CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and any benefit of U.S. Provisional Application No. 62/040,645, filed August 22, 2014, the content of which is incorporated herein by reference in its entirety.

FIELD

[0002] The general inventive concepts relate to nutritional compositions and more particularly to nutritional compositions that include a rice protein ingredient.

BACKGROUND

[0003] Liquid nutritional compositions typically include balanced amounts of macronutrients (proteins, carbohydrates, and fats) as well as micronutrients and flavorings. For example, nutrition shakes, i.e., non-carbonated liquid nutritional compositions which are intended for oral consumption and therefore have the consistency, flavor, and overall desirable sensory characteristics of common milk shakes, are widely-available consumer products. Examples include the Ensure ^® , Glucerna ^® , Myoplex ^® , and PediaSure ^® line of nutrition shakes available from Abbott Nutrition of Columbus, Ohio, the Muscle Milk ^® line of nutrition shakes available from CytoSport, Inc. of Benicia, California, and the Resource ^® line of health shakes available from Nestle, S.A. of Vevey, Switzerland. Generally, they are made up in the form of oil-in- water emulsions having the consistency of common milk shakes.

[0004] The proteins found in these liquid nutritional compositions often exhibit high aqueous solubility and good sensory characteristics. Due to their high solubility and pleasing

organoleptic properties, dairy proteins {e.g., whey protein) are a common source of proteins in these liquid nutritional compositions.

[0005] To reduce costs, it would be desirable to use vegetable proteins and other low cost, readily accessible proteins as part of the protein component in liquid nutritional compositions. Rice protein is one example of such a vegetable protein. However, introduction of a protein source like rice protein into a nutrition shake presents problems because the proteins typically exhibit low aqueous solubility and fail to provide the consumer the consistency, flavor, or desirable sensory characteristics that they expect (e.g., rice protein is known to exhibit a grainy texture).

[0006] While attempts have been made in the past to introduce vegetable proteins such as rice protein into liquid nutritional compositions and achieve the wide consumer acceptance of conventional (i.e., dairy-based) nutritional compositions, this has yet to be accomplished.

Accordingly, there is an unmet need for protein systems that include rice protein and

demonstrate good aqueous solubility and overall desirable sensory characteristics in a liquid nutritional composition.

SUMMARY

[0007] In accordance with the general inventive concepts, it has been found that protein systems comprising a rice protein ingredient demonstrate enhanced performance in a liquid nutritional composition. In particular, a protein ingredient such as rice protein, which may have previously been considered a poor choice for use in a liquid nutritional composition owing to its poor aqueous solubility, can now be utilized in accordance with the general inventive concepts and make an attractive alternative protein source for liquid nutritional compositions.

[0008] In certain exemplary embodiments, this is achieved through combination of the rice protein with other non-rice proteins in particular percentages or ratios. In certain exemplary embodiments, this is achieved through modification of one or more properties of the rice protein, such as reducing the average particle size of the protein ingredient or subjecting the protein ingredient to hydrolysis (e.g., enzymatic hydrolysis).

[0009] In a first exemplary embodiment, a nutritional composition comprising a protein component, a carbohydrate component, and a fat component is provided. The protein component constitutes 1 % to 20% by weight of the nutritional composition, 5% to 50% by weight of the protein component is rice protein, 50% to 95% by weight of the protein component is non-rice protein, and 30%> to 100% of the protein component is soluble protein. [0010] In a second exemplary embodiment, a nutritional composition comprising a protein component, a carbohydrate component, and a fat component is provided. The protein component constitutes 1 % to 20% by weight of the nutritional composition. The protein component comprises rice protein and at least one non-rice protein. The rice protein has a degree of hydrolysis of 5% to 10%.

[0011] In a third exemplary embodiment, a protein system for use in a nutritional composition (i.e., a nutritional beverage) is provided. The protein system comprises intact rice protein, wherein 70% to 100% of the intact rice protein has a particle size of less than 30 microns.

[0012] In a fourth exemplary embodiment, a method for improving the organoleptic profile of a nutritional composition comprising intact rice protein is provided. The method comprises providing an intact rice protein wherein 70% to 100% of the intact rice protein has a particle size of less than 30 microns and combining the intact rice protein with a carbohydrate component and a fat component to form a nutritional composition.

[0013] In a fifth exemplary embodiment, a nutritional composition comprising a protein component, a carbohydrate component, and a fat component is provided. The protein component constitutes 1% to 20%> by weight of the nutritional composition, 25% to 50%> by weight of the protein component is vegetable protein, and 50%> to 75% by weight of the protein component is non-rice protein. The protein component comprises at least 8 g of L-glutamine per 100 g of protein, at least 4 g of L-arginine per 100 g of protein, and from 0 g to about 1 g of free amino acids per 100 g of protein.

DETAILED DESCRIPTION

[0014] For the purposes of this disclosure, the following terms have the following meanings unless context dictates otherwise:

[0015] "Nutritional composition" refers to nutritional liquids, nutritional solids including nutritional powders which may be reconstituted to form a nutritional liquid, nutritional puddings, nutritional gels, nutritional bars, and other nutritional products all of which comprise one or more of protein, carbohydrate, and fat, and are suitable for oral consumption by a human. In certain exemplary embodiments, the nutritional composition comprises a protein system as disclosed or suggested herein.

[0016] "Total protein" and "total amount of protein" are used interchangeably in connection with the amount of protein in a protein system, a protein component, or a particular nutritional composition to mean all the protein in that system, component, or composition.

