WO2022266058A1 - Procédés et compositions pour le traitement des gaz - Google Patents

Procédés et compositions pour le traitement des gaz Download PDF

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Publication number
WO2022266058A1
WO2022266058A1 PCT/US2022/033376 US2022033376W WO2022266058A1 WO 2022266058 A1 WO2022266058 A1 WO 2022266058A1 US 2022033376 W US2022033376 W US 2022033376W WO 2022266058 A1 WO2022266058 A1 WO 2022266058A1
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WO
WIPO (PCT)
Prior art keywords
nutritional composition
fucosyllactose
sialyllactose
nutritional
human milk
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Application number
PCT/US2022/033376
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English (en)
Inventor
David Hill
Rachael Buck
Original Assignee
Abbott Laboratories
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Publication of WO2022266058A1 publication Critical patent/WO2022266058A1/fr

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    • 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
    • A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
    • 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
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health
    • A23V2200/31—Foods, ingredients or supplements having a functional effect on health having an effect on comfort perception and well-being
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health
    • A23V2200/32—Foods, ingredients or supplements having a functional effect on health having an effect on the health of the digestive tract
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health
    • A23V2200/32—Foods, ingredients or supplements having a functional effect on health having an effect on the health of the digestive tract
    • A23V2200/3202—Prebiotics, ingredients fermented in the gastrointestinal tract by beneficial microflora
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health
    • A23V2200/32—Foods, ingredients or supplements having a functional effect on health having an effect on the health of the digestive tract
    • A23V2200/3204—Probiotics, living bacteria to be ingested for action in the digestive tract
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2250/00—Food ingredients
    • A23V2250/28—Oligosaccharides
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2400/00—Lactic or propionic acid bacteria
    • A23V2400/21—Streptococcus, lactococcus
    • A23V2400/249—Thermophilus
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2400/00—Lactic or propionic acid bacteria
    • A23V2400/51—Bifidobacterium
    • A23V2400/529—Infantis
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2400/00—Lactic or propionic acid bacteria
    • A23V2400/51—Bifidobacterium
    • A23V2400/531—Lactis

Definitions

  • the present disclosure generally relates to methods and compositions for treating gas in an individual. More particularly, the present disclosure relates to a nutritional composition that includes a mixture of human milk oligosaccharides and a probiotic blend that is useful for treating gas in an individual.
  • the nutritional compositions include a mixture of human milk oligosaccharides and a probiotic blend.
  • a method of treating gas in an individual includes administering to the individual a nutritional composition comprising: a) a mixture of human milk oligosaccharides comprising a neutral human milk oligosaccharide and an acidic human milk oligosaccharide; and b) a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium irfantis , and Streptococcus thermophilus.
  • the present disclosure also provides a nutritional composition for use in treating gas in an individual, the nutritional composition comprising: a) a mixture of human milk oligosaccharides comprising a neutral human milk oligosaccharide and an acidic human milk oligosaccharide; and b) a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • the present disclosure also provides use of a mixture of human milk oligosaccharides and a probiotic blend for the manufacture of a medicament for treating gas in an individual, wherein the mixture of human milk oligosaccharides comprises a neutral human milk oligosaccharide and an acidic human milk oligosaccharide, and the probiotic blend comprises Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • a method of treating fussiness due to gas in an infant includes administering to the infant a nutritional composition comprising: a) a mixture of human milk oligosaccharides comprising a neutral human milk oligosaccharide and an acidic human milk oligosaccharide; and b) a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • the present disclosure also provides a nutritional composition for use in treating fussiness due to gas in an infant, the nutritional composition comprising: a) a mixture of human milk oligosaccharides comprising a neutral human milk oligosaccharide and an acidic human milk oligosaccharide; and b) a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • the present disclosure also provides use of a mixture of human milk oligosaccharides and a probiotic blend for the manufacture of a medicament for treating fussiness due to gas in an infant, wherein the mixture of human milk oligosaccharides comprises a neutral human milk oligosaccharide and an acidic human milk oligosaccharide, and the probiotic blend comprises Bifidobacterium lactis , Bifidobacterium irfantis , and Streptococcus thermophilus.
  • a method of reducing odors associated with gas produced by an individual includes administering to the individual a nutritional composition comprising: a) a mixture of human milk oligosaccharides comprising a neutral human milk oligosaccharide and an acidic human milk oligosaccharide; and b) a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • the gas produced by the individual after administration of the nutritional composition has a reduced amount of odor causing components as compared to gas produced by the individual after administration of an otherwise identical nutritional composition that does not include: i) a mixture of human milk oligosaccharides comprising a neutral human milk oligosaccharide and an acidic human milk oligosaccharide; and ii) a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • the present disclosure also provides a nutritional composition for use in reducing odors associated with gas produced by an individual, the nutritional composition comprising: a) a mixture of human milk oligosaccharides comprising a neutral human milk oligosaccharide and an acidic human milk oligosaccharide; and b) a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • the present disclosure also provides use of a mixture of human milk oligosaccharides and a probiotic blend for the manufacture of a medicament for reducing odors associated with gas produced by an individual, wherein the mixture of human milk oligosaccharides comprises a neutral human milk oligosaccharide and an acidic human milk oligosaccharide, and the probiotic blend comprises Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • FIG. 1 is a bar graph showing the change in in vitro microbiome carbon dioxide (CO2) production associated with five different treatment conditions in accordance with Example 1 of the present disclosure.
  • CO2 in vitro microbiome carbon dioxide
  • the nutritional compositions and methods disclosed herein utilize a mixture of human milk oligosaccharides comprising a neutral human milk oligosaccharide and an acidic human milk oligosaccharide in combination with a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus for treating gas in an individual, as well as for controlling, treating, and/or reducing symptoms and/or conditions associated with excessive gas production in an individual.
  • the nutritional compositions of the present disclosure improve the efficiency of the individual’s gastrointestinal environment in extracting nutrients such that components that would otherwise be broken down or fermented by microbiota of the large intestine to produce gas are more efficiently broken down or fermented by the microbiota to produce less gas or no gas at all.
  • the nutritional compositions of the present disclosure can be administered to an individual to treat gas, as well as to control, treat, and/or reduce symptoms and/or conditions associated with excessive gas production in an individual.
  • fat and oil as used herein, unless otherwise specified, are used interchangeably to refer 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.
  • human milk oligosaccharide refers generally to a number of complex carbohydrates found in human breast milk that can be in acidic or neutral form, and, in certain instances, to precursors thereof.
  • exemplary non- limiting human milk oligosaccharides include neutral oligosaccharides (which include fucosylated oligosaccharides and N-acetylated oligosaccharides ( e.g ., neutral non-fucosylated)) and acidic oligosaccharides (which include sialylated oligosaccharides).
  • HMO blend refers to a combination of neutral and acidic HMOs, which may comprise at least two of 2’-FL, 3-FL, 3’-SL, 6’-SL, LNT, and LNnT.
  • the terms “nutritional formulation” or “nutritional composition” as used herein, are used interchangeably and, unless otherwise specified, refer to synthetic formulas including nutritional liquids, nutritional powders, nutritional solids, nutritional semi-solids, nutritional semi-liquids, nutritional supplements, and any other nutritional food product as known in the art.
  • the nutritional powders may be reconstituted to form a nutritional liquid, all of which comprise one or more of fat, protein and carbohydrate and are suitable for oral consumption by a human.
  • the terms “nutritional formulation” or “nutritional composition” do not include human breast milk and do not refer to supplemented milk, whether of human origin or otherwise.
  • shelf stable refers to a nutritional composition that remains commercially stable after being packaged and then stored at 18-24° C. for at least 3 months, including from about 3 months to about 36 months, including from about 3 months to about 24 months, and also including from about 3 months to about 18 months.
