# US 11,439,616 B2 · Compositions and methods of treating and reducing risk of conditions associated with elevated 4-ethylphenyl sulfate > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,439,616 B2 - Document ID: US11439616B2 - Status: Granted - Kind: B2 - Application number: 16/721,466 - Filed: 2019-12-19 - Published: 2021-06-24 - Granted: 2022-09-13 - Earliest claimed: 2019-12-19 - Assignees: Hill's Pet Nutrition, Inc. - Applicants: Hill's Pet Nutrition, Inc. - Inventors: Eden Ephraim; Dennis Jewell - Web page: https://patentgrep.com/patent/US11439616B2 ## CPC - A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557) - 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 31/355: Tocopherols, e.g. vitamin E - A61K 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof - A61K 47/02: Inorganic compounds - A61K 47/12: Carboxylic acids; Salts or anhydrides thereof - A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters - A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin - A61K 47/38: Cellulose; Derivatives thereof - A61K 47/42: Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein (oligopeptides having up to five amino acids {A61K47/183}; polyamino acids A61K47/34) - A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14) - A61K 47/46: Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts - A61P 25/22: Anxiolytics - 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) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract Compositions and methods of treating anxiety or stress in an animal are disclosed. Compositions and methods of reducing or preventing elevated levels of 4-EPS are disclosed. Compositions and methods for promoting growth of beneficial microbes in an animal's microbiome and inhibiting growth of non-beneficial microbes are disclosed. The methods comprise administering to the animal an effective amount of n-3 fatty acids, antioxidants, insoluble fiber and soluble fiber in an effective ratio of insoluble fiber and soluble fiber. Compositions comprise effective amounts of n-3 fatty acids, antioxidants, insoluble fiber and soluble fiber in an effective ratio of insoluble fiber and soluble fiber. ## Claims ### Claim 1 A method for reducing levels of 4-ethylphenyl sulfate in an animal comprising: administering to the animal in need thereof an effective amount of a food composition comprising: n-3 fatty acids, antioxidants, Vitamin C, Vitamin E, insoluble fiber, and soluble fiber, wherein the insoluble fiber and the soluble fiber are present in a ratio of from 2.0 to 3.0, wherein the Vitamin C is present in an amount greater than 400 ppm, wherein the Vitamin E is present in an amount greater than 1000 IU/kg, wherein the n-3 fatty acids are present in an amount of from 0.6% to 0.9%, wherein the administering of the food composition treats anxiety or stress in the animal. ### Claim 2 (depends on 1) The method of claim 1 wherein the animal is administered n-3 fatty acids equal to 0.65-0.85% of nutritional intake per day. ### Claim 3 (depends on 1) The method of claim 1 wherein the animal is administered n-3 fatty acids equal to 0.70-0.75% of nutritional intake per day. ### Claim 4 (depends on 1) The method of claim 1 wherein the animal is administered n-3 fatty acids equal to 0.72-0.79% of nutritional intake per day. ### Claim 5 (depends on 1) The method of claim 1 wherein the animal is administered Vitamin C equal to 450 ppm of nutritional intake per day. ### Claim 6 (depends on 1) The method of claim 1 wherein the animal is administered Vitamin C equal to 475 ppm of nutritional intake per day. ### Claim 7 (depends on 1) The method of claim 1 wherein the animal is administered Vitamin C equal to 490 ppm of nutritional intake per day. ### Claim 8 (depends on 1) The method of claim 1 wherein the animal is administered Vitamin E equal to 1100 IU/kg of nutritional intake per day. ### Claim 9 (depends on 1) The method of claim 1 wherein the animal is administered Vitamin E equal to 1200 IU/kg of nutritional intake per day. ### Claim 10 (depends on 1) The method of claim 1 wherein the