[0017] "Vegetable protein" refers to a protein from a source other than animal origin, non- limiting examples of which include: potato protein, soy protein, rice protein, wheat protein, legume protein, hydrolyzed soy protein, hydrolyzed rice protein, hydrolyzed wheat protein, and hydrolyzed legume protein. In certain exemplary embodiments, for example, when rice protein is present in the protein system or component, vegetable protein refers to the vegetable proteins listed above that are not rice protein.

[0018] "Non-rice protein" refers to a protein from a source other than rice, non- limiting examples of which include: soy protein, potato protein, wheat protein, legume protein, hydrolyzed soy protein, hydrolyzed potato protein, hydrolyzed wheat protein, hydrolyzed legume protein, and dairy protein. Non- limiting examples of dairy protein include: milk protein isolate, milk protein concentrate, sodium caseinate, calcium caseinate, micellar casein, whey protein, whey protein isolate, hydrolyzed milk protein isolate, hydrolyzed milk protein concentrate, hydrolyzed sodium caseinate, hydrolyzed calcium caseinate, and hydrolyzed whey protein.

[0019] "Hydrolyzed protein" refers to a source of protein which has been subjected to a specific treatment whose primary purpose is to hydro lyze proteins. In this regard, it is conventional in this industry to refer to a protein source which has been subjected to a treatment whose primary purpose is to hydro lyze unhydrolyzed (or native) proteins as a source of hydrolyzed proteins, e.g., "hydrolyzed whey protein concentrate." In contrast, when a protein source has not been subjected to such a treatment, it is conventional practice to refer to this product as a source of intact protein, or more commonly to say nothing about the hydrolysis of its protein.

[0020] Another way of referring to the extent of hydro lyzation of a hydrolyzed protein is by noting its Degree of Hydrolysis (DH). A protein with a DH value of, for example, 30 refers to protein in which 30% of the total protein is hydrolyzed (or that 30% of the protein's peptide bonds have been cleaved; e.g., if the intact protein contains 100 peptide bonds, and if 30 of these bonds are cleaved by the hydrolysis process, then the DH of the protein after hydrolysis is 30).

[0021] "Fat" and "oil" are used interchangeably to refer to lipid materials derived or processed from vegetables or animals. These terms also include synthetic lipid materials so long as such synthetic materials are suitable for oral administration to humans. As well known, such materials are normally composed of mixtures of fatty acid triglycerides, which mixtures may also contain fatty acid diglycerides and monoglycerides and even some free fatty acids.

[0022] "Shelf stable" refers to a liquid nutritional composition that remains commercially stable after being packaged and then stored at 18-24° C for at least 3 months.

[0023] All percentages, parts and ratios as used herein, are by weight of the total composition, unless otherwise specified. All such weights as they pertain to listed ingredients are based on the active level and, therefore, do not include solvents or by-products that may be included in commercially available materials, unless otherwise specified.

[0024] All references to singular characteristics or limitations of the present disclosure shall include the corresponding plural characteristic or limitation, and vice versa, unless otherwise specified or clearly implied to the contrary by the context in which the reference is made.

[0025] All combinations of method or process steps as used herein can be performed in any order, unless otherwise specified or clearly implied to the contrary by the context in which the referenced combination is made.

[0026] The compositions of this disclosure may also be substantially free of any optional or selected ingredient or feature described herein. In this context, "substantially free" means that the selected nutritional composition contains less than a functional amount of the optional ingredient, typically less than 1%, including less than 0.5%, including less than 0.1%, and also including zero percent, by weight of such optional or selected ingredient.

[0027] In addition, the compositions of this disclosure may comprise, consist of, or consist essentially of the recited elements, as described herein. [0028] It is intended that when discussing the protein systems disclosed herein, that the discussion may apply equally to the liquid nutritional compositions and the protein components included therein, and vice versa.

[0029] Inclusion of rice protein into, for example, liquid nutritional compositions typically presents several problems, such as 1) poor solubility; 2) gritty mouthfeel; and 3) bitter or otherwise undesirable off-notes. However, it has been found that the total amount of vegetable protein (e.g., rice protein) in a nutritional composition intended for oral consumption can be increased to levels higher than previously thought without adversely affecting its nutritional value, flavor, and other desirable hedonic properties, by using particular combinations and/or types of proteins, or by modifying the protein ingredient. That is to say, it has been found that the undesirable flavor off-notes and other undesirable organoleptic properties that typically result from vegetable protein when used to replace a substantial portion of the milk proteins in a commercially viable nutritional composition intended for oral consumption can be largely eliminated, or at least reduced significantly, if a substantial portion of the vegetable protein used for this replacement is based on rice protein, and in particular, rice protein according to the general inventive concepts.

Product Form

[0030] The exemplary nutritional compositions include those suitable for oral administration. Oral administration, as defined herein, includes any form of administration in which the nutritional composition passes through the esophagus of the individual. For example, oral administration includes nasogastric intubation, in which a tube is run through the nose to the stomach of the individual to administer food or drugs.