  • nutritional liquid refers to nutritional compositions in ready-to-drink liquid form, concentrated form, and nutritional liquids made by reconstituting the nutritional powders described herein prior to use.
  • nutritional powder refers to nutritional compositions in flowable or scoopable form that can be reconstituted with water or another aqueous liquid prior to consumption and includes both spray-dried and dry-mixed/dry- blended powders.
  • Some semi-solids examples include puddings, gelatins, and doughs.
  • infant refers generally to individuals up to age 36 months of age, actual or corrected and in certain instances may include toddlers. In certain aspects, the term infant refers to individuals up to 12 months of age, actual or corrected.
  • preterm infant refers to those infants bom at less than 37 weeks gestation, have a birth weight of less than 2500 gm, or both.
  • toddler refers to an individual greater than one year of age up to three years of age.
  • child refers to an individual greater than three years of age up to twelve years of age.
  • infant formula or “synthetic infant formula” as used herein, unless otherwise specified, are used interchangeably and refer to liquid, semi-liquid, solid, and semi-solid human milk replacements or substitutes that are suitable for consumption by an infant.
  • infant formula and “synthetic infant formula” do not include human breast milk.
  • synthetic child formula refers to liquid, semi-liquid, solid, and semi-solid human milk replacements or substitutes that are suitable for consumption by a child up to twelve years of age.
  • synthetic child formula does not include human breast milk.
  • preterm infant formula refers to liquid and solid nutritional products suitable for consumption by a preterm infant.
  • preterm infant formula does not include human breast milk.
  • human milk fortifier refers to liquid and solid nutritional products suitable for mixing with breast milk or preterm infant formula or infant formula for consumption by a preterm infant or term infant.
  • a human milk fortifier alone i.e . , when not mixed with breast milk or an infant formula
  • treating includes delaying the onset of a condition, reducing the severity of symptoms of a condition, or eliminating some or all of the symptoms of a condition.
  • treating gas may include a reduction in the amount (e.g ., volume, mass) of intestinal gas produced by an individual.
  • the “reduction” in the amount of intestinal gas produced by an individual is with respect to the amount of intestinal gas produced by the individual after consuming a nutritional composition according to the present disclosure that contains a mixture of HMOs including a neutral HMO and an acidic HMO and a probiotic blend compared to the amount of intestinal gas produced by the individual after consuming an otherwise identical nutritional composition that does not include a mixture of HMOs including a neutral HMO and an acidic HMO and a probiotic blend.
  • concentrations expressed as either “pg/liter,” “mg/liter,” “mg/L,” “g/L,” “mcg/L,” “mg/mL,” etc . refer to ingredient concentrations within the described compositions as calculated on an as-fed basis (e.g ., reconstituted for consumption in the case of nutritional powders), unless otherwise specified.
  • reconstitute or various other forms such as “reconstituted” or “reconstituting” all refer to the general act of adding a suitable amount of liquid, typically water, to a form of a composition that is not in a ready -to-drink liquid form, such as a nutritional powder or a concentrated form of a nutritional liquid, thereby making the composition ready-to-drink.
  • compositions and methods of the present disclosure may comprise, consist of, or consist essentially of the essential elements of the compositions and methods as described herein, as well as any additional or optional element or feature described herein or which is otherwise useful in nutritional composition applications.
  • the nutritional compositions of the present disclosure may be substantially free of any optional or selected ingredient or feature described herein, provided that the remaining nutritional composition or formula still contains all of the required ingredients or features as described herein.
  • the term “substantially free” means that less than a functional amount of the optional or selected ingredient is present, which is typically less than 0.1% by weight, and also including zero percent by weight of such optional or selected ingredient.
  • 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, by-products, or other components that may be included in commercially available materials, unless otherwise specified.
  • Ranges as used herein are intended to include every number and subset of numbers 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 compositions of the present disclosure may be formulated and administered in any known or otherwise suitable oral product form. Any solid, semi-solid, liquid, semi-liquid, or powder product form, including combinations or variations thereof, are suitable for use herein, provided that such forms allow for safe and effective oral delivery to the individual of the essential ingredients and any optional ingredients as also defined herein.
  • the nutritional compositions of the present disclosure include a mixture of HMOs comprising a neutral HMO and an acidic HMO in combination with a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • the nutritional compositions may be formulated with sufficient kinds and amounts of nutrients to provide a sole, primary, or supplemental source of nutrition.
  • the nutritional compositions may be in any product form comprising the ingredients described herein, and which is safe and effective for oral administration.
  • the nutritional compositions may be formulated to include only the ingredients described herein, or may be modified with optional ingredients to form a number of different product forms.
  • the nutritional compositions of the present disclosure are desirably formulated as dietary product forms, which are defined herein as those embodiments comprising the ingredients according to the present disclosure in a product form that then contains at least one of fat, protein, or carbohydrate, and preferably also contains vitamins, minerals, or combinations thereof.
  • the nutritional compositions will comprise at least a mixture of HMOs and a probiotic blend, desirably in combination with at least one of protein, fat, vitamins, or minerals, to produce a nutritional composition.
  • Liquid nutritional compositions include both concentrated and ready-to-feed nutritional liquids. These nutritional liquids are most typically formulated as suspensions or emulsions, although other liquid forms are within the scope of the general inventive concepts.
  • Nutritional compositions in the form of emulsions suitable for use may be aqueous emulsions comprising proteins, fats, and carbohydrates. These emulsions are generally 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.
  • the nutritional liquids may be and typically are shelf stable.
  • the nutritional emulsions typically contain up to about 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 emulsions.
  • the nutritional emulsions may have a variety of product densities, but most typically have a density greater than about 1.03 g/mL, including greater than about 1.04 g/mL, including greater than about 1.055 g/mL, including from about 1.06 g/mL to about 1.12 g/mL, and also including from about 1.085 g/mL to about 1.10 g/mL.
  • the nutritional liquids of the present disclosure include a mixture of HMOs comprising a neutral HMO and an acidic HMO, and are accompanied by a probiotic blend, in powder form, comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus .
  • the probiotic blend is added to and/or mixed with the nutritional liquid prior to consumption.
  • the probiotic blend may be provided along with the nutritional liquid in one or more single serving packets ( e.g ., stick pack).
  • the nutritional liquids of the present disclosure may comprise a kit containing a liquid nutritional composition comprising a mixture of HMOs comprising a neutral HMO and an acidic HMO and one or more single serving packets of a probiotic blend, in powder form, comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • the nutritional liquid compositions may have a caloric density tailored to the nutritional needs of the ultimate user.
  • the liquid nutritional composition when the liquid nutritional composition is formulated for an infant the liquid nutritional composition generally comprises at least 19 kcal/fl oz (about 660 kcal/liter), more typically from about 20 kcal/fl oz (about 675-680 kcal/liter) to about 25 kcal/fl oz (about 820 kcal/liter), even more typically from about 20 kcal/fl oz (about 675-680 kcal/liter) to about 24 kcal/fl oz (800-810 kcal/liter).
  • the 22-24 kcal/fl oz nutritional liquids are more commonly used in preterm or low birth weight infants, and the 20- 21 kcal/fl oz (about 675-680 to 700 kcal/liter) nutritional liquids are more often used in term infants.
  • nutritional liquids formulated for adults may have a caloric density of from about 22 kcal/fl oz (about 743 kcal/liter) to about 44 kcal/fl oz (about 1,500 kcal/liter), including from about 23 kcal/fl oz (about 775 kcal/liter) to about 36 kcal/fl oz (about 1,220 kcal/liter), and also including from about 26 kcal/fl oz (about 880 kcal/liter) to about 32.5 kcal/fl oz (about 1,100 kcal/liter).
