# US 11,026,913 B2 · Nutritional formulas comprising medium chain fatty acids or esters thereof and methods related thereto

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- Number: US 11,026,913 B2
- Document ID: US11026913B2
- Status: Granted
- Kind: B2
- Application number: 14/916,634
- Filed: 2014-09-04
- Published: 2016-07-14
- Granted: 2021-06-08
- Earliest claimed: 2013-09-05
- Assignees: Emory University; Children's Healthcare of Atlanta, Inc.
- Applicants: Emory University; Children's Healthcare of Atlanta, Inc.
- Inventors: Claudia R. Morris
- Web page: https://patentgrep.com/patent/US11026913B2

## CPC

- A61K 31/23: of acids having a carboxyl group bound to a chain of seven or more carbon atoms
- A23L 33/12: Fatty acids or derivatives thereof
- A23L 33/135: Bacteria or derivatives thereof, e.g. probiotics
- A23L 33/15: Vitamins
- A23L 33/155: Vitamins A or D
- A23L 33/16: Inorganic salts, minerals or trace elements
- A23L 33/175: Amino acids
- A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula}
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 31/047: having two or more hydroxy groups, e.g. sorbitol
- A61K 31/07: Retinol compounds, e.g. vitamin A (retinoic acids A61K31/203)
- A61K 31/122: having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61K 31/20: having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557)
- A61K 31/205: Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
- A61K 31/22: of acyclic acids, e.g. pravastatin
- A61K 31/231: having one or two double bonds
- A61K 31/232: having three or more double bonds, e.g. etretinate
- A61K 31/355: Tocopherols, e.g. vitamin E
- A61K 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof
- A61K 31/385: having two or more sulfur atoms in the same ring
- A61K 31/4375: the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
- A61K 31/473: ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
- A61K 31/59: Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K 31/661: Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion {or mevinphos}
- A61K 31/7004: Monosaccharides having only carbon, hydrogen and oxygen atoms
- A61K 33/18: Iodine; Compounds thereof
- A61K 33/24: Heavy metals; Compounds thereof
- A61K 33/26: Iron; Compounds thereof
- A61K 33/30: Zinc; Compounds thereof
- A61K 33/32: Manganese; Compounds thereof
- A61K 33/34: Copper; Compounds thereof
- A61K 33/42: Phosphorus; Compounds thereof
- A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06)
- A61K 38/46: Hydrolases (3)
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A61K 9/145: {with organic compounds}
- A61K 9/2013: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/4858: {Organic compounds}
- A61K 2035/115: {Probiotics}
- 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)
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

This disclosure relates to nutritional formulas and uses for treating or preventing a gastrointestinal condition and/or motor-planning speech and/or coordinator difficulties. In certain embodiments, this disclosure relates to a nutritional formula comprising medium 5 chain fatty acids, or esters thereof (such as and tri-, di-, mono-glycerides, or alkyl esters), unsaturated fatty acids, and a vitamin E and optionally other nutrients. In certain embodiments, any of the compounds or nutrients may be in alternative salt forms.

## Claims

### Claim 1

A method of treating autism spectrum disorder comprising orally administering daily to a subject diagnosed with an autism spectrum disorder, apraxia, and a gastrointestinal tract impairment, an effective amount of a dietary formulation comprising:
a) a medium chain fatty acid, glycerol ester, or alkyl ester thereof,
b) an omega-3 fatty acid, glycerol ester, or alkyl ester thereof,
c) an omega-6 fatty acid, glycerol ester, or alkyl ester thereof, and
d) a vitamin E isomer from 100 mg to 10,000 mg,
e) 5-hydroxytryptophan, from 10 mg to 100 mg,
f) sulforaphane from 500 micrograms to 5000 micrograms, and
g) curcumin from 50 mg to 2500 mg; and
wherein the dietary formulation comprises less than 2% long chain saturated fatty acids by weight of the total weight of fatty acids.

### Claim 2 (depends on 1)

The method of claim 1, wherein the gastrointestinal tract impairment is intestinal lymphangiectasia.

### Claim 3 (depends on 1)

The method of claim 1, wherein the gastrointestinal tract impairment is maldigestion.

### Claim 4 (depends on 1)

The method of claim 1, wherein the gastrointestinal tract impairment is malabsorption.

### Claim 5 (depends on 1)

The method of claim 1, wherein the gastrointestinal tract impairment is small intestinal bacterial overgrowth.

### Claim 6 (depends on 1)

The method of claim 1, wherein the subject is a sub-adult from 12 months to 19 years of age.

### Claim 7 (depends on 6)

The method of claim 6, wherein the sub-adult is from about 12 months of age to about 3 years of age.

### Claim 8 (depends on 6)

The method of claim 6, wherein the sub-adult is from 3 years of age to 5 years of age.

### Claim 9 (depends on 6)

The method of claim 6, wherein the sub-adult is 5 years of age to 9 years of age.

### Claim 10 (depends on 6)

The method of claim 6, wherein the sub-adult is 9 years of age to 12 years of age.

### Claim 11 (depends on 6)

The method of claim 6, wherein the sub-adult is 13 years of age to 19 years of age.

### Claim 12 (depends on 1)

The method of claim 1, wherein the medium chain fatty acid or alkyl ester thereof is capric acid, ethyl caprate, caprylic acid, ethyl caprylate, hexanoic acid, ethyl hexanoate, or combinations thereof.

### Claim 13 (depends on 1)

The method of claim 1, wherein the dietary formulation further comprises a vitamin K.

### Claim 14 (depends on 1)

The method of claim 1, wherein the omega-3 fatty acid or alkyl ester thereof is alpha-linolenic acid, eicosapentaenoic acid, docosahexaenoic acid, ethyl linolenate, ethyl eicosapentaenoate, ethyl docosahexaenoate, or combinations thereof.

### Claim 15 (depends on 1)

The method of claim 1, wherein the omega-3 fatty acid contains eicosapentaenoic acid and docosahexaenoic acid.

### Claim 16 (depends on 15)

The method of claim 15, wherein a ratio of eicosapentaenoic acid and docosahexaenoic acid is in a range of from about 1.5:1 to about 5:1.

### Claim 17 (depends on 1)

The method of claim 1, wherein the vitamin E isomer is alpha-tocopherol, gamma-tocopherol, or a combination thereof.

### Claim 18 (depends on 1)

The method of claim 1, wherein the omega-6 fatty acid is gamma-linolenic acid.

### Claim 19 (depends on 1)

The method of claim 1, wherein the dietary formulation comprises less than 1% long chain saturated fatty acids by weight of the total weight of fatty acids.