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Title:
NUTRITIONAL COMPOSITIONS WITH PROTEIN, BETA-HYDROXY-BETA-METHYLBUTYRATE (HMB), AND FIBER
Document Type and Number:
WIPO Patent Application WO/2018/125931
Kind Code:
A1
Abstract:
Nutritional compositions have at least 60 g/L of protein, beta-hydroxy-beta-methylbutyrate (HMB), and a source of soluble fiber and a source of insoluble fiber. Methods involve preparing a nutritional composition having reduced Maillard browning in a heat sterilized nutritional composition involving providing a nutritional composition comprising at least 60 g/L of protein, beta-hydroxy-beta-methylbutyrate (HMB), and a source of soluble fiber and a source of insoluble fiber, and heat sterilizing the nutritional composition.

Inventors:
JOHNS PAUL (US)
MCKENNA RONALD (US)
Application Number:
PCT/US2017/068572
Publication Date:
July 05, 2018
Filing Date:
December 27, 2017
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
ABBOTT LAB (US)
International Classes:
A23L33/10; A23L33/17; A23L33/21
Foreign References:
US20160037815A12016-02-11
US20150237903A12015-08-27
US20130337144A12013-12-19
KR20150119991A2015-10-27
US20140349953A12014-11-27
US20140349953A12014-11-27
US20050220845A12005-10-06
Other References:
ANONYMOUS: "HMB (beta-hydroxy-beta-methylbutyrate): A scienticif review", INTERNET CITATION, 1 April 2010 (2010-04-01), pages 1 - 34, XP002670332, Retrieved from the Internet [retrieved on 20120224]
BHAVBHUTI M. ET AL., COMPREHENSIVE REVIEWS IN FOOD SCIENCE AND FOOD SAFETY, vol. 15, 2016, pages 206 - 216
MCEWEN J.W.: "Effect of Carbohydrate DE on Blocked Lysine and Furosine in a Liquid Nutritional Product", FOOD CHEMISTRY, vol. 119, 2010, pages 323 - 327, XP026692055, DOI: doi:10.1016/j.foodchem.2009.06.038
Attorney, Agent or Firm:
STOREY, Bill (US)
Download PDF:
Claims:
CLAIMS

1. A nutritional composition comprising:

at least 60 g/L of protein;

beta-hydroxy-beta-methylbutyrate (HMB);

a source of soluble fiber; and

a source of insoluble fiber comprising at least 1% of a total carbohydrate content of the nutritional composition.

2. The nutritional composition of claim 1, comprising from about 60 g L to about 90 g/L of the protein.

3. The nutritional composition of claim 1 or 2, wherein the protein source comprises sodium caseinate, calcium caseinate, milk protein concentrate, soy protein isolate, whey protein concentrate, or a combination of two or more thereof.

4. The nutritional composition of claim 1 or 2, wherein the protein source comprises from about 40% to about 75% sodium caseinate, from about 25% to about 35% milk protein concentrate, from about 15% to about 25% soy protein isolate, and from about 1% to about 5% whey protein.

5. The nutritional composition of claim 1 or 2, wherein the protein source comprises sodium caseinate, soy protein isolate, and calcium caseinate. 6. The nutritional composition of any one of claims 1-5, wherein the soluble fiber source and the insoluble fiber source together comprise from about 1% to about 10% of a total carbohydrate content of the nutritional composition.

7. The nutritional composition of any one of claims 1-5 wherein the insoluble fiber sources and the soluble fiber sources together comprise from about 3% to about 8% of a total carbohydrate content of the nutritional composition.

8. The nutritional composition of any one of claims 1-7, comprising from about 0.1 g/L to about lO g/L HMB.

9. The nutritional composition of any one of claims 1-8 further comprising from about 1% to about 10% fat.

10. The nutritional composition of any one of claims 1-9 further comprising from about 3% to about 8% fat.

11. The nutritional composition of any one of claims 1-10, having a total solids level from about 20% to about 45%.

12. The nutritional composition of any one of claims 1-11, wherein the soluble fiber source comprises gum arabic and/or carboxymethylcellulose and the insoluble fiber source comprises oat fiber and/or soy fiber.