  • the nutritional liquids may have a caloric density of 25 kcal/liter, or 50 kcal/liter, or 75 kcal/liter, or 100 kcal/liter.
  • the nutritional liquid compositions may have a pH ranging from about 2.5 to about 8, but are most advantageously in a range of from about 4.5 to about 7.5, including from about 5.5 to about 7.3, including from about 6.2 to about 7.2
  • a typical serving size is generally at least about 1 mL, or even at least about 2 mL, or even at least about 5 mL, or even at least about 10 mL, or even at least about 25 mL, including ranges from about 2 mL to about 300 mL, including from about 4 mL to about 250 mL, and including from about 10 mL to about 240 mL.
  • the nutritional compositions in the form of nutritional solids may be in any solid form but are typically in the form of flowable or substantially flowable particulate compositions, or at least particulate compositions.
  • Particularly suitable nutritional solid product forms include spray dried, agglomerated and/or dry -blended powder compositions.
  • the solid compositions can easily be scooped and measured with a spoon or similar other device, and can easily be reconstituted by the intended user with a suitable aqueous liquid, typically water, to form a nutritional composition for immediate oral or enteral use.
  • “immediate” use generally means within about 48 hours, most typically within about 24 hours, preferably right after reconstitution.
  • the nutritional powders may be reconstituted with water prior to use to a caloric density tailored to the nutritional needs of the ultimate user, similar to that described above for liquid nutritional compositions.
  • HMOs Human Milk Oligosaccharides
  • the nutritional compositions of the present disclosure include a mixture of HMOs comprising a neutral HMO and an acidic HMO.
  • the composition of human milk oligosaccharides is very complex and more than 200 different oligosaccharide structures are known.
  • the mixture of HMOs are included in the nutritional compositions of the present disclosure along with a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • the HMOs may be isolated or enriched from milk(s) secreted by mammals including, but not limited to: human, bovine, ovine, porcine, or caprine species.
  • the HMOs may also be produced via microbial fermentation, enzymatic processes, chemical synthesis, or combinations thereof.
  • Suitable HMOs for use in the nutritional compositions of the present disclosure may include neutral oligosaccharides, n-acetyl glucosylated oligosaccharides, acidic HMOs, and HMO precursors.
  • suitable HMOs that may be included in the nutritional compositions according to the present disclosure include: 2’-fucosyllactose (2’-FL), 3- fucosyllactose (3-FL), 3’-sialyllactose (3’-SL), 6’-sialyllactose (6’-SL), lacto-N-neotetraose (LNnT), and lacto-N-tetraose (LNT).
  • HMOs that may be included in certain aspects of the nutritional compositions of the present disclosure include: N-acetylglucosamine (GlcNAc); L-fucose (L-Fuc); D-fucose (D- Fuc); fucosyl oligosaccharides (i.e., Lacto-N-fucopentaose I; Lacto-N-fucopentaose II; Lacto-N- fucopentaose III; Lacto-N-difucohexaose I; and Lactodifucotetraose); sialyl fucosyl oligosaccharides (i.e., 3'-Sialyl-3-fucosyllactose; Disialomonofucosyllacto-N-neohexaose; Monofucosylmonosialyllacto-N-octaose (sialyl Lea
  • HMOs lacto-N-fucopentaose V, lacto-N- hexaose, para-lacto-N-hexaose, lacto-N-neohexaose, para-lacto-N-neohexaose, monofucosyllacto-N-hexaose II, isomeric fucosylated lacto-N-hexaose (1), isomeric fucosylated lacto-N-hexaose (3), isomeric fucosylated lacto-N-hexaose (2), difucosyl-para-lacto-N- neohexaose, difucosyl-para-lacto-N-hexaose, difucosyllacto-N-hexaose, lacto-N-neoocataose, para-lac
  • the HMOs are present in the nutritional composition, when in liquid form (e.g., ready- to-feed form), in total amounts of HMO in the nutritional composition (mg of HMO per mL of composition) of at least about 0.001 mg/mL to about 20 mg/mL, including about 0.1 mg/mL to about 20 mg/mL, about 1 mg/mL to about 10 mg/mL, about 2 mg/mL to about 10 mg/mL, and also including from about 2.5 mg/mL to about 8.5 mg/mL.
  • the amount of HMO in the nutritional composition will depend on the specific HMO or HMOs present and the amounts of other components in the nutritional compositions.
  • the neutral HMO in the nutritional composition of the present disclosure includes at least one of 2’-FL, 3-FL, LNT, LNnT, and combinations thereof.
  • the amount of neutral HMOs present in the nutritional composition can vary depending on the individual to whom the nutritional composition is administered.
  • the nutritional composition includes a neutral HMO at a concentration of at least 0.02 mg/mL (when the nutritional composition is in ready-to-feed liquid form).
  • the neutral HMOs are present in the nutritional composition at a concentration from about 0.02 mg/mL to about 10 mg/mL, including from about 0.1 mg/mL to about 6 mg/mL, including from about 0.5 mg/mL to about 5.75 mg/mL, including from about 1 mg/mL to about 5.5 mg/mL, including from about 1.25 mg/mL to about 5 mg/mL, including from about 1.5 mg/mL to about 4.75 mg/mL, and also including from about 1.6 mg/mL to about 4.6 mg/mL.
  • the acidic HMO in the nutritional composition of the present disclosure includes at least one of 3’-SL, 6’-SL, and combinations thereof.
  • the amount of acidic HMOs present in the nutritional composition can vary depending on the individual to whom the nutritional composition is administered.
  • the nutritional composition includes an acidic HMO at a concentration of at least 0.02 mg/mL (when the nutritional composition is in ready-to-feed liquid form).
  • the acidic HMOs are present in the nutritional composition at a concentration from about 0.02 mg/mL to about 10 mg/mL, including from about 0.04 mg/mL to about 5 mg/mL, including from about 0.08 mg/mL to about 1 mg/mL, including from about 0.1 mg/mL to about 0.8 mg/mL, including from about 0.12 mg/mL to about 0.75 mg/mL, including from about 0.15 mg/mL to about 0.7 mg/mL, and also including from about 0.2 mg/mL to about 0.65 mg/mL.
  • the nutritional composition of the present disclosure includes at least one of 2’-FL, 3-FL, LNT, and LNnt, and at least one of 3’-SL and 6'-SL in a total amount of HMO of from about 0.001 mg/mL to about 20 mg/mL, including from about 0.01 mg/mL to about 20 mg/mL, about 0.1 mg/mL to about 20 mg/mL, about 0.5 mg/mL to about 20 mg/mL, about 1 mg/mL to about 20 mg/mL, about 2 mg/mL to about 20 mg/mL, about 3 mg/mL to about 20 mg/mL, and also including from about 5 mg/mL to about 20 mg/mL.
  • the nutritional composition of the present disclosure includes at least one of 2’-FL, 3-FL, LNT, and LNnt, and at least one of 3’-SL and 6'-SL in a total amount of HMO of from about 0.1 mg/mL to about 20 mg/mL, including from about 0.1 mg/mL to about 15 mg/mL, including from about 0.1 mg/mL to about 10 mg/mL, including from about 0.1 mg/mL to about 9 mg/mL, including from about 0.1 mg/mL to about 8 mg/mL, including from about 0.1 mg/mL to about 7 mg/mL, including from about 0.1 mg/mL to about 6 mg/mL, including from about 0.1 mg/mL to about 5 mg/mL, including from about 0.1 mg/mL to about 4 mg/mL, including from about 0.1 mg/mL to about 3 mg/mL, including from about 0.1 mg/mL to about 2 mg/mL, including from about 0.5 mg/mL to about 4 mg
  • the nutritional composition includes a neutral HMO comprising a fucosylated HMO and an N-acetylated HMO and an acidic HMO.
