Ultra Thurrax. The newly formed mixture was homogenized at 20°C with 550+50 bar and cooled to room temperature. The emulsion was heated using DSI to 115°C for 4 seconds and quickly cooled to 60°C. The emulsion was cooled to room temperature. After this treatment, the pH of the emulsion was adjusted to 4.0 using quantum satis lactic acid. The pH was measured at room temperature with an electrode directly in the solution. The dry matter of the product was adjusted by adding demineralized water to obtain the final dry matter required. The emulsion was mixed for about 5 minutes to evenly distribute the water and emulsion. The emulsion was preheated to 60°C using a plate heat exchanger and a UHT treatment provided. The product was filled into vials in a sterile chamber. Example 8 (Example 1, with greater amount of fat)
[00126] To obtain 20 L of final product, 909 g of WPI and 1.412 g of pre-acidified WPI were dissolved to dissolve a total amount of 2000 g of whey protein in 12.7 kg of demineralized water. This mixture was mixed under gentle agitation to avoid excessive foaming. In this mixture, also 8 g of carotenoid mixture, 79 g of L-leucine, 6 g of L-isoleucine, 23 g of L-valine, 280 g of GOS syrup (45% pure weight/weight), 14 g of inulin fiber source (97% pure weight/weight), 31 g low viscosity pectin source (90% pure weight/weight) and 60 g high methoxy pectin source (35% pure weight/weight) and 2.738 g of sucrose were dissolved. The mixture was stirred for about 2 hours at room temperature until all macronutrients were evenly dissolved or dispersed. 91 g of calcium hydroxide was added to 1.346 g of demineralized water and stirred with a stirring rod for 5 minutes. 173 g of citric acid monohydrate were added to the calcium hydroxide solution, after which the mixture is stirred once more for 5 minutes at room temperature. 7 g of choline chloride, 6 g of sodium ascorbate, 9 g of potassium chloride, 11 g of tri-potassium citrate monohydrate, 30 g of magnesium chloride dihydrate and 34 g of trisodium citrate dihydrate were added to 492 g of demineralized water and stirred for about 1 hour at room temperature until all minerals were dissolved or dispersed evenly. The solution containing the macro ingredients was mixed with the solution containing calcium hydroxide and the solution containing the other minerals. This combined solution was stirred for several minutes to ensure even distribution of all components in the solution. The pH of this solution was adjusted to a pH of 4.3 using satis quantum lactic acid. The pH was measured at room temperature with an electrode directly in the solution. 80 g of soy lecithin and 1120 g of canola oil were mixed at room temperature and subsequently heated to 60°C in a water bath. The oily mixture was added to the above solution. A pre-emulsion was formed by mixing the oil into the solution using an Ultra Thurrax. The newly formed mixture was homogenized at 60°C with 550+50 bar and cooled to room temperature. The emulsion was preheated to 60°C, heated using DSI to 115°C for 4 seconds and quickly cooled to 60°C. The emulsion was cooled to room temperature. After this treatment, the pH of the emulsion was adjusted to 4.0 using quantum satis lactic acid. The pH was measured at room temperature with an electrode directly in the solution. The dry matter of the product was adjusted by adding demineralized water to obtain the final dry matter required. The emulsion was mixed for about 5 minutes to evenly distribute the water and emulsion. The emulsion was preheated to 60°C using a plate heat exchanger and a UHT treatment provided. The product was filled into vials in a sterile chamber. Example 9 (Example 1, with pH = 3.7 during DSI)
[00127] To obtain 20 L of final product, 909 g of WPI and 1.412 g of pre-acidified WPI were dissolved to dissolve a total amount of 2000 g of whey protein in 13.5 kg of demineralized water. This mixture was mixed under gentle agitation to avoid excessive foaming. In this mixture, also 8 g of carotenoid mixture, 79 g of L-leucine, 6 g of L-isoleucine, 23 g of L-valine, 280 g of GOS syrup (45% pure weight/weight), 14 g of inulin fiber source (97% pure weight/weight), 31 g low viscosity pectin source (90% pure weight/weight) and 60 g high methoxy pectin source (35% pure weight/weight) and 505 g of sucrose was dissolved. The mixture was stirred for about 2 hours at room temperature until all macronutrients were evenly dissolved or dispersed. 