Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
  • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23D—EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS, COOKING OILS
  • A23D7/00—Edible oil or fat compositions containing an aqueous phase, e.g. margarines
  • A23D7/005—Edible oil or fat compositions containing an aqueous phase, e.g. margarines characterised by ingredients other than fatty acid triglycerides
  • A23D7/0053—Compositions other than spreads
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
  • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
  • A23L33/16—Inorganic salts, minerals or trace elements
  • A23L33/165—Complexes or chelates
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
  • A23L33/17—Amino acids, peptides or proteins
  • A23L33/19—Dairy proteins
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
  • A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P3/00—Drugs for disorders of the metabolism
  • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
  • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Definitions

• the present invention relates to nutritional emulsions having a low viscosity and high fiber concentrations.
• emulsions suitable for oral administration to humans as a sole or supplemental nutrition source.
• These emulsions are typically manufactured as oil-in-water emulsions comprising fat, protein, carbohydrate, vitamins, and minerals. Examples of such emulsions include ENSURE® Nutritional Liquid and GLUCERNA® Shake available from Abbott Laboratories, Columbus, Ohio USA.
• a first embodiment of the nutritional emulsions comprises fat, protein, and carbohydrate, and include (a) from 1.75% to about 4.0% by weight of a diacylglycerol oil; (b) from about 0.5% to about 9.0% by weight of a milk protein concentrate; (c) from about 2.0% to about 9.0% by weight of fiber; and (d) fructose and at least about 0.15% of leucrose in a weight ratio of fructose to leucrose of at least 2:1, wherein the emulsion has a viscosity of less than about 300 cps.
• a second embodiment of the nutritional emulsions comprise from about 5% to about 40% by weight of carbohydrate, from about 2% to about 30% by weight of fat, and from about 0.5% to about 15% by weight of protein, wherein the emulsion includes: (a) from about 1.75% to about 4.0% by weight of a diacylglycerol oil; (b) from about 0.5% to about 9.0% by weight of a milk protein concentrate; (c) from about 2.0% to about 9.0% by weight of fiber; (d) fructose and from about 0.15% of leucrose in a weight ratio of fructose to leucrose of at least 2:1; and (e) from about 0.0020% to about 0.00010%, of chromium picolinate by weight of the emulsion, wherein the aqueous emulsion has a viscosity of less than about 300 centipoise at 20 0 C.
• These nutritional compositions are aqueous oiMn-water emulsions that, despite the high fiber content, have desirable physical and chemical stability under varied conditions, and desirable hedonics, rheologies, and product performance, including a blunted glycemic response profile and or minimal or no gastrointestinal intolerance.
• the emulsions are especially useful when contained within a package having a majority interior surface in contact with the nutritional emulsion that is plastic rather than metal, glass, or other non-plastic surface.
• Figure 1 is a graph from Study 1 illustrating fasting plasma insulin concentrations (mmole/L) at 0, 14 and 28 days in Zucker fa/fa rats fed diets supplemented with A1 , A2 and A3 formulations.
• FIG. 1 is a graph from Study I illustrating differences in insulin sensitivity as determined by an insulin tolerance test (changes in blood glucose at defined times post gavage) for Zucker fa/fa rats supplemented with A1 , A2 and A3 formulations.
• FIG. 3 is a graph from Study I illustrating glycated hemoglobin (%) at 0 and 28 days in Zucker fa/fa rats fed diets supplemented with A1 , A2 or A3 formulations. The change in glycated hemoglobin from day 0 to day 28 is indicated by the upper section of each charted bar.
• FIG. 4 is a graph from Study Il illustrating fasting plasma insulin concentrations (p mol/L) at 0, 14 and 28 days in Zucker fa/fa rats fed a Study Diet or the Study Diet voluntarily supplemented with the A1 formulation.
• the graph shows that voluntary consumption of the A1 formulation attenuated the increase in plasma insulin seen in the control group (*: p ⁇ 0.05).