  • the nutritional composition comprises a combination of 2’-FL, 3-FL, 3’-SL, 6’-SL, and LNT.
  • the nutritional composition (when in ready -to-feed liquid form) comprises 2’-FL in an amount up to 4.15 mg/mL, LNT in an amount up to 2.11 mg/mL, 3-FL in an amount up to 1.17 mg/mL, 3’-SL in an amount up to 0.36 mg/mL, and 6’-SL in an amount up to 0.44 mg/mL.
  • the nutritional composition of the present disclosure when in powder form, comprises a total amount of HMOs of from about 1 wt% to about 10 wt% based on the total weight of the nutritional composition.
  • the nutritional composition of the present disclosure when in powder form, comprises a total amount of HMOs of from about 1 wt% to about 8 wt% based on the total weight of the nutritional composition, including from about 1.5 wt% to about 7.5 wt%, including from about 2 wt% to about 7 wt%, including from about 2.5 wt% to about 6.5 wt%, and also including from about 3 wt% to about 6 wt% based on the total weight of the nutritional composition.
  • the nutritional compositions of the present disclosure include a probiotic blend.
  • the probiotic blend comprises Bifidobacterium lactis, Bifidobacterium infantis , and Streptococcus thermophilus .
  • the probiotic blend present in the nutritional compositions of the present disclosure optionally include one or more additional probiotic strains.
  • Probiotics are generally understood to be microorganisms with low or no pathogenicity that exert at least one beneficial effect on the health (e.g ., digestive health, immune health) of the host.
  • the probiotic blend may comprise viable microorganisms, non-viable microorganisms, or a combination of viable and non-viable microorganisms.
  • the probiotic blend comprises viable microorganisms.
  • the nutritional composition comprises a probiotic blend in an amount of up to 10 12 colony forming units (CFU) per gram of dry weight of the nutritional composition (e.g ., when a powdered or reconstitutable composition), including in a range from 10 5 CFU/g to 10 12 CFU/g, from 10 6 CFU/g to 10 12 CFU/g, from 10 7 CFU/g to 10 12 CFU/g, from 10 8 CFU/g to 10 12 CFU/g, or from 10 7 CFU/g to 10 8 CFU/g.
  • CFU colony forming units
  • the powdered nutritional composition comprises a probiotic blend in an amount of up to 10 12 CFU/g, including in a range from 10 5 CFU/g to 10 12 CFU/g, from 10 6 CFU/g to 10 12 CFU/g, from 10 7 CFU/g to 10 12 CFU/g, from 10 8 CFU/g to 10 12 CFU/g, or from 10 7 CFU/g to 10 8 CFU/g.
  • the nutritional composition of the present disclosure comprises Bifidobacterium lactis in an amount of 10 5 CFU/g to 10 12 CFU/g, Bifidobacterium infantis in an amount of 10 5 CFU/g to 10 12 CFU/g, and Streptococcus thermophilus in an amount of 10 5 CFU/g to 10 12 CFU/g.
  • the nutritional composition comprises a probiotic blend in a total cell count amount of at least 10 5 CFU per serving, including from 10 5 CFU to 10 12 CFU of a probotic blend per serving.
  • the probiotic blend comprises, per serving, 10 5 CFU to 10 12 CFU of Bifidobacterium lactis , 10 5 CFU to 10 12 CFU of Bifidobacterium infantis , and 10 5 CFU to 10 12 CFU of Streptococcus thermophilus.
  • Exemplary B. lactis probiotic strains suitable for use in the probiotic blend of the present disclosure include, but are not limited to, B. lactis Bi-07, B. lactis BB-12, B.
  • Exemplary B. infantis probiotic strains suitable for use in the probiotic blend of the present disclosure include, but are not limited to, B. infantis M-63, B. infantis ATCC 15697, B. infantis 35624, B. infantis CHCC2228, B. infantis BB-02, B. infantis DSM20088, and B. infantis R0033.
  • Exemplary S. thermophilus probiotic strains suitable for use in the probiotic blend of the present disclosure include, but are not limited to, S. thermophilus APC151, S. thermophilus TH-4, S. thermophilus LMG183 11, A thermophilus CNRZ1066, S. thermophilus LMD-9, S. thermophilus DSM20088, and S. thermophilus R0033.
  • the probiotic blend may optionally include one or more probiotic strains in addition to the B. lactis , B. infantis , and S. thermophilus.
  • the optional probiotic strains that may be used in the probiotic blend include members of the genus Lactobacillus including L. acidophilus, L. acidophilus NCFM, L. amylovorus, L. brevis, L. bulgaricus, L. casei spp. casei, L. casei spp. rhamnosus, L. crispatus, L. delbrueckii ssp. lactis, L.fermentum, L. fermentum CECT5716, L. helveticus, L.
  • additional members of the genus Bifidobacterium including: B. animalis, B. bifidum, B. breve, and B. longum members of the genus Pediococcus including: P. acidilactici ; members of the genus Propionibacterium including: P. acidipropionici, P. freudenreichii, P. jensenii, and P. theonii ; and additional members of the genus Streptococcus including: S. cremoris and S. lactis.
  • the nutritional composition may include one or more sources of dietary fiber.
  • sources of dietary fiber suitable for use in the nutritional composition of the present disclosure include, but are not limited to, fructooligosaccharides (including short-chain fructooligosaccharides), galactooligosaccharides, inulin, polydextrose, 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, arabinoglactins, glucomannan, xanthan gum, alginate, pectin, low methoxy pectin, high methoxy pectin, cereal beta-glucans (e.g.
  • oat beta-glucan barley beta-glucan
  • carrageenan psyllium
  • digestion resistant maltodextrin e.g, FibersolTM, a digestion-resistant maltodextrin, comprising soluble dietary fiber
  • Numerous commercial sources of soluble dietary fibers are available.
  • gum arabic, guar gum, pectin, and 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
  • carrageenan is available from FMC Corporation of Philadelphia, Pennsylvania.
  • the nutritional composition includes at least one of fructooligosaccharides (including short-chain fructooligosaccharides) and galactooligosaccharides as the dietary fiber.
  • fructooligosaccharides including short-chain fructooligosaccharides
  • galactooligosaccharides as the dietary fiber.
  • These oligosaccharides are rapidly and extensively fermented to short-chain fatty acids by anaerobic microorganisms that inhabit the large intestine.
  • These oligosaccharides may be preferential energy sources for certain strains of bacteria that inhabit the large intestine, such as Bifidobacterium species, but are not utilized by potentially pathogenic organisms such as Clostridium perfingens, C. difficile, or Eschericia coli.
  • the nutritional composition includes a blend of dietary fiber comprising fructooligosaccharides (including short-chain fructooligosaccharides), inulin, gum arabic, and digestion resistant maltodextrin (e.g, FibersolTM, a digestion-resistant maltodextrin, comprising soluble dietary fiber).
  • fructooligosaccharides including short-chain fructooligosaccharides
  • inulin including short-chain fructooligosaccharides
  • gum arabic e.g, and digestion resistant maltodextrin (e.g, FibersolTM, a digestion-resistant maltodextrin, comprising soluble dietary fiber).
  • digestion resistant maltodextrin e.g, FibersolTM, a digestion-resistant maltodextrin, comprising soluble dietary fiber.
  • the dietary fiber may be present in any suitable amount.
  • the composition includes dietary fiber in an amount of about 0.5 g/L to about 20 g/L, including from about 1 g/L to about 15 g/L, from about 2 g/L to about 10 g/L, and also including from about 3 g/L to about 6 g/L.
  • the nutritional compositions of the present disclosure will include at least one of protein, fat, or carbohydrate (i.e., a carbohydrate that is not an HMO or a dietary fiber as described above). In many aspects, the nutritional compositions of the present disclosure will include protein, fat, and carbohydrate (i.e., a carbohydrate that is not an HMO or a dietary fiber as described above).