animal is administered Vitamin E equal to 1400 IU/kg of nutritional intake per day. ### Claim 11 (depends on 1) The method of claim 1, wherein the ratio of the insoluble fiber to the soluble fiber is from 2.2 to 2.7. ### Claim 12 (depends on 1) The method of claim 1, wherein the ratio of the insoluble fiber to the soluble fiber is from 2.3 to 2.6. ### Claim 13 (depends on 1) The method of claim 1, wherein the ratio of the insoluble fiber to the soluble fiber is from 2.4 to 2.5. ### Claim 14 (depends on 1) The method of claim 1 wherein the animal is administered insoluble fiber and soluble fiber an amount equal to 4.0-5.5% of nutritional intake per day. ### Claim 15 (depends on 1) The method of claim 1 wherein the animal is administered insoluble fiber and soluble fiber an amount equal to 4.5-5.0% of nutritional intake per day. ### Claim 16 (depends on 1) The method of claim 1 wherein the animal is administered insoluble fiber and soluble fiber an amount equal to 4.7-4.9% of nutritional intake per day. ### Claim 17 (depends on 1) The method of claim 1 wherein the animal is a canine. ### Claim 18 (depends on 17) The method of claim 17 wherein the canine is identified as having an elevated level of 4-ethylphenyl sulfate. ### Claim 19 (depends on 17) The method of claim 17 wherein the canine has previously been identified as having canine anxiety. ### Claim 20 (depends on 17) The method of claim 17 wherein the canine has previously been identified as having canine stress symptoms. ### Claim 21 A food composition comprising an effective amount of n-3 fatty acids, vitamin C, vitamin E, insoluble fiber and soluble fiber to treat anxiety, stress or a stress disorder in an animal, wherein the effective amount of n-3 fatty acids equal to 0.6-0.9% of nutritional intake per day, vitamin C at a level of 400 ppm or more of nutritional intake per day, vitamin E at a level of 1000 IUK of nutritional intake per day and insoluble fiber and soluble fiber in a ratio of insoluble fiber/soluble fiber of between 2.0 and 3.0. ### Claim 22 (depends on 21) The food composition of claim 21, wherein the effective amount of n-3 fatty acids equal to 0.65-0.85% of nutritional intake per day, vitamin C at a level of 450 ppm or more of nutritional intake per day, vitamin E at a level of 1100 IUK of nutritional intake per day and insoluble fiber and soluble fiber in a ratio of insoluble fiber/soluble fiber of between 2.2 and 2.8. ### Claim 23 (depends on 21) The food composition of claim 21, wherein the effective amount of n-3 fatty acids equal to 0.70-0.80% of nutritional intake per day, vitamin C at a level of 475 ppm or more of nutritional intake per day, vitamin E at a level of 1200 IUK of nutritional intake per day and insoluble fiber and soluble fiber in a ratio of insoluble fiber/soluble fiber of between 2.3 and 2.7. ### Claim 24 (depends on 21) The food composition of claim 21, wherein the effective amount of n-3 fatty acids equal to 0.72-0.79% of nutritional intake per day, vitamin C at a level of 490 ppm or more of nutritional intake per day, vitamin E at a level of 1400 IUK of nutritional intake per day and insoluble fiber and soluble fiber in a ratio of insoluble fiber/soluble fiber of between 2.4 and 2.5. ### Claim 25 (depends on 21) The food composition of claim 21 wherein the amount of insoluble fiber and soluble fiber is equal to 4.0-5.5% of nutritional intake per day. ### Claim 26 (depends on 21) The food composition of claim 21 wherein the amount of insoluble fiber and soluble fiber is equal to 4.5-5.0% of nutritional intake per day. ### Claim 27 (depends on 21) The food composition of claim 21 wherein the amount of insoluble fiber and soluble fiber is equal to 4.7-4.9% of nutritional intake per day. ### Claim 28 (depends on 21) The food composition of claim 21, wherein the food composition is a canine food composition. ### Claim 29 (depends on 1) The method of claim 1, further comprising identifying the animal in need thereof as having an elevated level of 4-ethylphenyl sulfate, wherein the animal in need thereof is a canine.