13. The nutritional composition of any one of claims 1-1 1, wherein the soluble fiber source comprises gum arable and carboxymethyl cellulose and the insoluble fiber source comprises oat fiber and soy fiber.

14. A method for preparing a heat sterilized nutritional composition having reduced Maillard browning, the method comprising:

providing a nutritional composition comprising:

at least 60 g/L of protein;

beta-hydroxy-beta-methylbutyrate (HMB);

a source of soluble fiber; and

a source of insoluble fiber comprising at least 1% of a total carbohydrate content of the nutritional composition; and

heat sterilizing the nutritional composition.

15. The method of claim 14, wherein the nutritional composition comprises from about 60 g/L to about 90 g/L of the protein.

Description:
NUTRITIONAL COMPOSITIONS WITH PROTEIN, BETA-HYDROXY-BETA- METHYLBUTYRATE (HMB), AND FIBER

TECHNICAL FIELD

[0001] High protein nutritional compositions and methods for producing and using these compositions are disclosed. More specifically, high protein nutritional compositions containing beta-hydroxy-beta-methylbutyrate (HMB), and soluble and insoluble fiber sources, and methods for producing and using the compositions, are described.

BACKGROUND

[0002] Stability and quality are necessities for production of nutritional compositions. Heating processes during production can affect nutritional composition quality and stability by degrading or inactivating heat-labile compounds. Application of heat during nutritional composition production can also accelerate a nonenzymatic chemical reaction known as Maillard browning, particularly in compositions containing proteins and amino acids.

[0003] Despite the fact that the Maillard reaction is well-defined, controlling and eliminating undesirable reaction products remains a significant industry problem. Current approaches to inhibiting the reaction involve very specific composition additions such as polyphenol containing plant extracts (US 2014/0349953 Al) or hydrogenated dextrin (US 2005/0220845 Al).

However the effectiveness of these approaches is limited, and current approaches are sometimes inappropriate for specific nutritional compositions. Additionally, current approaches sometimes involve components counter-indicated for individuals taking specific medicines. Applicant has discovered compositions containing HMB and specific soluble and insoluble fiber sources reduce browning from the Maillard reaction.

SUMMARY

[0004] The invention is generally directed to nutritional compositions comprising: at least 60 g L of protein; beta-hydroxy-beta-methylbutyrate (HMB); a source of soluble fiber; and a source of insoluble fiber compri sing at least 1% of a total carbohydrate content of the nutritional composition.

[0005] Additional embodiments are directed to methods for preparing heat sterilized nutritional compositions having reduced Maillard browning, the method comprising: providing a nutritional composition comprising: at least 60 g L of protein; beta-hydroxy-beta methylbutyrate (HMB); a source of soluble fiber; and a source of insoluble fiber comprising at least 1% of a total carbohydrate content of the nutritional composition; and heat sterilizing the nutritional composition.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The embodiments set forth in the drawings are illustrative and exemplary in nature and not intended to limit the invention defined by the claims. The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, in which:

[0007] FIG. 1 illustrates furosine levels following aseptic or retort heat treatment for a base composition and a composition with fiber components; [0008] FIG. 2 illustrates blocked lysine levels following aseptic or retort heat treatment for a base composition and a composition with fiber components;

[0009] FIG. 3 illustrates ionic calcium levels following aseptic or retort heat treatment for a base composition and a composition with fiber components;

[0010] FIG. 4 illustrates soluble calcium levels following aseptic or retort heat treatment for a base composition and a composition with fiber components; and

[0011] FIG. 5 illustrates via a bar graph the substantial and surprising beneficial effect of fiber components on Maillard browning inhibition, with the fiber component percentage depicted as a percentage of the total carbohydrate content of the composition.

DETAILED DESCRIPTION

[0012] Specific embodiments of the present disclosure will now be described. The invention may, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided to illustrate more specific features of certain aspects of the invention to those skilled in the art.