[0031] The exemplary nutritional compositions include ready-to-feed liquids, concentrated liquids, liquids derived from nutritional powders (reconstituted liquids), powders, and other solids such as nutrition bars. The liquid nutritional compositions may include solutions

(including clear solutions), suspensions, and emulsions. The powders that are reconstituted to produce a liquid may include any flowable or scoopable particulate solid that can be diluted with water or other aqueous liquid to form a nutritional liquid prior to use. [0032] The exemplary nutritional compositions may be formulated with sufficient kinds and amounts of nutrients to provide a sole, primary, or supplemental source of nutrition or to provide a specialized nutritional product for use in individuals afflicted with specific diseases or conditions or with a targeted nutritional benefit.

Nutritional Powders

[0033] In certain exemplary embodiments, the nutritional composition is in the form of a nutritional powder. The nutritional powder may be reconstituted by the intended user with a suitable aqueous liquid, typically water, in an amount or volume sufficient to form a nutritional liquid for immediate oral use. In this context, "immediate" use generally means within about 48 hours, more typically within about 24 hours, and most typically right after or within 20 minutes of reconstitution. Further, when reconstituted, the nutritional powder provides the desired ingredient concentrations as described hereinafter for the nutritional liquid embodiments.

[0034] The nutritional powder may include spray dried powders, dry mixed powders, agglomerated powders, combinations thereof, or powders prepared by other suitable methods.

Nutritional Liquids

[0035] In certain exemplary embodiments, the nutritional composition is in the form of a nutritional liquid. The nutritional liquid may be formulated in a variety of forms, including emulsions such as oil-in-water, water-in-oil, or complex aqueous emulsions. The nutritional liquids are most typically in the form of oil-in-water emulsions having a continuous aqueous phase and a discontinuous oil phase, suspensions, or clear or substantially clear liquids.

[0036] The nutritional liquids may be and typically are shelf stable. The nutritional liquids typically contain up to 95% by weight of water, including from about 50% to about 95%, also including from about 60% to about 90%, and also including from about 70% to about 85% of water by weight of the nutritional liquid.

Macronutrient Balance

[0037] In certain exemplary embodiments, the nutritional composition contains protein, carbohydrate, and fat in proportions which are suitable for satisfying the nutritional needs of the consumer or patient for which they are intended. Such proportions are well known in the art, and any conventional proportion can be used.

[0038] The general inventive concepts are especially useful in connection with formulating liquid nutritional compositions that are intended for oral consumption by the ordinary consumer and hence are formulated to have a pleasing flavor and the consistency of a conventional shake, as well as powders and concentrates which can be combined with water to form such a liquid nutritional composition. Generally speaking, these nutrition shakes, when in a ready to feed condition, contain protein in an amount of from about 0.5% to about 20% by weight,

carbohydrate in an amount of from about 0.5% to about 35% by weight, and fat in an amount of from about 0.1% to about 25% by weight, with the particular balance of these macronutrients depending on the specific purpose for which a particular nutritional composition is formulated.

[0039] Thus, such compositions, when in a ready to use condition, typically contain concentrations of these macronutrients as set forth in the following Tables 1 to 4, with the percentages shown being based on the entire weight of each composition.

[0040] Table 1 : Macronutrient profile for nutritional composition for muscle building formulations.

[0041] Table 2: Macronutrient profile for nutritional composition for adult supplement.

[0042] Table 3: Macronutrient profile for nutritional composition for diabetics.

[0043] Table 4: Macronutrient profile for nutritional composition for children.

Protein

[0044] In certain exemplary embodiments, the protein system comprises protein from one or more sources. Traditionally, milk proteins have been the proteins of choice for making a wide variety of different nutritional compositions. For various reasons, however, including cost, efforts have been undertaken to replace some or all of these milk proteins with vegetable proteins. However, vegetable proteins normally produce a negative effect on the desirable properties that nutritional compositions exhibit including flavor, odor, viscosity (in the case of liquids), texture, short term stability, long term (shelf) stability, and nutritional value.

[0045] In certain exemplary embodiments, the protein system comprises protein in an amount of about 1% to about 20% by weight of the nutritional composition. In certain exemplary embodiments, the protein system comprises protein in an amount of about 2% to about 8% by weight of the nutritional composition. The protein system may comprise both vegetable protein (e.g., rice) and dairy protein. In certain exemplary embodiments, a protein system for use in a nutritional composition comprises vegetable protein or a source of vegetable protein. Both intact and hydrolyzed versions of vegetable protein can be used. The amount of vegetable protein present in the protein system can vary widely and may be based on the particular needs of the intended consumer, or the intended product form of the nutritional composition. In certain exemplary embodiments, vegetable protein (e.g., rice protein) is present in the protein system in an amount of about 5% to about 50% by weight of the total protein.

[0046] As previously mentioned, in certain exemplary embodiments, a protein system according to the general inventive concepts comprises rice protein and at least one non-rice protein. In certain exemplary embodiments, the protein system comprises non-rice protein in an amount of about 50% to about 95% by weight of the total protein. In certain exemplary embodiments, the protein system comprises non-rice protein in an amount of about 50% to about 75% by weight of the total protein. Examples of non-rice protein include dairy protein and non-rice vegetable protein. In certain exemplary embodiments, a protein system for use in a liquid nutritional composition comprises rice protein and at least one additional vegetable protein or a source of an additional vegetable protein. Non- limiting examples of additional vegetable proteins include: soy protein, potato protein, wheat protein, legume protein, hydrolyzed soy protein, hydrolyzed wheat protein, and hydrolyzed legume protein.

Rice Protein

[0047] In certain exemplary embodiments, the protein system comprises rice protein. The rice protein may be selected from one or more sources. Both intact rice protein and hydrolyzed rice protein sources can be used. Rice proteins derived from both Asian rice (Oryza sativa) and African rice (Oryza glabemma) can be used.