91 g of calcium hydroxide was added to 1.346 g of demineralized water and stirred with a stirring rod for 5 minutes. 173 g of citric acid monohydrate were added to the calcium hydroxide solution, after which the mixture is stirred once more for 5 minutes at room temperature. 7 g of choline chloride, 6 g of sodium ascorbate, 9 g of potassium chloride, 11 g of tri-potassium citrate monohydrate, 30 g of magnesium chloride dihydrate and 34 g of trisodium citrate dihydrate were added to 492 g of demineralized water and stirred for about 1 hour at room temperature until all minerals were dissolved or dispersed evenly. The solution containing the macro ingredients was mixed with the solution containing calcium hydroxide and the solution containing the other minerals. This combined solution was stirred for several minutes to ensure even distribution of all components in the solution. The pH of this solution was adjusted to a pH of 3.7 using satis quantum lactic acid. The pH was measured at room temperature with an electrode directly in the solution. 19 g of soy lecithin and 278 g of canola oil were mixed at room temperature and subsequently heated to 60°C in a water bath. The oily mixture was added to the above solution. A pre-emulsion was formed by mixing the oil into the solution using an Ultra Thurrax. The newly formed mixture was homogenized at 60°C with 550+50 bar and cooled to room temperature. The emulsion was preheated to 60°C, heated using DSI to 115°C for 4 seconds and quickly cooled to 60°C. The emulsion was cooled to room temperature. After this treatment, the pH of the emulsion was adjusted to 4.0 using a quantum satis potassium hydroxide solution. The pH was measured at room temperature with an electrode directly in the solution. The dry matter of the product was adjusted by adding demineralized water to obtain the final dry matter required. The emulsion was mixed for about 5 minutes to evenly distribute the water and emulsion. The emulsion was preheated to 60°C using a plate heat exchanger and a UHT treatment provided. The product was filled into vials in a sterile chamber. Example 10 (Example 1, with pH = 4.9 during DSI)
[00128] To obtain 20 L of final product, 909 g of WPI and 1.412 g of pre-acidified WPI were dissolved to dissolve a total amount of 2000 g of whey protein 13.5 kg of demineralized water. This mixture was mixed under gentle agitation to avoid excessive foaming. In this mixture, also 8 g of carotenoid mixture, 79 g of L-leucine, 6 g of L-isoleucine, 23 g of L-valine, 280 g of GOS syrup (45% pure weight/weight), 14 g of inulin fiber source (97% pure weight/weight), 31 g low viscosity pectin source (90% pure weight/weight) and 60 g high methoxy pectin source (35% pure weight/weight) and 505 g of sucrose was dissolved. The mixture was stirred for about 2 hours at room temperature until all macronutrients were evenly dissolved or dispersed. 91 g of calcium hydroxide was added to 1.346 g of demineralized water and stirred with a stirring rod for 5 minutes. 173 g of citric acid monohydrate were added to the calcium hydroxide solution, after which the mixture is stirred once more for 5 minutes at room temperature. 7 g of choline chloride, 6 g of sodium ascorbate, 9 g of potassium chloride, 11 g of tri-potassium citrate monohydrate, 30 g of magnesium chloride dihydrate and 34 g of trisodium citrate dihydrate were added to 492 g of demineralized water and stirred for about 1 hour at room temperature until all minerals were dissolved or dispersed evenly. The solution containing the macro ingredients was mixed with the solution containing calcium hydroxide and the solution containing the other minerals. This combined solution was stirred for several minutes to ensure even distribution of all components in the solution. The pH of this solution was adjusted to a pH of 4.9 using a quantum satis potassium hydroxide solution. The pH was measured at room temperature with an electrode directly in the solution. 19 g of soy lecithin and 278 g of canola oil were mixed at room temperature and subsequently heated to 60°C in a water bath. The oily mixture was added to the above solution. A pre-emulsion was formed by mixing the oil into the solution using an Ultra Thurrax. The newly formed mixture was homogenized at 60°C with 550+50 bar and cooled to room temperature. The emulsion was preheated to 60°C, heated using DSI to 115°C for 4 seconds and quickly cooled to 60°C. The emulsion was cooled to room temperature. After this treatment, the pH of the emulsion was adjusted to 4.0 using quantum satis lactic acid. The pH was measured at room temperature with an electrode directly in the solution. The dry matter of the product was adjusted by adding demineralized water to obtain the final dry matter required. The emulsion was mixed for about 5 minutes to evenly distribute the water and emulsion. The emulsion was preheated to 60°C using a plate heat exchanger and a UHT treatment provided. The product was filled into vials in a sterile chamber.