[0013] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which embodiments of this invention belong. The terminology used herein is for describing particular embodiments only and is not intended to be limiting of the invention. As used in the specification and appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0014] Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weight, reaction conditions, and so forth as used in the specification and claims are to be understood as being modified in all instances by the term "about," which is intended to mean up to ±10% of an indicated value. Additionally, the disclosure of any ranges in the specification and claims are to be understood as including the range itself and also anything subsumed therein, as well as endpoints. Unless otherwise indicated, the numerical properties set forth in the specification and claims are approximations that may vary depending on the desired properties sought to be obtained in embodiments of the present invention. Notwithstanding that numerical ranges and parameters setting forth the broad scope of embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical values, however, inherently contain certain errors necessarily resulting from error found in their respective measurements.

[0015] Unless otherwise indicated, percentages are provided as weight percentage of the solution.

[0016] The terms "nutritional composition" or "nutritional product" as used herein, unless otherwise specified, refer to nutritional liquids and may comprise ready-to-drink liquid forms, concentrated forms, or reconstituted forms of compositions including powders prepared at standard dilution.

[0017] The nutritional compositions can be aqueous emulsions comprising fat, protein, and carbohydrate. These emulsions can be flowable or drinkable liquids at from about 1°C to about 25°C and are typically in the form of oil-in-water, water-in-oil, or complex aqueous emulsions, although such emulsions are most typically in the form of oil-in-water emulsions having a continuous aqueous phase and a discontinuous oil phase.

[0018] In a first embodiment, the nutritional compositions comprise protein, HMB, a source of soluble fiber, and a source of insoluble fiber. Protein

[0019] The nutritional compositions may be considered high protein compositions. As used herein, the term "high protein" comprises a protein component concentration of at least 60 g/L. Specific non-limiting embodiments of nutritional composition protein concentrations include: from about 60 g/L to about 180 g/L, or from about 90g/L to about 150g/L, or from about 110 g/L to about 125 g/L. Additional embodiments include ranges, for example, such as: from about 60 g/L to about 120 g/L, or from about 60 g L to about 90 g/L, or from about 70 g/L to about 110 g/L, or from about 80 g/L to about 100 g/L, or from about 90 g/L to about 95 g/L, or from about 80 g/L to about 90 g/L.

[0020] Non-limiting examples of suitable protein or sources thereof for use in the nutritional products include hydrolyzed, partially hydrolyzed or non-hydrolyzed proteins or protein sources, which may be derived from any known or otherwise suitable source such as milk (e.g., casein, whey), animal (e.g., meat, fish), cereal (e.g., rice, corn), vegetable (e.g., soy, pea, canola) or combinations thereof. Non-limiting examples of such proteins include whole egg powder, egg yolk powder, egg white powder, whey protein, whey protein concentrate, whey protein isolate, whey protein hydrolysate, acid casein, casein protein isolates, sodium caseinate, calcium caseinate, potassium caseinate, casein hydrolysate, milk protein concentrate, milk protein isolate, milk protein hydrolysate, nonfat dry milk, whole cow's milk, partially or completely defatted milk, coconut milk, soy protein concentrate, soy protein isolate, soy protein hydrolysate, pea protein concentrate, pea protein isolate, pea protein hydrolysate, rice protein concentrate, rice protein isolate, rice protein hydrolysate, collagen protein, or a combination of two or more thereof. [0021] In specific embodiments, as a percentage of the total protein in the nutritional composition, the high protein nutritional composition comprises sodium caseinate in a range from about 40% to about 75%, milk protein concentrate in a range from about 25% to about 35%, soy protein isolate in a range from about 15% to about 25%, and whey protein in a range of about 0% to about 5%. In additional specific embodiments, other non-limiting ranges include: from about 50% to about 70% sodium caseinate, or from about 60% to about 65% sodium caseinate; or from about 20% to about 40% milk protein concentrate, or from about 25 to about 30% milk protein concentrate, or from about 30% to about 35% milk protein concentrate; and/or from about 10% to about 30% soy protein isolate, or from about 10% to about 20% soy protein isolate, or from about 20% to about 30% soy protein isolate; and/or from about 0% to about 10%, or from about 0% to about 7.5%, whey protein, or from about 0 to about 5% whey protein, or from about 1% to about 5% whey protein.