[0048] The amount of rice protein present in the protein system can vary widely and may be based on the particular needs of the intended consumer, or the intended product form of the nutritional composition. In certain exemplary embodiments, rice protein is present in the protein system in an amount of about 5% to about 50% by weight of the total protein. In certain exemplary embodiments, rice protein is present in the protein system in an amount of about 5% to about 25% by weight of the total protein. In certain exemplary embodiments, rice protein is present in the protein system in an amount of about 15% by weight of the total protein. Rice protein is commercially available in the form of rice protein concentrates and isolates. These products are available from a wide variety of different commercial sources including Shanghai Freemen Chemicals Company, LLC of Shanghai, China. Soluble Protein

[0049] In certain exemplary embodiments, the protein system comprises a vegetable protein such as rice protein, wherein a majority of the protein is soluble protein. In certain exemplary embodiments, the rice protein may be present in an amount of about 5% to about 50% by weight of the total protein. In certain exemplary embodiments, the rice protein may be present in an amount of about 10% to about 40% by weight of the total protein. In certain exemplary embodiments, the protein component comprises from about 30%> to about 100% soluble protein, including rice protein. In certain exemplary embodiments, the protein component comprises from about 50% to about 100% soluble protein, including rice protein. In certain exemplary embodiments, the protein component comprises from about 80%> to about 100%) soluble protein, including rice protein. In certain exemplary embodiments, the protein component comprises from about 90%> to about 100%) soluble protein.

[0050] The term "soluble protein" as used herein, refers to those proteins having a solubility of at least about 90% as measured in accordance with a Protein Solubility Measurement l est that includes the following steps: ( 1) suspend the protein at 2.00%) (w/ ^' w) in water; (2) stir vigorously for one hour at 20° C to form a suspension; (3) remove an aliquot of the suspension, and determine protein concentration as total protein; (4) centrifuge the suspension at 3 l ,000 ^x g and at 20° C for one hour; (5) determine the protein concentration in the supernatant (the soluble protein); and (6) express the soluble protein as a percentage of the total protein.

[0051] Table 5 shows a series of reconstitutable powder nutritional compositions formulated for consumption by children, each including a rice protein ingredient. The values for expected percentage of soluble protein and measured percentages of soluble protein are shown for each. The measured amounts of soluble protein exceeded the expected amount for each combination.

total protein

Soluble protein < 89% < 89% < 76% < 76%

expected for

Powder

Soluble protein 97% 96% 97% 100%

measured in

Powder

[0052] The increased soluble protein values may be expected to provide at least one of the following benefits when the rice protein is incorporated into a nutritional composition according to the general inventive concepts: a) improved physical stability/shelf life, b) increased protein functionality (e.g., emulsification capacity), and c) increased protein digestibility.

Hydro lyzed Protein

[0053] In certain exemplary embodiments, the protein system includes hydro lyzed rice protein. Rice protein is an attractive option for inclusion in nutritional compositions for a variety of reasons but is also known to present organoleptic issues for consumers as well. For example, rice protein is known to have a gritty mouthfeel and often inclusion of rice protein may cause a liquid nutritional composition to deposit sediment when sitting on the shelf. However, it is demonstrated herein that inclusion of a hydrolyzed rice protein according to the general inventive concepts may alleviate some or all of these drawbacks. Table 6 shows the results of a hedonic panel comparing a hydrolyzed rice protein source to a non-hydrolyzed rice protein source (the scale for the responses is as follows: ½ very slight; 1 slight; 1 ½ slight to moderate; 2 moderate).

[0054] Table 7 shows an exemplary formulation for a liquid nutritional composition for adults. The composition includes hydrolyzed rice protein in an amount of about 15% of the total protein component in the composition.

[0055] In certain exemplary embodiments, the protein system comprises hydrolyzed rice protein. The amount of hydrolyzed rice protein in the protein system can vary widely. In certain exemplary embodiments, the protein system comprises rice protein wherein said rice protein has a degree of hydrolysis of less than about 30%. In certain exemplary embodiments, the protein system comprises rice protein wherein said rice protein has a degree of hydrolysis of about 5% to about 25%. In certain exemplary embodiments, the protein system comprises rice protein wherein said rice protein has a degree of hydrolysis of about 5% to about 20%. In certain exemplary embodiments, the protein system comprises rice protein wherein said rice protein has a degree of hydrolysis of about 5% to about 15%. In certain exemplary embodiments, the protein system comprises rice protein wherein said rice protein has a degree of hydrolysis of about 5% to about 10%. In certain exemplary embodiments, the protein system comprises rice protein wherein said rice protein has a degree of hydrolysis of about 8%. In certain exemplary embodiments, the protein system comprises rice protein wherein at least about 25% of said rice protein has a molecular weight of less than 3000 Daltons.

