# US 10,441,602 B2 · Human gastrointestinal microbiome modulating composition and methods of use

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- Number: US 10,441,602 B2
- Document ID: US10441602B2
- Status: Granted
- Kind: B2
- Application number: 15/288,533
- Filed: 2016-10-07
- Published: 2017-03-23
- Granted: 2019-10-15
- Earliest claimed: 2011-08-17
- Assignees: MicroBiome Therapeutics, LLC
- Applicants: Microbiome Therapeutics LLC
- Inventors: Mark L. Heiman; Dean P. Stull; Justin W. Peno
- Web page: https://patentgrep.com/patent/US10441602B2

## CPC

- A61K 31/733: Fructosans, e.g. inulin
- A23L 29/212: Starch; Modified starch; Starch derivatives, e.g. esters or ethers (containing starch hydrolysates, e.g. dextrin, A23L29/30)
- A23L 33/00: Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L 33/105: Plant extracts, their artificial duplicates or their derivatives
- A23L 33/21: Addition of substantially indigestible substances, e.g. dietary fibres
- A23L 33/30: {Dietetic or nutritional methods, e.g. for losing weight (A23L33/10 takes precedence)}
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 31/047: having two or more hydroxy groups, e.g. sorbitol
- A61K 31/155: Amidines ([IMAGE cpc-sch-A61K-1029.gif]), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
- A61K 31/716: Glucans
- A61K 31/718: Starch or degraded starch, e.g. amylose, amylopectin
- A61K 36/00: Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines {(antigens from pollen A61K39/36)}
- A61K 36/45: Ericaceae or Vacciniaceae (Heath or Blueberry family), e.g. blueberry, cranberry or bilberry
- A61K 36/88: Liliopsida (monocotyledons)
- A61K 36/899: Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
- A61K 38/28: Insulins
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/12: Antidiarrhoeals
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A61K 9/0031: {Rectum, anus}
- A61K 9/10: Dispersions; Emulsions
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

A formulation to increase the ratio of gastrointestinal microbiota in phylum Bacteroidetes to microbiota of Firmicutes phylum preferably includes about 20-60 mg/kg of body weight of fermentable fiber, about 10-30 mg/kg of body weight of beta glucan and about 20-60 mg/kg of body weight of blueberry extracts or any fruit or berry ingredient preparation containing similar phenolics. This formulation is preferably used to control body weight, body composition, and blood glucose regulation, preferably in humans, and is preferably administered orally, preferably twice per day.

## Claims

### Claim 1

A human gastrointestinal microbiome modulating composition for improving blood glucose regulation in a human in need thereof which has fewer than 200 usable Calories per therapeutic dose, comprising:
a) at least about 3 g of isolated inulin,
b) at least about 2 g of a purified β-glucan, and
c) a berry pomace or a berry pomace extract;
wherein each therapeutic dose comprises about 2-120 mg/kg of body weight of the berry pomace or the berry pomace extract.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the composition comprises fewer than 70 usable Calories per therapeutic dose.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the composition is formulated as a beverage suspension, powder, bar, smoothie, yogurt, shake, capsule, or tablet.

### Claim 4 (depends on 1)

The composition according to claim 1, wherein the berry pomace or the berry pomace extract is from a berry selected from the group consisting of blueberry, cranberry, raspberry, and strawberry.

### Claim 5 (depends on 4)

The composition according to claim 4, wherein the berry pomace or the berry pomace extract is from blueberry.

### Claim 6 (depends on 1)

The composition according to claim 1, wherein the berry pomace or the berry pomace extract comprises polyphenol compounds.

### Claim 7 (depends on 6)

The composition according to claim 6, wherein the polyphenol compounds are selected from the group consisting of anthocyanidins, flavonoids, cyanidin, delphinidin, malvidin, petunidin, anthocyanin, epicatechin, catechin, myricetin, quercetin, peonidin, epigallocatechin gallate, epigallocatechin, epicatechin gallate, epicatechin, gallocatechin gallate, gallocatechin, catechin gallate, malvidin 3-O-Galactoside, malvidin 3-O-Arabinoside, malvidin 3-O-Glucoside, delphinidin 3-O-Arabinoside, delphinidin 3-O-Galactoside, Delphinidin 3-O-Glucoside, petunidin 3-O-Galactoside, petunidin 3-O-Arabinoside, petunidin 3-O-Glucoside, peonidin chloride, cyanidin 3-O-Arabinoside, peonidin 3-O-Glucoside, cyanidin 3-O-Glucoside, delphinidin Chloride, peonidin 3-O-Arabinoside, peonidin 3-O-Galactoside, petunidin chloride, cyanidin chloride, cyanidin 3-O-Galactoside, cyanidin 3-O-Rutinoside, malvidin chloride, and combinations thereof.

### Claim 8 (depends on 7)

The composition according to claim 7, wherein the polyphenol compounds comprise anthocyanidins.

### Claim 9 (depends on 7)

The composition according to claim 7, wherein the polyphenol compounds comprise flavonoids.

### Claim 10 (depends on 1)

The composition according to claim 1, wherein the inulin is present in an amount of 4-40% by weight.

### Claim 11 (depends on 1)

The composition according to claim 1, wherein the β-glucan is present in an amount of 3.5-14% by weight.

### Claim 12 (depends on 6)

The composition according to claim 6, wherein the polyphenol compounds are present in an amount of 1-6% by weight.

### Claim 13 (depends on 1)

The composition of claim 1, wherein the composition comprises fewer than 100 usable Calories per dose.

### Claim 14 (depends on 1)

The composition of claim 1, wherein the composition comprises fewer than 150 usable Calories per therapeutic dose.

### Claim 15 (depends on 1)

A method of improving blood glucose regulation in a human in need thereof, the method comprising administering to the human in need the composition according to claim 1.

### Claim 16 (depends on 15)

The method according to claim 15, wherein the composition is administered to the human in need at least once per day.

### Claim 17 (depends on 15)

The method according to claim 15, wherein the human in need is a diabetic.

### Claim 18 (depends on 15)

The method according to claim 15, wherein the human in need has Type I diabetes.

### Claim 19 (depends on 15)

The method according to claim 15, wherein the human in need has Type II diabetes.