  • the nutritional compositions of the present disclosure may be formulated to contain sufficient kinds and amounts of nutrients to provide a sole, primary, or supplemental source of nutrition.
  • the nutritional compositions of the present disclosure including the mixture of HMOs and the probiotic blend may be formulated to include at least one of protein, fat, or carbohydrate.
  • the nutritional compositions of the present disclosure include a fucosylated HMO, a sialylated HMO, and a probiotic blend with protein, carbohydrate, and fat.
  • total concentrations or amounts of the protein, fat, and carbohydrates may vary depending upon the product type (i.e., nutritional formula), product form (i.e., nutritional solid, powder, ready -to-feed liquid, or concentrated liquid) and targeted dietary needs of the intended user, such concentrations or amounts most typically fall within one of the following embodied ranges, inclusive of any other essential fat, protein, and/or carbohydrate ingredients as described herein.
  • carbohydrate concentrations most typically will range from about 1% to about 40%, including from about 7% to about 30%, including from about 10% to about 25%, by weight of the nutritional composition.
  • fat concentrations most typically range from about 1% to about 30%, including from about 2% to about 15%, and also including from about 3% to about 10%, by weight of the nutritional composition.
  • 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 composition.
  • the amount of any or all of the carbohydrates, fats, and proteins in any of the nutritional compositions (e.g ., infant formula) described herein may also be characterized as a percentage of total calories in the nutritional composition as set forth in the following table.
  • These macronutrients for nutritional compositions according to the present disclosure are most typically formulated within any of the caloric ranges (embodiments A-F) described in the following table (each numerical value is preceded by the term “about”).
  • the nutritional compositions according to the present disclosure may comprise one or more sources of fat.
  • Suitable sources of fat for use herein include any fat or fat source that is suitable for use in an oral nutritional composition and is compatible with the essential elements and features of such compositions.
  • the fat may be an emulsified fat suitable for infants, adults, or both infants and adults.
  • Suitable concentrations of fat may be in the range of from about 1% to about 30%, including from about 2% to about 15%, and also including from about 4% to about 10%, by weight.
  • the fat is derived from short-chain fatty acids.
  • suitable fats or sources thereof for use in the nutritional compositions described herein include coconut oil, fractionated coconut oil, soybean oil, com oil, olive oil, safflower oil, high oleic safflower oil, oleic acids (EMERSOL 6313 OLEIC ACID, Cognis Oleochemicals, Malaysia), MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm and palm kernel oils, palm olein, canola oil, marine oils, fish oils, fungal oils, algae oils, cottonseed oils, and combinations thereof.
  • Lipid sources of arachidonic acid (ARA) and docosahexaenoic acid (DHA) include, but are not limited to, marine oil, egg yolk oil, fungal oil, or algal oil.
  • soy and canola oils are available from Archer Daniels Midland of Decatur, Illinois. Corn, coconut, palm and palm kernel oils are available from Premier Edible Oils Corporation of Portland, Oregon. Fractionated coconut oil is available from Henkel Corporation of LaGrange, Illinois. High oleic safflower and high oleic sunflower oils are available from SVO Specialty Products of Eastlake, Ohio. Marine oil is available from Mochida International of Tokyo, Japan. Olive oil is available from Yale Oils of North Humberside, United Kingdom. Sunflower and cottonseed oils are available from Cargil of Minneapolis, Minnesota. Safflower oil is available from California Oils Corporation of Richmond, California.
  • structured lipids may be incorporated into the food product if desired.
  • Structured lipids are known in the art. A concise description of structured lipids can be found in INFORM, Vol. 8, No. 10, page 1004; entitled Structured lipids allow fat tailoring (October 1997). Also see U.S. Patent No. 4,871,768. Structured lipids are predominantly triacylglycerols containing mixtures of medium and long chain fatty acids on the same glycerol nucleus. Structured lipids and their use in enteral formula are also described in U.S. Patent No. 6,194,379 and U.S. Patent No. 6,160,007.
  • the nutritional compositions of the present disclosure may also include co-3 fatty acids, as part of the fat or oil included in the nutritional composition.
  • co-3 fatty acids include, but are not limited to, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
  • Dietary oils used in the preparation of the nutritional compositions generally contain co-3 fatty acids in the triglyceride form and include, but are not limited to, canola, fish, soybean, soy lecithin, corn, safflower, sunflower, high-oleic sunflower, high-oleic safflower, olive, borage, black currant, evening primrose, and flaxseed oil.
  • the nutritional compositions according to the present disclosure may include protein.
  • 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 composition.
  • Any protein source that is suitable for use in oral nutritional compositions and is compatible with the essential elements and features of such formulas is suitable for use in the nutritional compositions of the present disclosure.
  • Non-limiting examples of suitable proteins or sources thereof for use in the compositions of the present disclosure 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.
  • Non-limiting examples of such proteins include milk protein isolates, milk protein concentrates, casein protein isolates, extensively hydrolyzed casein, whey protein, sodium or calcium caseinates, whole cow milk, partially or completely defatted milk, soy protein isolates, and soy protein concentrates.
  • the nutritional compositions of the present disclosure include a protein source derived from milk proteins of human and/or bovine origin.
  • total protein content will vary depending on the target consumer, and depending on nutritional needs.
  • an infant formula is contemplated having up to about 21 grams of protein per liter.
  • an adult nutritional composition is contemplated having up to about 90 grams of protein per liter.
  • the protein source is a hydrolyzed protein, i.e., a protein hydrolysate.
  • hydrolyzed protein or “protein hydrolysates” are used interchangeably herein and include extensively hydrolyzed proteins, wherein the degree of hydrolysis is most often at least about 20%, including from about 20% to about 80%, and also including from about 30% to about 80%, even more preferably from about 40% to about 60%.
  • the degree of hydrolysis is the extent to which peptide bonds are broken by a hydrolysis method.
  • the degree of protein hydrolysis for purposes of characterizing the extensively hydrolyzed protein component of these embodiments is easily determined by one of ordinary skill in the formulation arts by quantifying the amino nitrogen to total nitrogen ratio (AN/TN) of the protein component of the selected formulation.
  • the amino nitrogen component is quantified by USP titration methods for determining amino nitrogen content, while the total nitrogen component is determined by the Tecator Kjeldahl method, all of which are well known methods to one of ordinary skill in the analytical chemistry art.
  • Suitable hydrolyzed proteins include casein protein hydrolysate, soy protein hydrolysate, whey protein hydrolysate, rice protein hydrolysate, potato protein hydrolysate, fish protein hydrolysate, egg albumen hydrolysate, gelatin protein hydrolysate, combinations of animal and vegetable protein hydrolysates, and combinations thereof.
  • Particularly preferred protein hydrolysates include casein protein hydrolysate, whey protein hydrolysate, and hydrolyzed sodium caseinate.
  • the protein source may include at least about 1% (by weight total protein) protein hydrolysate, including from about 2% to 100% (by weight total protein) protein hydrolysate, including from about 2% to 10% (by weight total protein) protein hydrolysate, including from about 5% to 100% (by weight total protein) protein hydrolysate, including from about 10% to 100% (by weight total protein) protein hydrolysate, and including from about 20% to about 80% (by weight total protein) protein hydrolysate, and including about 50% (by weight total protein) protein hydrolysate.
  • the nutritional composition includes 100% (by weight total protein) protein hydrolysate.
  • the nutritional compositions of the present disclosure may, in addition to the HMOs and any dietary fiber, include carbohydrates that are suitable for use in an oral nutritional composition and are compatible with the essential elements and features of such compositions. Where present, carbohydrate concentrations most typically will range from about 1% to about 40%, including from about 7% to about 30%, including from about 10% to about 25%, by weight of the nutritional composition.