Particle Size

[0056] It has been found that rice protein having a particular size distribution provides additional benefits beyond those discussed above. In particular, it has been found that, when included in a liquid nutritional composition, rice protein with a reduced particle size shows enhanced sensory attributes including reduced grittiness and reduced powdery mouthfeel. In certain exemplary embodiments, the protein system comprises rice protein that has been modified to reduce its average particle size. In certain exemplary embodiments, the protein system comprises intact rice protein, wherein about 70% to about 100% of the intact rice protein has a particle size of less than 30 microns. In certain exemplary embodiments, the protein system comprises intact rice protein, wherein about 95% to about 100% of the intact rice protein has a particle size of less than 30 microns. In certain exemplary embodiments, the protein system comprises intact rice protein, wherein about 99% of the intact rice protein has a particle size of less than 30 microns. In certain exemplary embodiments, the protein system comprises intact rice protein, wherein the intact rice protein has an average particle size of less than 20 microns. In certain exemplary embodiments, the protein system comprises intact rice protein, wherein the intact rice protein has an average particle size of less than 10 microns.

[0057] Those of skill in the art will recognize that a variety of methods exist for reducing the particle size of, for example, rice protein. In certain exemplary embodiments, the rice protein that is utilized in the exemplary protein systems has been subjected to milling to reduce the particle size thereof. In certain exemplary embodiments, the rice protein that is utilized in the exemplary protein systems has been subjected to jet milling to reduce the particle size thereof (i.e., it has been jet milled).

[0058] Table 8 shows a series of unmodified rice protein ingredients and their respective particle size distributions. Tricalcium phosphate (TCP), micronized TCP, and ultra micronized TCP are included as a controls for particle size distribution (Xn = n percent of particles less than amount listed in microns).

[0059] In accordance with the general inventive concepts, a method for improving the organoleptic profile of a nutritional composition comprising intact rice protein is provided. In certain exemplary embodiments, the method comprises providing an intact rice protein wherein about 90 to about 100% of the intact rice protein has a particle size of less than 30 microns, and combining the intact rice protein with a carbohydrate component and a fat component to form a nutritional composition. In certain exemplary embodiments, the particle size of the intact rice protein is reduced by jet milling of the intact rice protein. In certain exemplary embodiments, the nutritional composition is a liquid. In certain exemplary embodiments, about 99% of the intact rice protein has a particle size of less than 30 microns. In certain exemplary embodiments, the average particle size of the intact rice protein is less than about 12 microns. Dairy Protein

[0060] In certain exemplary embodiments, a protein system comprises a dairy protein. The dairy protein may be selected from one source or more than one source. There are two basic types of dairy proteins, casein and whey. These proteins occur naturally in milk in a weight ratio of about 20% by weight whey and 80% by weight casein. Dairy proteins are commercially available in a variety of different forms. Examples include milk protein isolates, concentrates, casemates, whey isolates or concentrates, milk, non-fat dry milk, skim milk powder, condensed skim milk, and micellar proteins such as micellar caseins and micellar milk protein concentrate all of which may be useful in certain exemplary embodiments.

[0061] The amount of dairy protein present in the protein system can vary widely and may be based on the particular needs of the intended consumer, or the intended product form of the nutritional composition. In certain exemplary embodiments, the protein system comprises dairy protein in an amount of about 50% to about 95% by weight of the total amount of protein. In certain exemplary embodiments, the protein system comprises dairy protein in an amount of about 50% to about 75% by weight of the total amount of protein. The dairy protein may be provided by at least one of milk protein isolate, milk protein concentrate, sodium caseinate, calcium caseinate, micellar casein, whey protein, whey protein isolate, hydrolyzed milk protein isolate, hydrolyzed milk protein concentrate, hydrolyzed sodium caseinate, hydrolyzed calcium caseinate, and hydrolyzed whey protein.

Potato Protein

[0062] In certain exemplary embodiments, the protein system may comprise potato protein or a source of potato protein. The potato protein may be selected from one or more sources. Both intact and hydrolyzed protein can be used. The amount of potato protein present in the protein system can vary widely and may be based on the particular needs of the intended consumer, or the intended product form of the nutritional composition.

Soy Protein

[0063] In certain exemplary embodiments, the protein system may comprise soy protein or a source of soy protein. The soy protein may be selected from one or more sources. Both intact soy protein and hydrolyzed soy protein sources can be used. The amount of soy protein present in the protein system can vary widely and may be based on the particular needs of the intended consumer or the intended product form of the nutritional composition.

Wheat Protein

[0064] In certain exemplary embodiments, the protein system may comprise wheat protein or a source of wheat protein. The wheat protein may be selected from one or more sources. Both intact wheat protein and hydrolyzed wheat protein sources can be used. The amount of wheat protein present in the protein system can vary widely and may be based on the particular needs of the intended consumer, or the intended product form of the nutritional composition.

Legume Protein

[0065] In certain exemplary embodiments, the protein system may comprise legume protein. The legume protein may be selected from one or more sources. While soy protein is a legume, for the purposes of this disclosure, the term "legume protein" will refer to legume proteins other than soy protein, including but not limited to pea protein and lentil protein. Both intact legume protein and hydrolyzed legume protein sources can be used. The amount of legume protein present in the protein system can vary widely and may be based on the particular needs of the intended consumer or the intended product form of the nutritional composition.