HMB

[0022] The high protein nutritional composition includes HMB. The HMB may be provided in any desired form, and in one embodiment is included as calcium HMB, that has been shown to modulate protein turnover and inhibit proteolysis. The calcium HMB can be a monohydrate. The calcium HMB can be prepared so the nutritional composition contains calcium and HMB in the finished product. Calcium HMB can be added to the composition during or after

formulation.

[0023] Other suitable sources of HMB may include HMB as the free acid, a salt, an anhydrous salt, an ester, a lactone, or other product forms that otherwise provide a bioavailable form of HMB from the nutritional composition. Non-limiting examples of suitable salts of HMB for use herein include HMB salts, hydrated or anhydrous, of sodium, potassium, magnesium, chromium, calcium, or other non-toxic salt form.

[0024] The concentration of calcium HMB in the nutritional emulsions may range up to about 10%, including from about 0.1% to about 8%, and also including from about 0.2% to about 5.0%, and also including from about 0.3% to about 3%, and also including from about 0.4% to about 1.5%, by weight of the nutritional composition.

[0025J In specific embodiments, the high protein nutritional composition comprises from about 0.1 g/L to about 10 g/L HMB. In more specific embodiments, the high protein nutritional composition comprises: from about 2 g/L to about 8 g/L HMB, or from about 3 g/L to about 6 g/L HMB, or from about 4 g/L to about 5 g/L HMB.

Soluble Fiber Source

[0026] The high protein nutritional composition includes one or more soluble fiber sources. The term "soluble fiber" as used herein, refers to a dietary fiber in which at least 60% of the dietary fiber is soluble in water.

[0027] Non-limiting examples of soluble dietary fiber sources that can be included alone or in combination in the high protein nutritional composition include gum arabic, sodium

carboxymethylcellulose (CMC), fructooligosaccharides, gellan gum, guar gum, citrus pectin, low and high methoxy pectin, barley glucans and psyllium.

[0028] Gum arabic is a heterogeneous polysaccharide with slightly acidic characteristics, that can act as an emulsifier, stabilizer, and thickener, and can be obtained from dried exudates of acacia trees. In specific embodiments the high protein nutritional composition contains gum arabic in the form of a potassium salt. In specific embodiments, the high protein nutritional composition includes from about lg/kg to about 3 g/kg gum arabic, or from about 2 g/kg to about 3 g/kg gum arabic, or from about 1.5 g/kg to about 2.5 g/kg gum arabic, based on the weight of the nutritional composition.

[0029] CMC can be in the form of sodium CMC, which is white, odorless, and tasteless. The high protein nutritional composition can contain from about from about 0.5 g/kg to about 1.5 g/kg of CMC, or from about 0.8 g/kg to about 1.2 g kg CMC, or from about 0.9 to about 1.0 g/kg CMC, based on the weight of the nutritional composition.

[0030J In specific embodiments, the CMC form is soluble in both cold or hot water, stable over a pH range of 4.0-10.0, and is compatible with a wide range of other food ingredients, such as proteins, sugars, and other hydrocolloids. In specific embodiments the pH range of the nutritional composition is from about 4.0 to about 10, while other specific embodiments the pH range is from about 6.0 to about 8.0, or about 6.5 to about 7.5, or about 6.8 to about 7.2.

[0031] Gellan gum is a viscous soluble fiber that can be produced by non-pathogenic

bacteria Sphingomonas elodea from lactose (cheese whey) or glucose. It is an indigestible carbohydrate and comprises a mixture of polysaccharides composed of glucose, rhamnose and glucuronic acid. In specific embodiments gellan gum comprises from about 25 to about 200 parts per million (ppm) of the total nutritional composition. In specific embodiments gellan gum comprises from about 50 to about 150 ppm of the total nutritional composition, or from about 75 to about 125 ppm.