  • Non-limiting examples of suitable carbohydrates or sources thereof for use in the nutritional compositions described herein include maltodextrin, hydrolyzed starch, modified starch, cornstarch, modified cornstarch, glucose polymers, com syrup, corn syrup solids, rice- derived carbohydrates, pea-derived carbohydrates, potato-derived carbohydrates, tapioca, sucrose, glucose, fructose, lactose, high fructose corn syrup, honey, and combinations thereof.
  • a particularly desirable carbohydrate is a low dextrose equivalent (DE) maltodextrin.
  • the nutritional compositions according to the present disclosure may further comprise other optional ingredients that may modify the physical, chemical, aesthetic, 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 medical food or other nutritional compositions or pharmaceutical dosage forms and may also be used in the nutritional compositions herein, provided that such optional ingredients are safe 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, emulsifying agents, buffers, antioxidants, pharmaceutical actives, anti-inflammatory agents, additional nutrients as described herein, colorants, flavors, thickening agents, and stabilizers, lubricants, and so forth.
  • the nutritional compositions of the present disclosure may comprise a sweetening agent, preferably including at least one sugar alcohol such as maltitol, erythritol, sorbitol, xylitol, mannitol, isomalt, and lactitol, and also preferably including at least one artificial or high potency sweetener such as acesulfame K, aspartame, sucralose, saccharin, stevia, and tagatose.
  • a sweetening agents especially as a combination of a sugar alcohol and an artificial sweetener, are especially useful in formulating liquid beverages having a desirable favor profile.
  • These sweetener combinations are especially effective in masking undesirable flavors sometimes associated with the addition of vegetable proteins to a liquid beverage.
  • Optional sugar alcohol concentrations in the nutritional composition may range 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.
  • Optional artificial sweetener concentrations may range from about 0.01%, including from about 0.05% to about 5%, also including from about 0.1% to about 1.0%, by weight of the nutritional composition.
  • a flowing agent or anti-caking agent may be included in the powdered form of the nutritional compositions as described herein to retard clumping or caking of the powder over time and to make a powder composition flow easily from its container.
  • Any known flowing or anti- caking agents that are known or otherwise suitable for use in a nutritional powder or product form are suitable for use herein, non-limiting examples of which include tricalcium phosphate, silicates, and combinations thereof.
  • the concentration of the flowing agent or anti-caking agent in the composition varies depending upon the product form, the other selected ingredients, the desired flow properties, and so forth, but most typically range from about 0.1% to about 4%, including from about 0.5% to about 2%, by weight of the nutritional composition.
  • a stabilizer may also be included in the nutritional compositions of the present disclosure. Any stabilizer that is known or otherwise suitable for use in a nutritional composition is also suitable for use herein, some non-limiting examples of which include gums such as xanthan gum.
  • the stabilizer may represent from about 0.1% to about 5.0%, including from about 0.5% to about 3%, including from about 0.7% to about 1.5%, by weight of the nutritional composition.
  • the nutritional compositions of the present disclosure may also comprise any of a variety of other vitamins or related nutrients, non-limiting examples of which include vitamin A, vitamin E, vitamin D, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B12, 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 E, vitamin D, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B12, niacin, folic acid, pantothenic acid, biotin, vitamin C, choline, inositol, salts and derivatives thereof, and combinations thereof.
  • compositions of the present disclosure include the following vitamins and minerals: calcium, phosphorus, sodium, chloride, magnesium, manganese, iron, copper, zinc, selenium, iodine, chromium, molybdenum, conditionally essential nutrients m- inositol, carnitine and taurine, and Vitamins A, C, D, E, K and the B complex, and mixtures thereof.
  • An antioxidant may also be included in the nutritional compositions of the present disclosure. Any antioxidant that is suitable for oral administration may be included for use in the nutritional compositions according to the present disclosure, including, for example, vitamin A, vitamin E, vitamin C, retinol, tocopherol, and carotenoids, including lutein, beta-carotene, zeaxanthin, and lycopene, and combinations thereof, for example.
  • the nutritional compositions of the present disclosure may also include one or more nucleotides and/or nucleosides.
  • Suitable nucleotides and/or nucleosides for use in the nutritional compositions of the present disclosure include one or more of cytidine 5 '-monophosphate, uridine 5 '-monophosphate, adenosine 5 '-monophosphate, guanosine 5 '-1 -monophosphate, and/or inosine 5 '-monophosphate, more preferably cytidine 5 '-monophosphate, uridine 5 '-monophosphate, adenosine 5 '-monophosphate, guanosine 5 '-monophosphate, and inosine 5 '-monophosphate.
  • the nutritional compositions according to the present disclosure may be prepared by any known or otherwise effective manufacturing technique for preparing such nutritional compositions. Many such techniques are known for any given product form such as nutritional liquids or nutritional powders and can easily be applied by one of ordinary skill in the art to the nutritional compositions described herein.
  • the nutritional compositions can therefore be prepared by any of a variety of known or otherwise effective formulation or manufacturing methods.
  • 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.
  • PIF protein-in-fat
  • CHO-MIN carbohydrate-mineral
  • PIW protein-in-water
  • the PIF slurry is formed by heating and mixing the oil (e.g., canola oil, corn oil, etc.) and then adding an emulsifier (e.g.
  • the CHO-MIN slurry is formed by adding with heated agitation to water: minerals (e.g, potassium citrate, dipotassium phosphate, sodium citrate, etc.), trace and ultra-trace minerals (TM/UTM premix), thickening or suspending agents (e.g, gellan gum, carrageenan).
  • minerals e.g, potassium citrate, dipotassium phosphate, sodium citrate, etc.
  • trace and ultra-trace minerals TM/UTM premix
  • thickening or suspending agents e.g, gellan gum, carrageenan
  • 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, etc.), and/or carbohydrates (e.g, HMOs, fructooligosaccharides, sucrose, com syrup, etc.).
  • additional minerals e.g, potassium chloride, magnesium carbonate, potassium iodide, etc.
  • carbohydrates e.g, HMOs, fructooligosaccharides, sucrose, com syrup, etc.
  • the resulting slurries are then blended together with agitation and the pH adjusted to 6.6-7.0, after which the composition is subjected to processing during which the composition is emulsified and homogenized.
  • 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.
  • This emulsion can then be further diluted, heat-treated, and packaged to form a ready-to-feed or concentrated liquid, or it can be heat-treated and subsequently processed and packaged as a reconstitutable powder, e.g, spray dried, dry mixed, agglomerated.
  • a probiotic blend comprising viable microorganisms may be provided in powder form separately (e.g, in a single serving packet) from the nutritional liquid and subsequently mixed with the nutritional liquid prior to consumption. If a probiotic blend comprising non-viable microorganisms is used, the probiotic blend may be added to one or more of the slurries described above.
  • the nutritional solid such as a spray dried nutritional powder or dry mixed nutritional powder, may be prepared by any collection of known or otherwise effective techniques, suitable for making and formulating a nutritional powder.
  • the spray drying step may likewise include any spray drying technique that is known for or otherwise suitable for use in the production of nutritional powders. Many different spray drying methods and techniques are known for use in the nutrition field, all of which are suitable for use in the manufacture of the spray dried nutritional powders herein.
  • One method of preparing the spray dried nutritional powder comprises forming and homogenizing an aqueous slurry or liquid comprising fat, and optionally protein, carbohydrate, and other sources of fat as described above, and then spray drying the slurry or liquid to produce a spray dried nutritional powder.
  • the method may further comprise the step of spray drying, dry mixing, or otherwise adding additional nutritional ingredients, including a probiotic blend or any one or more of the ingredients described herein, to form the spray dried nutritional powder.