Amino Acids

[0066] In certain exemplary embodiments, the protein system comprises an amino acid content which meets or exceeds the World Health Organization (WHO) recommended guidelines (WHO Technical Report 935, 2007) for a "good source of protein." The amount of certain amino acids present in the protein system or the nutritional composition can vary widely and may be based on the particular needs of the intended consumer, or the intended product form. In certain exemplary embodiments, the protein system comprises about 30 mg to about 80 mg of lysine per 1 g of total protein. In certain exemplary embodiments, the protein system comprises at least about 40 mg of lysine per gram of total protein. In certain exemplary embodiments, the protein system comprises at least about 45 mg of lysine per gram of total protein. In certain exemplary embodiments, the protein system comprises at least about 52 mg of lysine per gram of total protein. In certain exemplary embodiments, the protein system comprises at least about 64 mg of lysine per gram of total protein. In certain exemplary embodiments, the source of lysine may be one or more metal lysinates, for example, zinc L-lysinate, calcium L-lysinate, magnesium L- lysinate, etc. In certain exemplary embodiments, the protein system comprises at least about 8 g of L-glutamine per 100 g of protein. In certain exemplary embodiments, the protein system comprises at least about 4 g of L-arginine per 100 g of protein. In certain exemplary

embodiments, the protein system comprises from 0 g to about 1 g of free amino acids per 100 g of protein.

[0067] Individual protein sources have unique amino acid profiles, and thus, while any one source may provide adequate amounts of particular amino acids, it may, in turn, be deficient in others. Therefore, in certain instances, a combination of one or more protein additional ingredients may serve to complement the amino acid content above that which was achievable with only a single source.

[0068] In addition to the advantages noted above, other advantages may be realized via the following embodiments. In particular, it has advantageously been found that the combination of rice protein and whey protein provide certain benefits.

[0069] Whey protein has relatively lower levels of, for example histidine, glutamine, and arginine. Whereas vegetable proteins (e.g., rice protein) have relatively lower levels of, for example lysine, sulfur amino acids, and threonine. Rice protein is a preferable choice for the vegetable protein, as rice protein amino acid deficiencies are nicely compensated by the whey protein, and vice versa. An additional benefit of combining proteins is shown by the elimination (or reduction) of fortification of nutritional compositions with free amino acids. Previously, when faced with a protein ingredient that is deficient in one or more amino acids, producers would fortify the composition with a source of the free amino acid to make up for the deficiency. However, free amino acids suffer from stability issues and inadequate consumer acceptance due to taste. In contrast, protein bound amino acids provide the amino acids in a shelf stable form, especially for conditionally essential amino acids such as L-glutamine and L-arginine.

[0070] Table 9 shows the concentrations of selected amino acids (mg/g of total protein) in casein, rice, and whey protein. Table 9

Amino Acid Casein Rice Whey

His 28 28 19

He 50 50 66

Leu 97 80 113

Lys 80 32 93

Met + Cys 32 23 46

Phe + Tyr 109 96 64

Thr 44 24 77

Trp 14 12 17

Val 64 101 60

Arg 38 72 26

Gin 104 130 63

[0071] Table 10 shows the amino acid content of an exemplary liquid nutritional composition for children formulated with total protein at 30.0 g/L, whey protein at 21.0 g/L (70%) and casein protein at 9.0 g/L (30%>). The distributions of selected amino acids (mg/g of total protein) in the control formulation (whey/casein, 70/30) and in an exemplary protein system (whey/rice, 70/30), along with the FAO protein quality requirements for children 6M to 36M are shown in Table 10.

Lys 57 89 75

Met + Cys 27 42 39

Phe + Tyr 52 78 74

Thr 31 67 61

Trp 8.5 16 15

Val 43 61 72

Arg N/A 30 40

Gin N/A 75 83

[0072] Table 11 shows the amino acid content of an exemplary liquid nutritional composition for adults formulated with total protein at 67.5 g/L, whey protein at 47.25 g/L (70%) and casein protein at 20.25 g/L (30%). The distributions of selected amino acids in the control formulation (whey/casein, 70/30) and in an exemplary protein system (whey/rice, 60/40) along with the FAO protein quality requirements for adults are shown in Table 11.

Val 40 62 76

Arg N/A 31 44

Gin N/A 79 90

[0073] As can be seen from Tables 10 and 11, the combination of rice protein and whey protein creates a protein system that provides a nutritionally complete protein source and meets or exceeds the recommendations for the amino acids.

[0074] Table 12 shows a side -by-side comparison of a series of reconstitutable powder nutritional compositions with similar protein composition profiles. Formulas 2-4 include amounts of metal lysinates as a portion of the total lysine in the compositions.

[0075] In addition to the above proteins and amino acids, the protein systems and nutritional compositions can also contain free amino acids, if desired, so long as the amounts are in accordance with the discussion above. Examples include L-arginine, L-cysteine, L-glutamine, L-leucine, L-proline, L-valine, L-isoleucine, and L-tryptophan. Particularly suitable free amino acids include L-arginine and L-glutamine. Desirable branched chain amino acids include L- leucine, L-isoleucine, and L-valine.

Carbohydrate

[0076] In certain exemplary embodiments, the protein system is used in a nutritional composition that also includes carbohydrate or a carbohydrate component. The amount of carbohydrate present in the nutritional composition can vary widely and may be based on the particular needs of the intended consumer or the intended product form. In certain exemplary embodiments, the carbohydrate or carbohydrate component, is present in an amount of about 5% to about 65% by weight of the nutritional composition. Any carbohydrate or source thereof that is suitable for use in oral nutritional products and is compatible with the other ingredients of the inventive compositions can be used as the carbohydrate in the nutritional compositions. Non- limiting examples of a source of carbohydrate suitable for use in the nutritional compositions described herein include maltodextrin, hydrolyzed or modified starch or cornstarch, glucose polymers, corn syrup, corn syrup solids, rice-derived carbohydrates, sucrose, glucose, fructose, lactose, high fructose corn syrup, honey, sugar alcohols (e.g., maltitol, erythritol, sorbitol), isomaltulose, sucromalt, pullulan, potato starch, slowly-digested carbohydrates, dietary fibers (e.g., oat fiber, soy fiber, gum arabic, sodium carboxymethylcellulose, methylcellulose, guar gum, gellan gum, locust bean gum, konjac flour, hydroxypropyl methylcellulose, tragacanth gum, karaya gum, gum acacia, chitosan, arabinogalactans, glucomannan, xanthan gum, alginate, pectin, low and high methoxy pectin, cereal beta-glucans (e.g., oat beta-glucan, barley beta- glucan), carrageenan and psyllium), Fibersol™, other resistant starches, and combinations thereof. Fat