Insoluble Fiber Source

[0032] The high protein nutritional compositions also includes one or more insoluble fiber sources. Non-limiting examples of insoluble dietary fiber sources that can be included alone or in combination in the high protein nutritional composition include cellulose, oat fiber, soy fiber, pea hull fiber, beet fiber, and corn bran. One example of insoluble soy fiber is pulp or dreg which remains after pureed soybeans are filtered in the production of soy milk or tofu.

[0033] The high protein nutritional composition can include, for example, from about 1 to about 25 g/kg oat fiber, or from about 5 to about 20 g/kg oat fiber, or from about 7 to about 15 g kg oat fiber. In additional specific embodiments, the high protein nutritional composition includes, for example, 3 g/kg to about 7 g/kg oat fiber, or from about 4 g/kg to about 6 g/kg oat fiber, or from about 5 g/kg to about 6 g/kg oat fiber, based on the weight of the nutritional composition. The high protein nutritional composition can include, for example, from about 1 to about 25 g/kg soy fiber, or from about 5 to about 20 g/kg soy fiber, or from about 7 to about 15 g/kg soy fiber. In specific additional embodiments, the high protein nutritional composition can include, for example, from about 3 g/kg to about 7 g/kg soy fiber, or from about 4 g/kg to about 6 g kg soy fiber or from about 4 g/kg to about 5 g/kg soy fiber, based on the weight of the nutritional composition.

Soluble and Insoluble Fiber Source Combinations

[0034] The high protein nutritional composition includes at least one soluble fiber source and at least one insoluble fiber source that together comprise less than about 10% of the total carbohydrate content of the high protein nutritional composition. In specific embodiments the percentage is less than about 8%, or less than about 5%, less than about 2%, or less than about 1%. In specific embodiments, the soluble fiber source and insoluble fiber source comprise about 1% to about 10%, or from about 2% to about 9%, or from about 3% to about 8%, or from about 4% to about 7%, or from about 5% to about 6% of the total carbohydrate content of the high protein nutritional composition. [0035] In specific embodiments, the high protein nutritional composition comprises at least two, at least three, or at least four sources of insoluble fiber and at least two, at least three, or at least four sources of insoluble fiber, and the soluble fiber sources and the insoluble fiber sources together comprise about 1% to about 10%, or from about 2% to about 9%, or from about 3% to about 8%, or from about 4% to about 7%, or from about 5% to about 6% of the total

carbohydrate content of the high protein nutritional composition.

[0036] Soluble fiber sources and insoluble fiber sources can be formed as a slurry or can be formed as separate slurries that are then combined together. The separate or combined fiber slurries can be added to a protein-fat slurry and a carbohydrate-mineral slurry to form the high protein nutritional composition

Carbohydrate

[0037] Non-limiting examples of suitable carbohydrates or sources thereof for use in the high protein nutritional compositions described herein may include maltodextrin, hydrolyzed or modified starch or cornstarch, glucose polymers, corn syrup, corn syrup solids, rice-derived carbohydrates, glucose, fructose, lactose, high fructose corn syrup, honey, sugar alcohols (e.g., maltitol, erythritol, sorbitol), and combinations thereof.

Fat

[0038] The nutritional compositions of the invention may, optionally, include one or more fat components. The term "fat" as used herein, unless otherwise specified, refers to lipid materials derived or processed from plants or animals. These terms also include synthetic lipid materials so long as such synthetic materials are suitable for oral administration to humans.