  • Other suitable methods for making nutritional compositions are described, for example, in U.S. Pat. No. 6,365,218 (Borschel, etal.), U.S. Patent No. 6,589,576 (Borschel, etal.), U.S. Pat. No. 6,306,908 (Carlson, et al.), U.S. Patent Application No. 20030118703 A1 (Nguyen, et al. which descriptions are incorporated herein by reference to the extent that they are consistent herewith.
  • the methods of use according to the present disclosure include the oral administration of the nutritional compositions (e.g ., infant formulas, pediatric formulas, and adult formulas) that include a mixture of HMOs that includes a neutral HMO and an acidic HMO and a probiotic blend that includes Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus to treat gas in an individual, as well as to control, treat, and/or reduce symptoms and/or conditions associated with excessive gas production in an individual.
  • the nutritional compositions e.g ., infant formulas, pediatric formulas, and adult formulas
  • a mixture of HMOs that includes a neutral HMO and an acidic HMO
  • a probiotic blend that includes Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus
  • compositions as described herein can be administered to individuals including infants, toddlers, children, and adults generally, or may, in certain aspects of the present disclosure, be administered to a specific subclass of individuals that are “in need thereof;” that is, to specific infants that would particularly benefit from administration of the composition.
  • a specific infant may be “in need of’ the compositions as described herein if they are susceptible to, or suffering from, excessive gas production. This susceptibility may arise, for example, from one or more of a genetic predisposition or an underlying disease or condition that results in excessive gas production.
  • an adult individual may be in need of a composition according to the present disclosure for similar reasons.
  • Certain specific populations with need include those having substandard or abnormal maturation and/or development and/or function of the digestive system; individuals having symptoms associated with excessive gas production, such as bloating, fussiness, and abdominal cramping; and individuals who experience excessive flatulence (e.g ., expel intestinal gas more than 25 times per day).
  • the individual When administered to the individual in need thereof, the individual desirably consumes at least one serving of the nutritional composition daily, and in some embodiments, may consume two, three, or even more servings per day.
  • Each serving is desirably administered as a single, undivided dose, although the serving may also be divided into two or more partial or divided servings to be taken at two or more times during the day.
  • the methods according to the present disclosure include continuous day after day administration, as well as periodic or limited administration, although continuous day after day administration is generally desirable.
  • the methods according to the present disclosure are preferably applied on a daily basis, wherein the daily administration is maintained continuously for at least 3 days, including at least 5 days, including at least 1 month, including at least 6 weeks, including at least 8 weeks, including at least 2 months, including at least 6 months, desirably for at least about 18-24 months, desirably as a long-term, continuous, daily, dietary source or supplement.
  • the methods of use of the present disclosure include a method of treating fussiness due to gas in an infant by administering to the infant a nutritional composition comprising: a) a mixture of human milk oligosaccharides comprising a neutral human milk oligosaccharide and an acidic human milk oligosaccharide; and b) a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • the nutritional composition is effective for reducing intestinal gas production in the infant and thereby reduces fussiness caused by gas in the infant.
  • the methods of use of the present disclosure include a method of reducing odors associated with gas produced by an individual by administering to the individual a nutritional composition comprising: a) a mixture of human milk oligosaccharides comprising a neutral human milk oligosaccharide and an acidic human milk oligosaccharide; and b) a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus .
  • the gas produced by the individual after administration of the composition has a reduced amount of odor causing components as compared to gas produced by the individual after administration of an otherwise identical nutritional composition that does not include: i) a neutral human milk oligosaccharide; ii) an acidic human milk oligosaccharide; and iii) a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • the gas produced by the individual may contain at least 10% less, including at least 20% less, at least 30% less, at least 40% less, or at least 50% less odor causing components as compared to gas produced by the individual after administration of the otherwise identical nutritional composition that does not include components i), ii), and iii).
  • the odor causing components include, but are not limited to, sulfur or sulfur containing compounds (e.g ., hydrogen sulfide), short-chain fatty acids (e.g., acetate, propionate, butyrate), and combinations thereof.
  • a nutritional composition comprising a mixture of HMOs including a fucosylated and a sialylated HMO and a probiotic blend including Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus , alone or in combination with another HMO (e.g., LNT, LNnT) is administered to an individual.
  • the nutritional composition reduces intestinal gas production and/or symptoms associated with excessive gas production, including fussiness associated with gas production in an infant, and/or reduces odors associated with gas produced by an individual.
  • Example 1 Previous studies have established that microbial cultures can be obtained from human fecal samples and maintained in the laboratory for experimental evaluation of microbial gas production and composition.
  • a fresh fecal sample was obtained from six (6) healthy adults aged 35 to 65 with no antibiotic use in the preceding six (6) months and who did not follow a vegetarian or vegan diet.
  • fecal samples were placed in a container with an agent to remove oxygen and were stored in a refrigerated environment.
  • the fecal samples were anaerobically processed and aliquoted (5 mL) within 16 hours after defecation.
  • the aliquots were stored at -20 °C.
  • the frozen fecal samples were used within 3 months and each 5 mL aliquot was used only once.
  • Viable fecal microbial samples including 0.25 mL of a low-nutrient bacterial culture media containing 0.1% (v/v) (or 0.25 pL) of fecal sample were cultured in microwell plates under conditions that mimic the human colon for twenty (20) hours.
  • the dose of 2’-FL used in Treatments A and B provided a final concentration of 1.2 g/L (or about 0.3 mg of 2’-FL per 0.25 mL culture sample).
  • the dose of probiotic blend used in Treatments B, D, and E provided a final concentration of 0.5 g/L or 1.25 x 10 9 CFU/L (or about 0.125 mg of probiotic blend per 0.25 mL culture sample, or about 3.1 x 10 5 CFU per 0.25 mL culture sample).
  • the dose of the blend of HMOs used in Treatments C and D provided a final concentration of 1.2 g/L (or 0.3 mg of the blend of HMOs per 0.25 mL culture sample).
  • the concentration of carbon dioxide (CO2) was measured at twenty (20) hours after the addition of the treatment component(s).
  • the measurement involved direct mass spectrometric (MS) quantification of gases after sampling.
  • the change in CO2 production over the 20 hour period of time was analyzed for each of the six donors relative to CO2 production in untreated (i.e., no added treatment components) fecal samples from the same donor and was expressed as a percentage change.
  • the data shown in FIG. 1 and in Table 1 below represents the mean change in CO2 production across all six donors for each treatment.
  • Carbon dioxide concentration and/or production can provide an indication (e.g ., serve as a marker) of microbiome function.
  • the data shown in FIG. 1 and Table 1 demonstrate that Treatment B (2’-FL and probiotic blend) and Treatment D (blend of HMOs and probiotic blend) reduce CO2 production by an in vitro microbiome model. Because CO2 is a prevalent gas produced by the microbiome, reducing CO2 production results in the effective treatment of gas and symptoms associated with excessive gas production such as, for example, bloating, fussiness, abdominal cramping, and general gastrointestinal discomfort.
  • Example 2 The following is an exemplary powdered nutritional composition (infant formula) according to the present disclosure.
  • Example 3 The following is an exemplary powdered nutritional composition (infant formula) according to the present disclosure.
  • Example 4 The following is an exemplary powdered nutritional composition (infant formula) according to the present disclosure.
  • a nutritional composition for use in treating gas in an individual comprising: a) a mixture of human milk oligosaccharides comprising a neutral human milk oligosaccharide and an acidic human milk oligosaccharide; and b) a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus .
  • the neutral human milk oligosaccharide comprises at least one of 2’-fucosyllactose, 3-fucosyllactose, and combinations thereof.
  • the nutritional composition for use according to clause 5, wherein the nutritional composition is a powder comprising 1 wt% to 10 wt%, based on the total weight of the nutritional composition, of a combination of 2’-fucosyllactose, 3-fucosyllactose, 3’-sialyllactose, 6’- sialyllactose, and lacto-N-tetraose.