• Figure 5 is a graph from Study Il illustrating blood glucose (mg/dl) levels at 0, 30, 60, 90, and 120 minutes post insulin injection in Zucker fa/fa rats fed either a Study Diet or the Study Diet voluntarily supplemented with the A1 formulation (p ⁇ 0.05).
• FIG. 6 is a graph from Study Il illustrating glycated hemoglobin (%) in Zucker fa/fa rats at day 0 and 28 of the study in which the rats are fed either a Study Diet or the Study Diet voluntarily supplemented with the A1 formulation.
• the upper section of the bar is the change in glycated hemoglobin from day 0 to day 28 of the study. Voluntary consumption of the A1 formulation attenuated the increase in glycated hemoglobin seen in the unsupplemented group
• Figure 7 is a graph from Study III that shows the total food intake (kcals) by Zucker fa/fa rats fed either a control chow or a semi-purified diet (Study Diet) suggesting a preference for the more palatable Study Diet.
• Figure 8 is a graph from Study III that shows cumulative food intake (kcal) by Zucker fa/fa rats fed a Study Diet alone or the Study Diet supplemented with the A1 formulation. The graphs shows that the animals rats chose to decrease consumption of the palatable, preferred study diet to compensate for the calories they consumed as A1 formulation (p ⁇ 0.05).
• the high fiber nutritional emulsions may comprise various combinations of diacylglycerol oil, fiber, fructose and leucrose, milk protein concentrate, and glycerin, as well as other optional or other components.
• diacylglycerol oil may comprise various combinations of diacylglycerol oil, fiber, fructose and leucrose, milk protein concentrate, and glycerin, as well as other optional or other components.
• the essential features of the nutritional emulsions, as well as some of the many optional variations, are described in detail hereafter.
• nutritional emulsion as used herein, unless otherwise specified, means an aqueous emulsion suitable for oral administration to a human and comprising fat, protein, carbohydrates.
• fat and oil as used herein, unless otherwise specified, are used interchangeably to refer to lipid materials derived or processed from plants or animals.
• high fiber 9 as used herein, unless otherwise specified, means a fiber concentration of from about 1.5% to about 9%, more typically from about 2.3% to about 9%, by weight of a nutritional emulsion.
• heteros as used herein, unless otherwise specified, may refer to one or more of the following properties of the nutritional emulsions: aroma, mouth feel, texture, taste, and color or physical appearance.
• rheologies as used herein, may refer to the desirable viscoelastic properties of the nutritional emulsion, including those under varied conditions such as increased or decreased storage temperatures, to reflect, among other features, the enhanced emulsion and or suspension stability of the nutritional emulsions.
• product performance may refer to the desirable benefits of the packaged nutritional emulsions described herein, wherein such benefits include one or more of increased gastrointestinal tolerance, desirably blunted glycemic response at varied times and under specified circumstances, increased insulin sensitivity, blunted glycemic response to a meal, and desirable product package interactions.
• any reference to a singular characteristic or feature shall include the corresponding plural characteristic or feature, and vice versa, unless otherwise specified.
• the various embodiments of the nutritional emulsions may be substantially free of any specific ingredient described herein, provided that the remaining nutritional emulsion comprises all of the essential limitations described herein.
• the term "substantially free” means the compositions comprise less than a functional amount of the identified ingredient disclosed herein, typically less than about 1.0%, including less than about 0.5%, also including less than about 0.1%, and also including zero percent, by weight of the identified ingredient
• the various embodiments of the nutritional emulsions may comprise, consist of, or consist essentially of any of the essential features or ingredients described herein, as well as any additional or optional features or ingredients described herein or otherwise useful in a nutritional emulsion.
• Numerical ranges as used herein are intended to include every number and subset of numbers contained within that range, whether specifically disclosed or not. Further, these numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range. For example, a disclosure of from 1 to 10 should be construed as supporting a range of from 2 to 8, from 3 to 7, from 5 to 6, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth.