[0077] In certain exemplary embodiments, the protein system is used in a nutritional

composition that also includes fat or a fat component. The amount of fat present in the nutritional composition can vary widely and may be based on the particular needs of the intended consumer or the intended product form. In certain exemplary embodiments, fat or a fat component is present in an amount of about 1% to about 20% by weight of the nutritional composition. Any fat or source thereof that is suitable for use in oral nutritional products and is compatible with the other ingredients of the inventive compositions can be used. Non-limiting examples of suitable fats or sources thereof for use in the nutritional compositions described herein include coconut oil, fractionated coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT (medium chain triglycerides) oil, sunflower oil, high oleic sunflower oil, palm and palm kernel oils, palm olein, canola oil, high oleic canola oil, marine oils, cottonseed oils, and combinations thereof. Desirably, a fat source will provide at least one long chain polyunsaturated acid (LC-PUFA) such as DHA, ARA, and/or EPA, although these LC-PUFAs may be optionally added to the nutritional compositions outside of, or in addition to, the other sources of fat.

[0078] In certain exemplary embodiments, the nutritional composition is desired to be clear, or at least substantially translucent, and is substantially free of fat. As used herein "substantially free of fat" refers to a nutritional composition containing less than 0.5%, including less than 0.1%, fat by weight of the total composition. "Substantially free of fat" also may refer to a nutritional composition disclosed herein that contains no fat, i.e., zero fat. In those embodiments of the nutritional composition that are substantially free of fat but have some amount of fat present, the fat may be present as a result of being inherently present in another ingredient or the fat may be present as a result of being added as one or more separate sources of fat.

Optional Ingredients

[0079] In certain exemplary embodiments, the nutritional composition including the protein system may further comprise other optional ingredients that may modify its physical, chemical, hedonic, or processing characteristics or serve as pharmaceutical or additional nutritional components when used in the targeted population. Many such optional ingredients are known or otherwise suitable for use in other nutritional compositions and may also be used in the nutritional compositions described herein, provided that such optional ingredients are safe and effective for oral administration and are compatible with the essential and other ingredients in the selected product form.

[0080] Different sources and types of proteins, carbohydrates, fats, vitamins, and minerals, are known and may be used in the exemplary embodiments disclosed or suggested herein, provided that such nutrients are compatible with the other ingredients in the selected formula, are safe for their intended use, and do not otherwise unduly impair product performance.

[0081] In certain exemplary embodiments, the nutritional composition further comprises any of a variety of vitamins or related nutrients, non-limiting examples of which include vitamin A, vitamin D, vitamin E, vitamin K, thiamine, riboflavin, vitamin B6, vitamin B12, carotenoids, niacin, folic acid, pantothenic acid, biotin, vitamin C, choline, inositol, salts, and derivatives thereof, and combinations thereof.

[0082] In certain exemplary embodiments, the nutritional composition further comprises any of a variety of minerals, non-limiting examples of which include phosphorus, magnesium, calcium, iron, zinc, manganese, copper, sodium, potassium, molybdenum, chromium, selenium, chloride, iodide, and combinations thereof.

[0083] In certain exemplary embodiments, the nutritional composition may be an "excellent source of (as defined by the Food and Drug Administration) at least one of the following:

calcium, iron, riboflavin, vitamin B6, folate, pantothenic acid, phosphorous, iodine, zinc, selenium, manganese, copper, chromium, molybdenum, and combinations thereof.

[0084] In certain exemplary embodiments, the nutritional composition may be a "good source of (as defined by the Food and Drug Administration) at least one of the following: vitamin A, vitamin C, vitamin E, thiamin, niacin, biotin, and combinations thereof.

[0085] Non-limiting examples of other optional ingredients include fiber, preservatives, additional antioxidants, emulsifying agents, buffers, colorants, flavors, probiotics, prebiotics, thickening agents and stabilizers, and so forth. [0086] In certain exemplary embodiments, the nutritional composition comprises fiber or a source of fiber. The fiber may be provided by one source or multiple sources of fiber. The particular amount of fiber present in the nutritional composition may vary depending upon the nutritional needs of the intended consumer. Fiber is defined as the indigestible portion of food consumed by animals. Dietary fiber is often categorized into soluble and insoluble fiber sources. Non-limiting examples of fibers and sources thereof which may be suitable for use in the exemplary embodiments include: insoluble fibers such as raffinose and lignin; and soluble fibers such as inulin, fructooligosaccharides (FOS), galactooligosaccharides (GOS), beta-glucans, xylose, and polydextrose.