[00129] The results are summarized in Table 1.
Example 11 (As in Example 1, with homogenization after DSI treatment)
[00130] To obtain 20 L of final product, 909 g of WPI and 1.412 g of pre-acidified WPI were dissolved to dissolve a total amount of 2000 g of whey protein in 11.7 kg of tap water. This mixture was mixed under gentle agitation to avoid excessive foaming. In this mixture, also 79 g of L-leucine, 6 g of L-isoleucine, 23 g of L-valine, 280 g of GOS syrup (45% pure weight/weight) and 14 g of inulin fiber source (97 % pure weight/weight) were dissolved. The mixture was stirred for about 2 hours at room temperature until all macronutrients were evenly dissolved or dispersed. 8 g of carotenoid mixture was dissolved in 75 g of tap water, stirred for 5 minutes at room temperature and added to the macronutrient mixture. 85 g of calcium hydroxide was added to 1.255 g of tap water and stirred with a stirring rod for 1 minute. 161 g of citric acid monohydrate were added to the calcium hydroxide solution, after which the mixture is stirred again for 3 minutes at room temperature. 7 g of choline chloride, 8 g of calcium chloride dihydrate, 24 g of tri-potassium citrate monohydrate, 29 g of magnesium chloride dihydrate and 30 g of trisodium citrate dihydrate were added to 490 g of tap water and stirred during about 1 hour at room temperature until all minerals are dissolved or dispersed evenly. 5 g of mineral premix and 5 g of trisodium citrate dihydrate were added to 90 g of tap water and stirred for about 1 hour at room temperature until all minerals were dissolved or dispersed evenly. The solution containing the macro ingredients was mixed with the solution containing calcium hydroxide and the other two solutions containing minerals. This combined solution was stirred for several minutes to ensure even distribution of all components in the solution. 45 g of low viscosity pectin source (90% pure wt/wt), 80 g high methoxy pectin source (35% pure wt/wt) and 430 g sucrose are dry blended and added to the above solution described under gentle agitation at room temperature. The pH of this solution was adjusted to a pH of 4.3 using satis quantum lactic acid. The pH was measured at room temperature with an electrode directly in the solution. 19 g of soy lecithin and 278 g of canola oil were mixed at room temperature and subsequently heated to 60°C in a water bath. The oily mixture was added to the above solution. A pre-emulsion was formed by mixing the oil into the solution using an Ultra Thurrax. The newly formed mixture was preheated to 60°C, heated using DSI to 110°C for 4 seconds, quickly cooled to 60°C and homogenized at 60°C with 550+50 bar. The emulsion was cooled to room temperature. After this heat treatment, the pH of the emulsion was adjusted to 4.0 using quantum satis lactic acid. The pH was measured at room temperature with an electrode directly in the solution. The dry matter of the product was adjusted by adding running water to obtain the final dry matter required. The emulsion was mixed for about 5 minutes to evenly distribute the water and emulsion. 5 g of sodium ascorbate was added to the emulsion under gentle agitation. The emulsion was preheated to 60°C using a tube heat exchanger and a UHT treatment provided. The product was filled into vials in a sterile chamber. Example 12 (As in Example 1, no DSI treatment)