• the nutritional emulsions are aqueous systems in the form of oil-in-water, water-in-oil, or complex emulsions, although most typically the emulsions are oil-in- water emulsions having a continuous aqueous phase and a discontinuous oil phase. Water content varies among the emulsions but most typically ranges from about 70% to about 90%, more typically from about 75% to about 85%, by weight of the emulsions.
• the nutritional emulsion have a drinkable viscosity at room temperature and or when chilled prior to consumption.
• the emulsions may therefore have a viscosity as measured at room temperature (20° C) of less than about 300 cps, typically from about 10 cps to about 160 cps, and more typically from about 20 cps to about 70 cps.
• the nutritional emulsions 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 emulsion for use in individuals afflicted with specific diseases or conditions such as, for example, diabetes or other abnormal glucose tolerance conditions.
• These nutritional emulsions may also have a product density of greater than about 1.055 g/mL, including from 1.06 g/ml to 1.08 g/ml.
• the nutritional emulsions may be retort or aseptically packaged in a suitable glass, plastic, metal, or other container, although it has been found advantageous to formulate with a plastic or other non-metal and non-glass container or package having a plastic interior surface in contact with the emulsions, which plastic interior surface represents a majority of the interior surface area of the container or package.
• These packages are particularly useful when used with the emulsions and subjected to retort sterilization and packaging.
• the nutritional emulsions may comprise a diacylglycerol oil as defined herein.
• diacylglycerol oil concentrations range from at least about 1%, including from about 1.75% to about 4%, and also including from about 1.8% to about 3%, and also including from about 1.9% to about 2.7%, by weight of the emulsion.
• diacylglycerol oil is an art recognized term and as used herein refers to a processed oil comprising from about 60% to 100%, including from about 70% to about 85%, by weight of a diglyceride.
• the diacylglycerol oil may represent from about 10% to 100%, including from about 40% to about 80%, and also including from about 50% to about 70%, by weight of the fat in the emulsion
• Diacylglycerol oils are well known in the nutrition arts and typically comprise a blend of monoglycerides, diglycerides, and triglycerides, wherein the diglycerides represent a majority of the glycerol esters therein. These oils are typically processed vegetable oils such as soy and or cocoa oils comprising about 80% by weight of diglycerides and about 20% by weight of other glycerol esters, i.e., triglycerides and monoglycerides.
• the diglycerides may comprise C16-24 fatty acid esters, including C 16-20 fatty acid esters, most typically esters of oleic, linoleic and or linolenic acid.
• a non limiting example of a diacylglycerol oil suitable for use herein is Enova® Oil, available from Kao Health and Nutrition, Itasca, Illinois, USA. (0041) Although the nutritional emulsions may comprise any of a variety of natural oils, most or all of which comprise a minor amount of diacylglycerol esters (diglycerides), these natural oils do not contain sufficient relative amounts of diglycerides to represent the diacylglyerol oil component of the emulsions herein.
• the nutritional emulsions may further comprise lecithin in combination with the diacylglycerol oil.
• Lecithin concentrations may range from at least about 0.1%, including from about 0.16% to about 0.5%, by weight of the emulsion.
• the diacylglycerol component may be replaced and the desired physical stability of the formulations described herein maintained with an oil blend comprising from 30 to 50%, high oleic safflower oil, from 20 to 40% Canola oil, from 15 to 35% soy oil, and 1 to 10% lecithin, all by weight of the oil blend, including a blend of 40/30/25/5 of these oils, respectively.
• the replacement blend may be used at the same concentrations by weight of the finished nutritional emulsion described herein for the diacylglycerol component
• the nutrition emulsions comprise fiber at levels representing at least about 1.5%, including from about 2.0% to about 9%, and also including from about 2.1% to about 6%, and also including from about 2.2% to about 4.3%, by weight of the emulsions.
• the fiber may represent from about 10% to 100%, including from about
• the fiber as used herein refers generally to those components of a nutritional product that are not absorbed by the body or not otherwise broken down by enzymes in the human digestive tract to small molecules and then absorbed.