  • the nutritional composition is a powder comprising 1 wt% to 10 wt%, based on the total weight of the nutritional composition, of a combination of 2’-fucosyllactose, 3-fucosyllactose, 3’-sialyllactose, 6’- sialyllactose, and lacto-N-tetraose.
  • CFU colony forming units
  • the nutritional composition for use according to any one of clauses 1 to 9, wherein the nutritional composition further comprises a dietary fiber comprising at least one of fructooligosaccharides, galactooligosaccharides, inulin, polydextrose, 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 methoxy pectin, high methoxy pectin, cereal beta-glucans, carrageenan, psyllium, digestion resistant maltodextrin, or combinations thereof.
  • a dietary fiber comprising at least one of fructooligosaccharides, galactooligosaccharides, inulin, polydextrose
  • hydrolyzed protein comprises at least one of casein protein hydrolysate, soy protein hydrolysate, whey protein hydrolysate, rice protein hydrolysate, potato protein hydrolysate, fish protein hydrolysate, egg albumen hydrolysate, gelatin protein hydrolysate, or combinations thereof.
  • a nutritional composition for use in treating fussiness due to gas in an infant comprising: a) a mixture of human milk oligosaccharides comprising a neutral human milk oligosaccharide and an acidic human milk oligosaccharide; and b) a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • the nutritional composition for use according to clause 15, wherein the nutritional composition further comprises lacto-N-tetraose, the neutral human milk oligosaccharide comprises 2’-fucosyllactose and 3-fucosyllactose, and the acidic human milk oligosaccharide comprises 3’- sialyllactose and 6’-sialyllactose.
  • CFU colony forming units
  • a dietary fiber comprising at least one of fructooligosaccharides, galactooligosaccharides, inulin, polydextrose,
  • hydrolyzed protein comprises at least one of casein protein hydrolysate, soy protein hydrolysate, whey protein hydrolysate, rice protein hydrolysate, potato protein hydrolysate, fish protein hydrolysate, egg albumen hydrolysate, gelatin protein hydrolysate, or combinations thereof.
  • a nutritional composition for use in reducing odors associated with gas produced by an individual comprising: a) a mixture of human milk oligosaccharides comprising a neutral human milk oligosaccharide and an acidic human milk oligosaccharide; and b) a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • a nutritional composition for the manufacture of a medicament for treating gas in an individual comprising: a) a mixture of human milk oligosaccharides comprising a neutral human milk oligosaccharide and an acidic human milk oligosaccharide; and b) a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.
  • the nutritional composition further comprises lacto-N-tetraose
  • the neutral human milk oligosaccharide comprises 2’-fucosyllactose and 3- fucosyllactose
  • the acidic human milk oligosaccharide comprises 3’-sialyllactose and 6’- sialyllactose.
  • the nutritional composition is a liquid comprising 0.001 g/L to 20 g/L of a combination of 2’-fucosyllactose, 3-fucosyllactose, 3’- sialyllactose, 6’-sialyllactose, and lacto-N-tetraose.
  • the nutritional composition is a liquid comprising 0.001 g/L to 20 g/L of a combination of 2’-fucosyllactose, 3-fucosyllactose, 3’- sialyllactose, 6’-sialyllactose, and lacto-N-tetraose.
  • the nutritional composition is a liquid comprising 2’-fucosyllactose in an amount up to 4.15 g/L, lacto-N-tetraose in an amount up to 2.11 g/L, 3-fucosyllactose in an amount up to 1.17 g/L, 3’-sialyllactose in an amount up to 0.36 g/L, and 6’-sialyllactose in an amount up to 0.44 g/L.
  • the nutritional composition is a powder comprising 1 wt% to 10 wt%, based on the total weight of the nutritional composition, of a combination of 2’-fucosyllactose, 3-fucosyllactose, 3’-sialyllactose, 6’-sialyllactose, and lacto-N- tetraose.
  • CFU colony forming units
  • the nutritional composition further comprises a dietary fiber comprising at least one of fructooligosaccharides, galactooligosaccharides, inulin, polydextrose, oat fiber, soy fiber, gum arabic, sodium carboxymethyl cellulose, 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 methoxy pectin, high methoxy pectin, cereal beta-glucans, carrageenan, psyllium, digestion resistant maltodextrin, or combinations thereof.
  • a dietary fiber comprising at least one of fructooligosaccharides, galactooligosaccharides, inulin, polydextrose, oat fiber, soy fiber, gum arabic, sodium carb
  • hydrolyzed protein comprises at least one of casein protein hydrolysate, soy protein hydrolysate, whey protein hydrolysate, rice protein hydrolysate, potato protein hydrolysate, fish protein hydrolysate, egg albumen hydrolysate, gelatin protein hydrolysate, or combinations thereof.
  • the nutritional composition further comprises lacto-N-tetraose
  • the neutral human milk oligosaccharide comprises 2’-fucosyllactose and 3- fucosyllactose
  • the acidic human milk oligosaccharide comprises 3’-sialyllactose and 6’- sialyllactose.
  • the nutritional composition is a liquid comprising 0.001 g/L to 20 g/L of a combination of 2’-fucosyllactose, 3-fucosyllactose, 3’- sialyllactose, 6’-sialyllactose, and lacto-N-tetraose.
  • the nutritional composition is a liquid comprising 2’-fucosyllactose in an amount up to 4.15 g/L, lacto-N-tetraose in an amount up to 2.11 g/L, 3-fucosyllactose in an amount up to 1.17 g/L, 3’-sialyllactose in an amount up to 0.36 g/L, and 6’-sialyllactose in an amount up to 0.44 g/L.
  • the nutritional composition is a powder comprising 1 wt% to 10 wt%, based on the total weight of the nutritional composition, of a combination of 2’-fucosyllactose, 3-fucosyllactose, 3’-sialyllactose, 6’-sialyllactose, and lacto-N- tetraose.
  • CFU colony forming units
  • the nutritional composition further comprises a dietary fiber comprising at least one of fructooligosaccharides, galactooligosaccharides, inulin, polydextrose, oat fiber, soy fiber, gum arabic, sodium carboxymethyl cellulose, 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 methoxy pectin, high methoxy pectin, cereal beta-glucans, carrageenan, psyllium, digestion resistant maltodextrin, or combinations thereof.
  • a dietary fiber comprising at least one of fructooligosaccharides, galactooligosaccharides, inulin, polydextrose, oat fiber, soy fiber, gum arabic, sodium carb
  • hydrolyzed protein comprises at least one of casein protein hydrolysate, soy protein hydrolysate, whey protein hydrolysate, rice protein hydrolysate, potato protein hydrolysate, fish protein hydrolysate, egg albumen hydrolysate, gelatin protein hydrolysate, or combinations thereof.
  • [00182] 54 Use of a nutritional composition for the manufacture of a medicament for reducing odors associated with gas produced by an individual, the nutritional composition comprising: a) a mixture of human milk oligosaccharides comprising a neutral human milk oligosaccharide and an acidic human milk oligosaccharide; and b) a probiotic blend comprising Bifidobacterium lactis , Bifidobacterium infantis , and Streptococcus thermophilus.

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Abstract

L'invention concerne des procédés et des compositions nutritionnelles pour le traitement des gaz chez un individu. Les compositions nutritionnelles sont utiles pour le traitement des gaz chez un individu et comprennent un mélange d'oligosaccharides du lait humain et d'un mélange probiotique de Bifidobacterium lactis, de Bifidobacterium infantis et de Streptococcus thermophilus.
PCT/US2022/033376 2021-06-14 2022-06-14 Procédés et compositions pour le traitement des gaz WO2022266058A1 (fr)

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