[00131] To obtain 20 L of final product, 909 g of WPI and 1.412 g of pre-acidified WPI were dissolved to dissolve a total amount of 2000 g of whey protein in 12.7 kg of demineralized water. This mixture was mixed under gentle agitation to avoid excessive foaming. In this mixture, also 8 g of carotenoid mixture, 79 g of L-leucine, 6 g of L-isoleucine, 23 g of L-valine, 280 g of GOS syrup (45% pure weight/weight), 14 g of inulin fiber source (97% pure weight/weight), 31 g low viscosity pectin source (90% pure weight/weight) and 60 g high methoxy pectin source (35% pure weight/weight) and 505 g of sucrose was dissolved. The mixture was stirred for about 2 hours at room temperature until all macronutrients were evenly dissolved or dispersed. 91 g of calcium hydroxide was added to 1.346 g of demineralized water and stirred with a stirring rod for 5 minutes. 173 g of citric acid monohydrate were added to the calcium hydroxide solution, after which the mixture is stirred once more for 5 minutes at room temperature. 7 g of choline chloride, 6 g of sodium ascorbate, 9 g of potassium chloride, 11 g of tri-potassium citrate monohydrate, 30 g of magnesium chloride dihydrate and 34 g of trisodium citrate dihydrate were added to 492 g of demineralized water and stirred for about 1 hour at room temperature until all minerals were dissolved or dispersed evenly. The solution containing the macro ingredients was mixed with the solution containing calcium hydroxide and the solution containing the other minerals. This combined solution was stirred for several minutes to ensure even distribution of all components in the solution. The pH of this solution was adjusted to a pH of 4.3 using satis quantum lactic acid. The pH was measured at room temperature with an electrode directly in the solution. 19 g of soy lecithin and 278 g of canola oil were mixed at room temperature and subsequently heated to 60°C in a water bath. The oily mixture was added to the above solution. A pre-emulsion was formed by mixing the oil into the solution using an Ultra Thurrax. The newly formed mixture was homogenized at 60°C with 550+50 bar and cooled to room temperature. The pH of the emulsion was adjusted to 4.0 using satis quantum lactic acid. The pH was measured at room temperature with an electrode directly in the solution. The dry matter of the product was adjusted by adding demineralized water to obtain the final dry matter required. The emulsion was mixed for about 5 minutes to evenly distribute the water and emulsion. The emulsion was preheated to 60°C using a plate heat exchanger and a UHT treatment provided. The product was filled into vials in a sterile chamber. Example 13 (Comparative as in Example 1, but with less than 100 mg/100 ml of divalent cations)
[00132] To obtain 20 L of final product, 909 g of WPI and 1.412 g of pre-acidified WPI were dissolved to dissolve a total amount of 2000 g of whey protein in 12.7 kg of demineralized water. Before adding the proteins, 8 g of the carotenoid mixture was added to the water. This mixture was mixed under gentle agitation to avoid excessive foaming. In this mixture, also 79 g of L-leucine, 6 g of L-isoleucine, 23 g of L-valine, 280 g of GOS syrup (45% pure weight/weight), 15 g of inulin fiber source (97 % pure weight/weight), 31 g of low viscosity pectin source (90% pure weight/weight) and 60 g of high methoxy pectin source (35% pure weight/weight) and 505 g of sucrose were dissolved . The mixture was stirred for about 2 hours at room temperature until all macronutrients were evenly dissolved or dispersed. The pH of this solution was adjusted to a pH of 4.3 using satis quantum lactic acid. The pH was measured at room temperature with an electrode directly in the solution. 19 g of soy lecithin and 278 g of canola oil were mixed at room temperature and subsequently heated to 60°C in a water bath. The oily mixture was added to the above solution. A pre-emulsion was formed by mixing the oil into the solution using an Ultra Thurrax. The newly formed mixture was homogenized at 60°C with 550+50 bar and cooled to room temperature. The emulsion was preheated to 60°C, heated using DSI to 115°C for 4 seconds and quickly cooled to 60°C. The emulsion was cooled to room temperature. After this treatment, the pH of the emulsion was adjusted to 4.0 using quantum satis lactic acid. The pH was measured at room temperature with an electrode directly in the solution. The dry matter of the product was adjusted by adding demineralized water to obtain the final dry matter required. The emulsion was mixed for about 5 minutes to evenly distribute the water and emulsion. The emulsion was preheated to 60°C using a plate heat exchanger and a UHT treatment provided. The product was filled into vials in a sterile chamber. The results are summarized in Table 2. Table 2: Summary of Examples 11-13