[0039] In specific embodiments the high protein nutritional composition comprises from about 1% to about 10% fat. Other non-limiting ranges for the fat components include: from about 2% to about 9% fat, or from about 3% to about 8% fat, or from about 4% to about 7% fat, or from about 5% to about 6% fat. In specific embodiments the high protein nutritional composition comprises from about 0% to about 5% fat, or from about 0% to about 2.5% fat, or from about 0% to about 1% fat, or from about 0% to about 0.5% fat. In specific embodiments the high protein nutritional composition comprises at least two fats. In specific embodiments the high protein nutritional composition comprises canola oil and corn oil. In specific embodiments the ratio of canola oil to corn oil is about 60 to about 40, or from about 55 to about 45, or from about 52 to about 48. In specific embodiments the high protein nutritional composition comprises at least two of canola oil, corn oil, and soy oil. In specific embodiments the high protein nutritional composition comprises canola oil, corn oil, and soy oil.

[0040] Non-limiting examples of suitable fats or sources thereof for use in the nutritional compositions described herein include whole egg powder, egg yolk powder, egg white powder, coconut milk, coconut oil, fractionated coconut oil, soy oil, corn oil, butter oil, olive oil, safflower oil, high oleic safflower oil, medium chain triglycerides (MCT oil), sunflower oil, high oleic sunflower oil, palm oil, palm kernel oil, palm olein, canola oil, algae oil, borage oil, marine oil, fish oil, cottonseed oil, any of said oils in powder form, or a combination of two or more thereof.

Total Solids

[0041] As used herein, "total solids" refers to a total of protein, fat, carbohydrate, and ash in the high protein nutritional composition, referring to the total grams of solid per 100 grams of high protein liquid nutritional composition. In specific embodiments the high protein liquid nutritional composition comprises from about 10 to about 45 grams of solid per 100 grams of the high protein liquid nutritional composition. As a percentage, in specific embodiments the high protein liquid nutritional composition comprises from about 10% to about 45% of total solids, or from about 20% to about 35% total solids, or from about 25% to about 30% total solids.

[0042] In specific embodiments, the high protein nutritional composition comprises a total solids level from about 20% to about 45%. In specific embodiments, the high protein nutritional composition comprises a solids level from about 25% to about 40%, or a solids level from about 30% to about 35%.

Optional Ingredients

[0043] The nutritional compositions described herein may further comprise other optional ingredients that may modify the physical, chemical, hedonic or processing characteristics of the products 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 products 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.

[0044] Non-limiting examples of such optional ingredients include preservatives, antioxidants, emulsifying agents, buffers, pharmaceutical actives, additional nutrients as described herein, colorants, flavors, thickening agents and stabilizers, and so forth.

[0045] The nutritional compositions may further comprise vitamins or related nutrients, non- limiting examples of which include vitamin A, vitamin E, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B 12, carotenoids, niacin, folic acid, pantothenic acid, biotin, vitamin C, choline, inositol, salts, and derivatives thereof, and combinations thereof. [0046] The nutritional compositions may further comprise minerals, non-limiting examples of which include phosphorus, calcium, magnesium, iron, zinc, manganese, copper, sodium, potassium, molybdenum, chromium, selenium, chloride, and combinations thereof.

[0047] The nutritional compositions may also include one or more masking agents to reduce or otherwise obscure the development of any residual bitter flavors and after taste in the

compositions over time. Suitable masking agents include natural and artificial sweeteners, sodium sources such as sodium chloride, and hydrocolloids, such as guar gum, xanthan gum, carrageenan, gellan gum, and combinations thereof. The amount of masking agent in the nutritional compositions may vary depending upon the particular masking agent selected, other ingredients in the formulation, and other formulation or product target variables. Such amounts, however, most typically range from at least about 0.1%, including form about 0.15% to about 3.0%, and also including from about 0.18% to about 2.5%, by weight of the nutritional compositions.

Heating Processes

[0048] The high protein nutritional composition can be sterilized using heat treatment, which, for example, can be performed using retort or aseptic methods. The term "retort" refers to the filling of a container, for example a metal can or package, with a liquid nutritional composition and then subjecting the can or the liquid-filled package to a heat sterilization step to form a sterilized, retort packaged, liquid nutritional product.

[0049] The term "aseptic" refers to the manufacture of a packaged product without reliance upon the above-described retort packaging step, wherein the liquid nutritional composition and package are sterilized separately prior to filling, and then are combined under sterilized or aseptic processing conditions to form a sterilized, aseptically packaged, liquid nutritional product.