• the fiber may include any known fiber or fiber source suitable for oral administration in a nutritional product, including fiber or sources thereof that are soluble and or insoluble, fermentable or non fermentable, or combinations or variations thereof.
• Fiber for use herein may be divided into soluble and insoluble types based on the fiber's capacity to be solubilized in a buffer solution at a defined pH. Fiber sources differ in the amount of soluble and insoluble fiber they contain. As used herein, unless otherwise specified, soluble and insoluble fiber designations and concentrations or amounts thereof and including total fiber concentrations are determined using Association of Official Analytical Chemists (AOAC) Method 991.43.
• AOAC Association of Official Analytical Chemists
• Non limiting examples of soluble dietary fiber or fiber sources for use herein include gum arabic. sodium carboxymethylcellulose, guar gum, citrus pectin, low and high methoxy pectin, oat and barley glucans, carrageenan and psyllium. Numerous commercial sources of soluble dietary fibers are available. For example, gum arabic, hydrolyzed carboxymethylcellulose, guar gum, pectin and the low and high methoxy pectins are available from TIC Gums, Inc. of Belcamp, Maryland. The oat and barley glucans are available from Mountain Lake Specialty Ingredients, Inc. of Omaha, Kansas. Psyllium is available from the Meer Corporation of North Bergen, New Jersey while the carrageenan is available from FMC Corporation of Philadelphia, Pennsylvania.
• Non limiting examples of insoluble dietary fiber or fiber sources for use herein include oat hull fiber, pea hull fiber, soy hull fiber, soy cotyledon fiber, sugar beet fiber, cellulose and com bran. Numerous sources for the insoluble dietary fibers are also available.
• the com bran is available from Quaker Oats of Chicago, Illinois; oat hull fiber from Canadian Harvest of Cambridge, Minnesota; pea hull fiber from Woodstone Foods of Winnipeg, Canada; soy hull fiber and oat hull fiber from The Fibrad Group of LaVaIe 1 Maryland; soy cotyledon fiber from Protein Technologies International of St Louis, Missouri; sugar beet fiber from Delta Fiber Foods of Minneapolis, Minnesota and cellulose from the James River Corp. of Saddle Brook, New Jersey.
• the fiber for use herein may also include fructooligosaccharides (FOS), including those having a degree of polymerization of from 2 to 10, most typically from 3-7, and or inulin, including inulin having a degree of polymerization of at least 10, including from about 20 to about 50, and or a glucooligosaccharides (GOS).
• FOS, GOS 1 and or inulin may represent from zero to about 50%, including from about 5% to about 30%, including from about 10% to about 20%, by weight of the fiber in the nutritional emulsion.
• the fiber content of FOS may be determined in accordance with Association of Official Analytical Chemists (AOAC) Method 997.08 or otherwise assumed to be about 96% by weight of the FOS.
• AOAC Association of Official Analytical Chemists
• Fibersol- 2TM a soluble fiber source comprising about 37% by weight of dietary fiber, which is available from ADM Company, Decatur, Illinois, USA.
• the nutritional emulsions may also comprise a weight ratio of the fiber to the diacylglycerol oil of at least about 1.20:1, including from about 1.23:1 to about 5:1, and also including from about 1.24:1 to about 1.8:1.
• the nutritional emulsions may comprise relatively low sugar concentrations ranging from zero to about 2.1%, including from about 0.5% to about 1.8%, and also including tram about 0.9% to about 1.7%, by weight of the emulsion.
• the emulsions may also have a high fiber to sugar ratio of greater than about 1:1, including from about 20:1 to about 1:1, and also including from about 3:1 to about 1.4:1.
• sucrose refers to the total sum of mono and disaccharides in the emulsions.
• the total carbohydrate to sugar ratio in the nutritional emulsions may range from at least about 5:1 , including from about 5.5:1 to about 20:1 , including from about 6:1 to about 10:1, and also including from about 7:1 to about 9:1.
• the nutritional emulsions may further comprise artificial sweeteners such as saccharin, aspartame, sucralose, neotame, acesulfame potassium, or combinations thereof.