Viscosity is measured at 20°C at a shear rate of 100 s-1 Astringency: low astringency (+ +), astringent (0), very astringent (--) Sandiness: low grit (+ +), gritty (0 ), very sandy (--) Example 14: Preparation of a composition to serve with a spoon
[00133] To obtain 20 L of final product, 909 g of WPI and 1.412 g of pre-acidified WPI, giving a total of 2000 g of whey protein, were dissolved in 12.6 kg of demineralized water. This mixture was mixed under gentle agitation to avoid excessive foaming. In this mixture, also 8 g of carotenoid mixture, 79 g of L-leucine, 6 g of L-isoleucine, 23 g of L-valine, 280 g of GOS syrup (45% pure weight/weight), 14 g of inulin fiber source (97% pure weight/weight), 31 g low viscosity pectin source (90% pure weight/weight), 200 g high methoxy pectin source (35% pure weight/weight) and 505 g of sucrose was dissolved. The mixture was stirred for about 2 hours at room temperature until all macronutrients were evenly dissolved or dispersed. 91 g of calcium hydroxide was added to 1.346 g of demineralized water and stirred with a stirring rod for 5 minutes. 173 g of citric acid monohydrate were added to the calcium hydroxide solution, after which the mixture is stirred once more for 5 minutes at room temperature. 7 g of choline chloride, 6 g of sodium ascorbate, 9 g of potassium chloride, 11 g of tri-potassium citrate monohydrate, 30 g of magnesium chloride dihydrate and 34 g of trisodium citrate dihydrate were added to 492 g of demineralized water and stirred for about 1 hour at room temperature until all minerals were dissolved or dispersed evenly. The solution containing the macro ingredients was mixed with the solution containing calcium hydroxide and the solution containing the other minerals. This combined solution was stirred for several minutes to ensure even distribution of all components in the solution. The pH of this solution was adjusted to a pH of 4.0 using satis quantum lactic acid. The pH was measured at room temperature with an electrode directly in the solution. 19 g of soy lecithin and 278 g of canola oil were mixed at room temperature and subsequently heated to 60°C in a water bath. The oily mixture was added to the above solution. A pre-emulsion was formed by mixing the oil into the solution using an Ultra Thurrax. The newly formed mixture was homogenized at 60°C with 550+50 bar and cooled to room temperature. The emulsion was preheated to 60°C, heated using DSI to 115°C for 4 seconds and quickly cooled to 60°C. The emulsion was cooled to room temperature. After this treatment, the pH of the emulsion was checked and if necessary adjusted to 4.0 using quantum satis lactic acid. The pH was measured at room temperature with an electrode directly in the solution. The dry matter of the product was adjusted by adding demineralized water to obtain the final dry matter required. The emulsion was mixed for about 5 minutes to evenly distribute the water and emulsion. The emulsion was preheated to 60°C using a plate heat exchanger and a UHT treatment provided. The product was filled into plastic cups in a sterile chamber. Example 15: Preparation of a composition to serve with a spoon
[00134] To obtain 20 L of final product, 909 g of WPI and 1.412 g of pre-acidified WPI, giving a total amount of 2000 g of whey protein, were dissolved in 12.5 kg of demineralized water. This mixture was mixed under gentle agitation to avoid excessive foaming. In this mixture, also 8 g of carotenoid mixture, 79 g of L-leucine, 6 g of L-isoleucine, 23 g of L-valine, 280 g of GOS syrup (45% pure weight/weight), 14 g of inulin fiber source (97% pure weight/weight), 31 g of low viscosity pectin source (90% pure weight/weight) and 60 g of highly methoxy pectin source (35% pure weight/weight), 200 g of modified starch (E1442) and 505 g of sucrose were dissolved. The mixture was stirred for about 2 hours at room temperature until all macronutrients were evenly dissolved or dispersed. 91 g of calcium hydroxide was added to 1.346 g of demineralized water and stirred with a stirring rod for 5 minutes. 173 g of citric acid monohydrate were added to the calcium hydroxide solution, after which the mixture is stirred once more for 5 minutes at room temperature. 7 g of choline chloride, 6 g of sodium ascorbate, 9 g of potassium chloride, 11 g of tri-potassium citrate monohydrate, 30 g of magnesium chloride dihydrate and 34 g of trisodium citrate dihydrate were added to 492 g of demineralized water and stirred for about 1 hour at room temperature until all minerals were dissolved or dispersed evenly. The solution containing the macro ingredients was mixed with the solution containing calcium hydroxide and the solution containing the other minerals. This combined solution was stirred for several minutes to ensure even distribution of all components in the solution. The pH of this solution was adjusted to a pH of 4.0 using satis quantum lactic acid. The pH was measured at room temperature with an electrode directly in the solution. 19 g of soy lecithin and 278 g of canola oil were mixed at room temperature and subsequently heated to 60°C in a water bath. The oily mixture was added to the above solution. A pre-emulsion was formed by mixing the oil into the solution using an Ultra Thurrax. The newly formed mixture was homogenized at 60°C with 550+50 bar and cooled to room temperature. The emulsion was preheated to 60°C, heated using DSI to 115°C for 4 seconds and quickly cooled to 60°C. The emulsion was cooled to room temperature. After this treatment, the pH of the emulsion was checked and if necessary adjusted to 4.0 using quantum satis lactic acid. The pH was measured at room temperature with an electrode directly in the solution. The dry matter of the product was adjusted by adding demineralized water to obtain the final dry matter required. The emulsion was mixed for about 5 minutes to evenly distribute the water and emulsion. The emulsion was preheated to 60°C using a plate heat exchanger and a UHT treatment provided. Product was filled into plastic cups in a sterile chamber.