[0050] In both aseptic and retort heating processes, such as those employed in sterilization of nutritional compositions, Maillard browning can occur due to the temperatures used in the heating steps, which can include, for example, temperatures from about 80°F to about 220°F. In other, non-limiting examples, the high protein nutritional composition can be treated with heat at a temperature in a range from about 85°F to about 95°F, from about 130°F to about 150°F, from about 165°F to about 185°F, and/or from about 208°F to about 215°F.

Method of Use

[0051] The nutritional compositions described herein are useful to provide supplement, primary, or sole sources of nutrition, and or to provide individuals one or more benefits as described herein. In accordance with such methods, the compositions may be administered orally as needed to provide the desired level of nutrition, most typically in the form of one to two servings daily, in one or two or more divided doses daily, e.g., serving sizes typically ranging from about 100 to about 300 ml, including from about 150 to about 250 ml, including from about 190 ml to about 240 ml, wherein each serving can contain, for example, from about 0.4 to about 3.0 g HMB per serving, or from about 0.75 to about 2.0 g HMB per serving, or about 1.5 g, of HMB per serving.

Example 1

Λ. Maillard Browning Markers as a Measure of High Protein Nutritional Composition

Quality

[0052] Specific examples of the high protein nutritional composition include a combination of oat fiber and soy fiber as insoluble fiber forms, and gum arabic and CMC as soluble fiber forms. As a measure of improvement of the quality of the high protein nutritional compositions, Maillard browning markers were measured in high protein nutritional compositions with these fiber components and in base compositions that did not contain the these fiber components.

[0053] Table 1 illustrates an example base composition having 80 g L of protein.

Table I

[0054] Furosine and blocked lysine are early stage Maillard Browning markers which were measured. Furosine is known to form upon heat treatment and represents the Amadori products from early Maillard reactions in which amino acids react with reducing carbohydrates. Blocked lysine refers to glycated lysine which is unavailable lysine. In the Maillard Reaction, lysine residues in proteins become blocked when they react with reducing sugars such as lactose (see Bhavbhuti M. et al. Comprehensive Reviews in Food Science and Food Safely, 2016, Vol. 15, 206-216)

[0055] Aseptic and retort treated tube feed with fiber components and a base composition were tested for the early stage Maillard browning marker furosine. Furosine, determined by acid hydrolysis and liquid chromatography with UV detection (LC/UV), is illustrated in Table 2, below. Lysine levels have been calculated via previously published calculation methods (see, McEwen J.W., Effect of Carbohydrate DE on Blocked Lysine and Furosine in a Liquid

Nutritional Product, Food Chemistry (2010) Vol. 119, pages 323-327). Generally, blocked lysine levels are approximately 3.1 times the measured furosine levels. Both furosine and blocked lysine were significantly lower in the compositions with fiber components than the compositions without the fiber components.

Table 2

[0056] FIGS. 1 and 2 illustrate visually the data of Table 2. FIG. 1 illustrates in bar graph form furosine in milligrams per 100 grams of protein on the y-axis for each composition on the x-axis. The furosine concentration was 25% to 30% lower when the fiber components were included. FIG. 2 illustrates in bar graph form blocked lysine in milligrams per 100 grams of protein on the y-axis for each composition on the x-axis. Blocked lysine can be estimated from furosine (as approximately 3.1 times the furosine level) as shown in FIG. 2. The comparisons show that the fiber components inhibited Maillard browning, resulting in less glycation of lysine side chains and thereby an increase in available lysine.

[0057] A decrease in a Maillard browning marker level was considered an increase in nutritional composition quality. Compositions with fiber components were considered to have an increased nutritional composition quality versus compositions without the fiber components as the Maillard browning marker levels were lower in the compositions with the fiber components than those compositions without the fiber components.