• artificial sweeteners such as saccharin, aspartame, sucralose, neotame, acesulfame potassium, or combinations thereof.
• the ratio of the artificial sweeteners to sugar may range from at least about 0.0060:1, including from about 0.0070:1 to about 0.0300:1, including from about 0.0080:1 to about 0.0095:1.
• the nutritional emulsions may also comprise glycerin as a sweetening agent, which may be used in combination with sugar (at low sugar concentrations described herein) and the artificial sweeteners in the artificial sweetener to sugar ratios as described herein.
• glycerin as a sweetening agent, which may be used in combination with sugar (at low sugar concentrations described herein) and the artificial sweeteners in the artificial sweetener to sugar ratios as described herein.
• the nutritional emulsions may comprise milk protein concentrate (MPC), which may represent some or all of the protein in the emulsions.
• MPC milk protein concentrate
• the emulsions may comprise MPC at concentrations of at least about 0.5%, including from about 1% to about 9%, and also including from about 2% to about 6%, by weight of the emulsions.
• Suitable milk protein concentrates for use herein include any such concentrate that is suitable for use in an oral nutritional product.
• milk protein concentrate 0 refers to bovine milk products having a protein content that typically represents from about 40% to about 88%, including from about 60% to about 80%, and also including from about 65% to about 75%, by weight of the milk product.
• Milk protein concentrates also typically comprise minor amounts of lactose and milk fat
• the nutritional emulsions may comprise glycerin, concentrations of which may represent from about 2.0% to about 6.0%, including from about 2.1% to about 4.0%, and also including from about 2.2% to about 3.0%, by weight of the nutritional emulsion.
• Suitable glycerin sources include any glycerin product suitable for use in an oral nutritional product.
• the nutritional emulsions may comprise a combination of fructose and leucrose, wherein the leucrose represents at least about 0.15% by weight of the nutritional emulsion, including from about 0.15% to about 1.0%, and also including from about 0.30% to about 0.40%, by weight of the nutritional emulsion., wherein the weight ratio of fructose to leucrose is at least about 1.5:1. including from about 2:1 to about 20:1, and also including from about 2.8:1 to about 8:1.
• the fructose and leucrose may be added individually or in combination to the nutritional emulsion.
• a commercial source of one such combination is available from Cargill Sweetener Solutions, Minneapolis, Minnesota, USA, as Cargill's Sucromalt SM05 syrup which includes on a dry weight basis about 37% fructose, 13% leucrose, 48% saccharides and 2% other disaccharides.
• the nutritional emulsions may comprise chromium picolinate at concentrations suitable for oral administration. Such concentrations may range from at least about 0.002%, including from about 0.0020% to about 0.00010%, and also including from about 0.0010% to about 0.00040%, and also including from about 0.00090% to about 0.00060%, by weight of the emulsion.
• Chromium picolinate may be formulated into the nutritional emulsions described herein to assist in blood glucose control when used in combination with the other nutrients described herein.
• the nutritional emulsions comprise fat, protein, and carbohydrate.
• any source of fat, protein, and carbohydrate that is known or otherwise suitable for use in an oral nutritional product is also suitable for use herein, provided that such nutrients are also compatible with the other selected ingredients in the formulation.
• Carbohydrate concentrations most typically range from about 5% to about 40%, including from about 7% to about 30%, including from about 10% to about 25%, by weight of the nutritional emulsion; fat concentrations most typically range from about 2% to about 30%, including from about 3% to about 15%, and also including from about 5% to about 10%, by weight of the nutritional emulsion; and protein concentrations most typically range from about 0.5% to about 30%, including from about 1% to about 15%, and also including from about 2% to about 10%, by weight of the nutritional emulsion.
• Non-limiting examples of suitable fats or sources thereof for use in the nutritional emulsions described herein include diacylglycerol oil as described herein, lecithin as described herein, coconut oil, fractionated coconut oil, soy oil, com oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm and palm kernel oils, palm olein, canola oil, marine oils, cottonseed oils, and combinations thereof.