2. NUTRITIONAL COMPOSITIONS
[00135] The nutritional composition according to the invention below is suitable for the prevention or treatment of a disease in an elderly mammal, which involves muscle protein synthesis. Table 3: Example of a liquid food composition for drinking (200 ml serving)


EXEMPLIFICATION MODALITIES OF THE INVENTION
[00136] Modality (A): A sterilized liquid acidic enteral nutritional composition comprising, per 100 ml of said composition, from 9 to 20 g of unhydrolyzed globular protein, fat and at least 100 mg of divalent metal cations and having a pH ranging between 3 and 5 .
[00137] Modality (B): The nutritional composition according to the preceding modality, wherein the pH ranges between 3.7 and 4.3, preferably is equal to about 4.0.
[00138] Modality (C): The nutritional composition according to any of the preceding modalities, wherein the amount of divalent metal cations varies between 100 and 600 mg per 100 ml.
[00139] Modality (D): The nutritional composition according to any of the preceding modalities, wherein the amount of unhydrolyzed globular proteins ranges between 4 and 16 g, preferably equal to about 10 g per 100 ml of the composition .
[00140] Modality (E): The nutritional composition according to any of the preceding embodiments, wherein the divalent metal cations are chosen from the group consisting of Ca, Mg and any mixture thereof, preferably is Ca.
[00141] Modality (F): The nutritional composition according to any of the preceding modalities, wherein the globular protein is selected from the group consisting of whey protein, pea protein, soy protein and any mixture thereof .
[00142] Modality (G): The nutritional composition according to modality 6, wherein the whey protein source is selected from the group consisting of whey protein concentrate (WPC), whey protein isolate. whey (WPI) and any mixture thereof.
Modality (H): The nutritional composition according to any of the preceding embodiments, wherein the amount of unhydrolyzed globular protein is at least 85% by weight of the total proteinaceous matter in the composition.
Modality (I): The nutritional composition according to any of the preceding embodiments, further comprising a non-globular protein, a hydrolyzed protein, an oligopeptide, a peptide or a free amino acid.
[00145] Modality (J): The nutritional composition according to modality 9, wherein the non-globular protein is selected from the group of casein, caseinate, micellar casein isolate and any mixture thereof.
Modality (K): The nutritional composition according to modality 9, wherein the free amino acid is selected from the group of branched chain amino acids, in particular L-leucine.
[00147] Modality (L): The nutritional composition according to any of the preceding modalities, wherein said fat provides from 15 to 65% of the total amount of energy in the composition.
[00148] Modality (M): The nutritional composition according to any of the preceding modalities, further comprising carbohydrates, said carbohydrates providing between 20 to 60% of the amount of total energy in the composition.
Modality (N): The nutritional composition according to any of the preceding embodiments, wherein the viscosity of the composition is less than 200 mPa.s, preferably less than 100 mPa.s, measured at 20°C in one 100 s-1 shear rate.
[00150] Modality (O): The nutritional composition according to any of the preceding embodiments, in a container with a unit dosage of about 200 ml.
[00151] Modality (P): Nutritional composition according to any of the preceding modalities, comprising: a) about 10 g of non-hydrolyzed whey protein per 100 ml of the composition, said protein providing about 56% of the amount of total energy of the composition; b) fat, which provides about 18% of the total amount of energy in the composition; c) optionally carbohydrates, which provide about 23% of the total energy amount of the composition, d) about 250 mg per 100 ml Ca and about 19 mg Mg per 100 ml; and e) having a pH of about 4.
[00152] Modality (Q): The use of a nutritional composition according to any of the preceding modalities for the manufacture of a nutritionally complete food.
[00153] Modality (R): The nutritional composition according to any of the preceding modalities for use in the nutritional management of a person in need thereof.
[00154] Modality (S): Nutritional composition according to modality (R), in which the person is an elderly person, a person who is in an unhealthy state, a person who is recovering from an unhealthy state, a person who is malnourished, a sportsman or an active elderly person.
[00155] Modality (T): The nutritional composition according to modality (R) or (S) for the prevention or treatment of a disease or condition involving muscle decline in a mammal, in particular to treat sarcopenia.
[00156] Modality (U): A method for preparing a liquid sterilized enteral acid composition comprising, per 100 ml, from 9 to 20 g of unhydrolyzed globular proteins, fats and at least 100 mg of divalent metal cations and having a pH ranging between 3 and 5, according to any one of the modalities (A) to (P), comprising a step in which at least the unhydrolyzed globular proteins are subjected to a homogenization step, followed by direct steam injection (Direct Steam Injection - DSI), maintenance at specific values, such as maintaining a temperature between 100 and 140°C for a retention time of about 0.5 to 10 seconds, followed by a sterilization step.
[00157] Modality (V): Process according to modality (L), comprising the consecutive steps of: a) preparation of an aqueous solution containing amounts of divalent metal cations, in particular calcium and magnesium, non-hydrolyzed globular proteins and fat, so that said liquid sterilized acidic enteral composition comprises, per 100 ml of said composition, from 9 to 20 g of unhydrolyzed globular proteins, fat and at least 100 mg of divalent metal cations and having a pH ranging from 3 and 5; b) homogenization of the resulting solution essentially obtained in step a); c) subjecting the resulting solution essentially obtained from step b) to a direct steam injection process at a holding temperature of 100 to 140°C for a holding time of about 0.5 to 10 seconds; and d) subjecting the resulting solution obtained essentially from step c) to a sterilization treatment.
[00158] Modality (W): Liquid sterilized acidic enteral composition comprising, per 100 ml, from 9 to 20 g of unhydrolyzed globular proteins, fats and at least 100 mg of divalent metal cations and having a pH ranging between 3 and 5 , obtainable through a method according to modality (U) or (V).