B. Ionic Calcium as a Measure of High Protein Nutritional Composition Stability

[0058] Ionic calcium was used as a measure of high protein nutritional composition stability. In protein-based emulsions, a lower level of ionic calcium is generally associated with improved physical stability. As shown below in Table 3, ionic calcium has been measured using an ion selective electrode in the high protein nutritional composition that includes the fiber components in the form of a combination oat fiber and soy fiber as insoluble fiber forms, and gum arabic and CMC as soluble fiber forms.

Table 3

[0059] The ionic calcium concentration was lower when fiber was included, for both aseptic (about 10% lower) and retort (about 7% lower) processes. This is an indication that the composition with fiber components is more stable than compositions without the fiber components, in both aseptic and retort production conditions. FIG. 3 visually depicts that data of Table 3

C. Soluble Calcium as a Measure of High Protein Nutritional Composition Stability [0060] Soluble calcium was also used as a measure of high protein nutritional composition stability. In addition to decreasing Maillard browning and decreasing ionic calcium

concentrations, fiber components also decreased soluble calcium. A lower level of soluble calcium is associated with improved composition stability. The example includes fiber components in the form of a combination of oat fiber and soy fiber as insoluble fiber forms, and gum arabic and CMC as soluble fiber forms. Aseptic and retort treated tube feed with fiber components and without the fiber components were then tested for soluble calcium by centrifugation (30, 100 x g 20°C/4h), followed by cresol phthalein coloiimetry of the supernatant. The test results are reported in Table 4, below. The ratios of soluble calcium to calcium HMB monohydrate have been included, calculated on the composition comprising 3.1 g of CaHMB H 2 0 per kg of product.

Table 4

[0061] FIG. 4 visually depicts the soluble calcium data of Table 4. FIG 4 illustrates that soluble calcium was also lower in both aseptic (about 12%) and retort (about 14%) compositions with fiber components than those without the fiber components. The lower ratio improves product stability and reduces the development over time of bitter flavors and aftertastes. D. Quantification of Fiber Components as a Percentage of Total Carbohydrate Content for

Decrease in Mailiard Browning

[0062] In addition to the effects of fiber components on Mailiard browning and nutritional composition stability, a surprising and unexpected result was found relating to the amount of fiber components needed to provide reduced Mailiard browning. Adding fiber at only 6.5% of the total carbohydrate resulted in a 25% to 30% decrease in Mailiard browning. In other words, the fiber components exerted a disproportionate or exponential inhibitory effect on protein glycation (Mailiard browning). The same beneficial effect was observed in compositions regardless of the heating process, i.e., by retort or aseptic processes. The carbohydrate ingredients of the compositions are specified in Table 5, below. The furosine concentrations determined in these batches are shown for comparison. The furosine concentration was 26% to

27% lower when fiber was added, even though the fiber components comprised only 6.5% of total carbohydrate. In specific embodiments, the carbohydrate concentration of the nutritional composition is in a range from about 5% to about 40%, or from about 7% to about 30%, or from about 10% to about 25%, by weight of the nutritional composition.

[0063] Also as can be seen in Table 5, the aseptic composition with fiber components includes an oat fiber concentration of 5.4 g kg, a soy fiber concentration of 4.5 g/kg, a gum arabic concentration of 2.1 g/kg, and a CMC (in Table 5 TICALOSE® CMC 15F) concentration of 0.9358 g/kg, based on the weight of the nutritional composition. The total of these components, for a 1 kg composition example, would be 12.9358 g, which is about 6.5% of the total carbohydrate content of the high protein nutritional composition (198.36 g) when calculated to include the carbohydrate ingredients of Table 5. FIG. 5 visually depicts data of Table 5, illustrating via a bar graph the substantial and surprising beneficial effect of fiber components on Mailiard browning inhibition. Table 5

'Components which differ between the tested compositions

[0064] The examples and specific embodiments set forth herein are illustrative in nature only and are not to be taken as limiting the scope of the invention defined by the following claims. Additional specific embodiments and advantages of the present invention will be apparent from the present disclosure and are within the scope of the claimed invention.