[0087] In certain exemplary embodiments, the nutritional composition comprises at least one sweetening agent. In certain exemplary embodiments, the at least one sweetening agent is a sugar alcohol such as maltitol, erythritol, sorbitol, xylitol, mannitol, isolmalt, lactitol, and combinations thereof, or at least one artificial or high potency sweetener such as acesulfame K, aspartame, sucralose, saccharin, stevia, tagatose, monk fruit and combinations thereof. The sweetening agents, especially as a combination of a sugar alcohol and an artificial sweetener, may be especially useful in formulating nutritional compositions having a desirable flavor profile. These sweetener combinations can effectively mask undesirable flavors, for example, as sometimes associated with the addition of vegetable proteins to a nutritional composition. In certain exemplary embodiments, the nutritional composition may comprise at least one sugar alcohol with a concentration of from at least 0.01%, including from about 0.1% to about 10%, and also including from about 1% to about 6% by weight of the nutritional composition. In certain exemplary embodiments, the nutritional composition may comprise at least one artificial sweetener with a concentration of from 0.01% to 5%, including from 0.05%> to 3%, and also including from 0.1% to 1% by weight of the nutritional composition.

[0088] In certain exemplary embodiments, the nutritional composition comprises a stabilizer. Any stabilizer that is known or otherwise suitable for use in a nutritional composition may be suitable for use herein, some non-limiting examples of which include gums such as carrageenan and xanthan gum. In certain exemplary embodiments, the stabilizer may represent from about 0.1%) to about 5%), including from about 0.5%> to about 3%, and including from about 0.7%> to about 1.5% by weight of the nutritional composition. [0089] In certain exemplary embodiments, the nutritional composition comprises one or more masking agents to reduce or otherwise obscure the effects of any bitter flavors and after taste that may develop in the nutritional composition over time. Suitable masking agents include natural and artificial sweeteners; sodium sources such as sodium chloride; and combinations thereof. The amount of masking agent added to the nutritional composition may vary depending upon the particular masking agent selected, other ingredients in the formulation, and other formulation or product target variables. Such amounts, however, can range from about 0.1% to about 3%, including from about 0.15% to about 3%, and also including from about 0.2% to about 2.5%, by weight of the nutritional composition.

[0090] The various nutritional compositions disclosed herein, as well as other embodiments contemplated by the general inventive concepts, may be prepared by any process or suitable method (now known or known in the future) for making a selected product form, such as a nutritional liquid, a nutritional solid, or a nutritional powder. Many such techniques are known for any given product form and can easily be applied by one of ordinary skill in the art to the various embodiments presented herein.

Methods of Manufacture

[0091] In certain exemplary embodiments, the protein system and the nutritional compositions including same may be manufactured by any known or otherwise suitable method. Inventive nutritional compositions in liquid form may be suitably sterilized, for example, by aseptic sterilization or retort sterilization.

[0092] In those embodiments in which the nutritional compositions are in the form of a nutrition shake, they may be prepared by any of the well known methods of formulating such compositions by way of retort, aseptic packaging, or hot fill processing methods.

[0093] For example, in one suitable manufacturing process for formulating a nutrition shake, at least three separate slurries are prepared, including a protein-in-fat (PIF) slurry, a carbohydrate- mineral (CHO-MIN) slurry, and a protein-in-water (PIW) slurry. The PIF slurry is formed by heating and mixing the oil (e.g., canola oil, corn oil) and then adding an emulsifier (e.g., lecithin), fat soluble vitamins, and a portion of the total protein with continued heat and agitation. The CHO-MIN slurry is formed by adding with heated agitation to water: minerals (e.g., potassium citrate, dipotassium phosphate, sodium citrate), trace and ultra trace minerals

(TM/UTM premix), thickening or suspending agent. The resulting CHO-MIN slurry is held for 10 minutes with continued heat and agitation before adding additional minerals (e.g., potassium chloride, magnesium carbonate, potassium iodide), and/or carbohydrates (e.g., HMOs, fructooligosaccharide, sucrose, corn syrup). The PIW slurry is then formed by mixing with heat and agitation the remaining protein, if any. Those of skill in the art will recognize that other exemplary methods exist for combining the necessary ingredients, for example, in one exemplary embodiment, the protein is mixed into the PIW slurry, and thus only two slurries are used in the process.

[0094] The resulting slurries are then blended together with heated agitation and the pH adjusted to 6.6-7.0, after which the composition is subjected to ultra high temperature (UHT) processing during which the composition is heat treated, emulsified, and homogenized and then allowed to cool. Water soluble vitamins and ascorbic acid are added, the pH is adjusted to the desired range if necessary, flavors are added, and water is added to achieve the desired total solid level. The composition is then aseptically packaged to form an aseptically packaged nutritional emulsion.

[0095] The following examples further describe and demonstrate specific embodiments within the scope of the general inventive concepts. The examples are given solely for the purpose of illustration and are not to be construed as limitations of the present invention, as many variations thereof are possible without departing from the spirit and scope of the invention. All exemplified amounts are weight percentages based upon the total weight of the composition, unless otherwise specified.

[0096] Table 13 shows two exemplary embodiments of a nutritional composition in the form of a reconstitutable powdered nutritional shake intended for children comprising an exemplary protein system. All ingredient amounts are listed as the total amount included in a 1000 kg batch. [0097] Although only a few exemplary embodiments have been described above, it should be appreciated that many other embodiments exist including those derived from modifications made to the disclosed embodiments, and all such embodiments fall within the spirit and scope of the general inventive concepts.