权利要求:
Claims (20)
[0001]
1. Method for the preparation of a sterile liquid or semi-solid acidic enteral composition comprising, per 100 ml of said composition, from 9 to 20 g of unhydrolyzed globular proteins, wherein the globular proteins are selected from the group consisting of protein. whey, pea protein, soy protein and any mixture thereof, the composition further comprising fat and at least 100 mg of divalent metal cations and having a pH ranging between 3 and 5, wherein said method comprises a step in which at least the unhydrolyzed globular proteins are subjected to a homogenization step, characterized in that it is followed by direct injection of DSI steam at a retention temperature of 100 to 140°C for a retention time of 0.5 to 10 seconds.
[0002]
2. Method according to claim 1, characterized in that the pH varies between 3.7 and 4.3.
[0003]
3. Method according to claim 1 or 2, characterized in that it further comprises a stabilizing polysaccharide selected from the group consisting of pectin of high methoxy content, carboxy methyl cellulose and combinations thereof.
[0004]
4. Method according to any one of claims 1 to 3, characterized in that the amount of divalent metal cations varies between 100 and 600 mg per 100 mL.
[0005]
5. Method according to any one of claims 1 to 4, characterized in that the amount of unhydrolyzed globular proteins varies between 9 and 16 g.
[0006]
6. Method according to any one of claims 1 to 5, characterized in that the divalent metal cations are chosen from the group consisting of Ca, Mg and any mixture thereof.
[0007]
7. Method according to claim 6, characterized in that the divalent metal cation is Ca.
[0008]
8. Method according to any one of claims 1 to 7, characterized in that the globular proteins comprise whey protein and the whey protein source is selected from the group consisting of whey protein concentrate of WPC milk, WPI whey protein isolate and any mixture thereof.
[0009]
9. Method according to any one of claims 1 to 8, characterized in that the amount of non-hydrolyzed globular proteins is at least 85% by weight of the total proteinaceous matter in the composition.
[0010]
10. Method according to any one of claims 1 to 9, characterized in that the enteral composition further comprises free amino acid, preferably branched-chain free amino acids.
[0011]
11. Method according to any one of claims 1 to 10, characterized in that the enteral composition further comprises fat, said fat providing 15 to 65% of the amount of total energy in the composition.
[0012]
12. Method according to any one of claims 1 to 11, characterized in that the enteral composition further comprises carbohydrates, said carbohydrates providing between 20 to 60% of the amount of total energy in the composition.
[0013]
13. Method according to any one of claims 1 to 12, characterized in that the composition is a liquid and the viscosity of the composition is less than 100 mPa.s, measured at 20°C at a shear rate of 100 s-1.
[0014]
14. Method according to any one of claims 1 to 13, characterized in that the direct steam injection is followed by a sterilization step.
[0015]
15. Method according to any one of claims 1 to 14, characterized in that it comprises a step in which at least the non-hydrolyzed whey proteins and said polysaccharide together are subjected to homogenization, followed by direct injection of DSI steam.
[0016]
16. Method according to any one of claims 1 to 15, characterized in that it comprises the consecutive steps of: (a) preparation of an aqueous solution containing amounts of divalent metal cations, in particular calcium and magnesium, globular proteins non-hydrolyzed and fat, so that said liquid acidic sterilized enteral composition comprises, per 100 ml of said composition, from 9 to 20 g of non-hydrolyzed globular proteins, fat and at least 100 mg of divalent metal cations and having a pH ranging between 3 and 5; (b) homogenization of the resulting solution essentially obtained in step (a); (c) subjecting the resulting solution essentially obtained by step (b) to a direct steam injection process at a holding temperature of 100 to 140°C for a holding time of 0.5 to 10 seconds.
[0017]
17. Method according to claim 16, characterized in that step (c) is followed by the step of: (d) subjecting the resulting solution obtained by step (c) to a sterilization treatment.
[0018]
18. Method according to any one of claims 1 to 17, characterized in that it is for preparing a semi-solid enteral nutritional composition, said method comprising the steps of adding a thickening or gel-forming agent to the acidic composition sterile liquid enteral and further processing the mixture into a semi-solid final product.
[0019]
19. Method according to any one of claims 1 to 18, characterized in that it is for preparing a semi-solid enteral nutritional composition, said method comprising the steps of adding a thickening or gel-forming agent to the aqueous solution of step (a).
[0020]
20. Use of steam to reduce the astringency and/or grittiness of a sterilized liquid or semi-solid acidic whey protein solution, characterized in that steam is contacted with the whey protein solution through direct injection of steam; wherein the solution is a sterilized, non-hydrolyzed whey protein-based enteral nutritional composition, liquid, acidic or semi-solid, containing divalent metal cations.