• Non-limiting examples of suitable carbohydrates or sources thereof for use in the nutritional emulsions described herein may include maltodextrin, hydrolyzed or modified starch or cornstarch, glucose polymers, com syrup, com syrup solids, rice- derived carbohydrates, glucose, fructose, lactose, high fructose com syrup, honey, sugar alcohols (e.g., maltitol, erythritol, sorbitol), and combinations thereof.
• Non-limiting examples of suitable protein or sources thereof for use in the nutritional emulsions 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, com), vegetable (e.g., soy) or combinations thereof.
• suitable proteins or protein sources thereof for use in the nutritional emulsions 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, com), vegetable (e.g., soy) or combinations thereof.
• suitable proteins or protein sources thereof include milk protein isolates, milk protein concentrates as described herein, casein protein isolates, whey protein, caseinates,
• the nutritional emulsion 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.
• optional ingredients are known or otherwise suitable for use in other nutritional products and may also be used in the nutritional emulsions 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.
• 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 (e.g., carrageenan, avicel), sterols, phytosterols, turmeric, lubricants and so forth.
• the nutritional emulsions may further comprise vitamins or related nutrients, non-limiting examples of which include vitamin A, vitamin D, vitamin E, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B12, carotenoids, niacin, folic acid, pantothenic acid, biotin, vitamin C, choline, inositol, salts, and derivatives thereof, and combinations thereof.
• vitamins or related nutrients non-limiting examples of which include vitamin A, vitamin D, vitamin E, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B12, carotenoids, niacin, folic acid, pantothenic acid, biotin, vitamin C, choline, inositol, salts, and derivatives thereof, and combinations thereof.
• the nutritional emulsion may further comprise minerals, non-limiting examples of which include calcium, phosphorus, magnesium, iron, zinc, manganese, copper, sodium, potassium, molybdenum, chromium, selenium, chloride, and combinations thereof.
• the nutritional emulsions may be manufactured by any conventional or otherwise known method for making nutritional emulsions, most typically for making nutritional aqueous emulsions or milk based emulsions.
• two or more separate slurries are prepared, one of which is an aqueous slurry that is substantially free of fat.
• One or more additional slurries may include a protein in a fat/oil slurry (e.g., protein, fat, emulsifier or surfactant, etc.) a protein in water slurry (e.g., protein in water), and additional carbohydrate-mineral slurries.
• the multiple slurries are eventually combined together in a blend tank, subjected to ultra high temperature processing, homogenized, infused with added vitamins, minerals, or other optional ingredients, and diluted with water as appropriate.
• the manufacturing processes may further include packaging the resulting nutritional emulsion in a suitable container that may either be, for example, metal, glass or plastic, and may be re-closeable.
• the method may also further include exposing the packaged nutritional emulsion to retort sterilization to produce a retort packaged nutritional emulsion.
• Retort sterilization is a process step well known to one of ordinary skill in the formulation art, which typically involves high temperature treatment of a packaged liquid nutritional.
• the nutritional emulsion may also be aseptically packaged rather than retort sterilized.
• the certain combinations of components as disclosed and described herein may provide unexpected benefits to the high fiber nutritional emulsions.
• One or more of these unexpected benefits may be the result of a synergistic combination of two or more the components described herein.
• One or more of the combination of specific components described herein may impart improved and unexpected characteristics to the high fiber emulsions as compared to conventional nutritional emulsions.
• the combination of components in the high fiber emulsion may provide an improved glycemic response in combination with a higher caloric content.
• the combination of components in the high fiber emulsion may provide a highly stable high fiber emulsion that can be manufactured using more desirable, low-temperature processing, despite the high fiber content.
• the components of the high fiber emulsion may provide improved hedonics and improved gastrointestinal tolerance while providing high fiber, higher calories, and an improved blunted glycemic response.