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US20140296162A1|2014-10-02|

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PL2651249T3|2020-01-31|

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PT2651249T|2019-10-30|

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CH715997A1|2019-03-25|2020-09-30|Omanda Ag|Protein drink and dosage unit for the administration of L-leucine-enriched whey protein components as food fortification and its production.|

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CN113873900A|2019-05-24|2021-12-31|科舒克拉-格鲁普瓦尔科迎有限公司|Composition comprising inulin and protein|

法律状态:
2018-01-16| B07D| Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]|

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2018-03-27| B15K| Others concerning applications: alteration of classification|Ipc: A23J 3/08 (2006.01), A23L 3/16 (2006.01), A61K 33/ |

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2018-04-03| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2018-06-19| B07G| Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]|

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2019-01-29| B11E| Dismissal acc. art. 34 of ipl - requirements for examination incomplete|

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2019-02-19| B11N| Dismissal: publication cancelled|Free format text: ANULADA A PUBLICACAO CODIGO 11.5 NA RPI NO 2508 DE 29/01/2019 POR TER SIDO INDEVIDA. |

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2019-03-12| B06T| Formal requirements before examination [chapter 6.20 patent gazette]|

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2020-12-01| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|

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2021-04-06| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-05-25| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 16/12/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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NLPCT/NL2010/050866|2010-12-17|

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PCT/NL2010/050866|WO2012081971A1|2010-12-17|2010-12-17|Whey protein composition with a reduced astringency|

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PCT/NL2011/050857|WO2012081982A2|2010-12-17|2011-12-16|Whey protein composition with a reduced astringency|

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