• Novel component blends utilized in the high fiber emulsions described herein may include any combination of any two, three, four, five or more of the following components, which may each individually or in combination (even synergistic combination) contribute to the surprising benefits of the high fiber emulsions described above: diacylglycerol oil, milk protein concentrate, sucromalt, fiber, fructooligosaccharides, insoluble fiber, turmeric, glycerin, chromium picolinate, monounsaturated fatty acids having from 16-24 carbon atoms, leucrose, and fructose. That is, any one of these components may be combined with any one or more of the other components and may provide surprising benefits to the resulting high fiber emulsion.
• E XAMPLES
• the formulations are prepared by conventional methods by combining the appropriate ingredients into a separate carbohydrate-mineral slurry, a separate protein-in-water slurry, and a separate protein-in-oil slurry.
• the ingredients are mixed together under temperature and shear appropriate for the selected materials, after which the different slurries are combined in an blend tank, subjected to ultra high temperature treatment (UHT) and then homogenized at about 3000 psi. Vitamins, flavors and other heat-sensitive materials are then added to the homogenized mixture.
• UHT ultra high temperature treatment
• Vitamins, flavors and other heat-sensitive materials are then added to the homogenized mixture.
• the resulting mixture is diluted with water as needed to achieve the desired concentrations and density ( ⁇ 1.0628 g/mL).
• the resulting nutritional emulsion is then sterilized and retort packaged into 8 oz plastic bottles.
• the selected bottles have narrow neck portions extending from 1-5 cm from the broader package body.
• compositions when packaged provide desirable features, including one or more desirable features such as physical or chemical or emulsion stability, desirable hedonics, favorable rheology or viscoelastic properties, and product performance as defined herein.
• the formulations are physically stable when packaged and stored for up to 18 months at 20 0 C and provide a blunted glycemic response with minimal or no gastrointestinal intolerance, especially when used in diabetics or other individuals in whom such a blunted glycemic response would be beneficial.
• Soluble fiber source 37% by weight of dietary fiber; ADM Company, Decatur. Illinois USA
• A1 an embodiment of the present invention is evaluated for insulin sensitivity benefits relative to separate controls (A2 and A3).
• A1 is a balanced nutritional formulation of the present invention and is compared to formulations A2 (Carb-Chromium) and A3 (carb-protein-chromium) which contain only selected components of A1 and do not contain the requisite balanced formulation required of the present invention.
• A1 is a balanced nutritional embodiment of the present invention.
• A2 is a solution comprising the functional carbohydrates and chromium picolinate of A1.
• A3 is a solution comprising the functional carbohydrates, chromium and proteins of A1. Both of the A2 and A3 solutions are prepared so the rats consume the levels of functional carbohydrates (Fibersol, Sucromalt and Glycerol) (2.83kcals/gram) and proteins (milk protein concentrate and soy protein concentrate) (3.46 kcals/gram) found in the A1 formulation.
• functional carbohydrates Fibersol, Sucromalt and Glycerol
• proteins milk protein concentrate and soy protein concentrate
• Supplement compositions do not affect fasting blood glucose concentration over the 28 day feeding period. Surprisingly, A3 and A2 increase plasma insulin compared to A1 (see Fig. 1 ; p ⁇ 0.01 on day 14 for A2 vs. A1 ). A3 significantly worsens insulin sensitivity compared to A1 (see Fig. 2). A2 supplementation magnifies the increase in glycated hemoglobin 0.9% from Day 0 to Day 28 compared to 0.2% for A1 (Fig. 3).
• the study diet increased food intake and body weight compared to control chow (p ⁇ 0.05, see Fig 7). This shows that the high fat, high sucrose study diet is preferred compared to the regular chow diet, suggesting that the rats found it highly palatable.
• rats When offered access to the A1 formulation, however, rats voluntarily consumed about 1000 kcal over the course of the study. Surprisingly, rats chose to decrease consumption of the palatable, preferred study diet to compensate for the calories they consumed as A1 formulation (p ⁇ 0.05; see Fig. 8). This suggests that the A1 formulation is surprisingly palatable and satiating, causing rats to reduce intake of a preferred solid diet.

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