# US 9,433,599 B2 · Methods and lipid compositions for promoting development of gut flora > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,433,599 B2 - Document ID: US9433599B2 - Status: Granted - Kind: B2 - Application number: 13/643,513 - Filed: 2011-04-26 - Published: 2013-02-14 - Granted: 2016-09-06 - Earliest claimed: 2010-04-26 - Assignees: Enzymotec Ltd. - Applicants: Fabiana Bar-Yoseph; Yonatan Manor; Tzafra Cohen; Amit Goren; Yael Lifshitz - Inventors: Fabiana Bar-Yoseph; Yonatan Manor; Tzafra Cohen; Amit Goren; Yael Lifshitz - Web page: https://patentgrep.com/patent/US9433599B2 ## CPC - A61K 31/23: of acids having a carboxyl group bound to a chain of seven or more carbon atoms - A23L 33/115: Fatty acids or derivatives thereof; Fats or oils - A23L 33/125: containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates (indigestible substances A23L33/21) - A23L 33/15: Vitamins - A23L 33/16: Inorganic salts, minerals or trace elements - A23L 33/17: Amino acids, peptides or proteins - A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula} - 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 17/04: Antipruritics - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics - A61P 31/04: Antibacterial agents - A61P 37/04: Immunostimulants - A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14) - A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs - 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 Disclosed is a method of inducing and promoting development of beneficial gut flora in a subject and/or of reducing the frequency and duration of crying periods in a subject, the method comprises administering to the subject a lipid composition comprising a vegetable-derived fat source, wherein the fat source is a triglyceride fat source comprising triglycerides with 15-55% palmitic acid moieties out of the total fatty acids, and wherein the level of palmitic acid moieties at the sn-2 position of the glycerol backbone is at least 30% of total palmitic acid. The method is particularly intended for children. Specific fat sources, as well as food articles and a commercial package comprising the same are disclosed. ## Claims ### Claim 1 A method of promoting development of beneficial gut flora in an infant consisting essentially of administering to said infant a lipid composition consisting essentially of an enzymatically prepared, vegetable-derived fat source consisting essentially of triglycerides, wherein said triglycerides consist essentially of fatty acid moieties with 15-55% of said fatty acid moieties being palmitic acid moieties; wherein at least 30% of said palmitic acid moieties are at the sn-2 position of the triglyceride backbone; wherein at least 50% of the total fatty acid moieties at the sn-1 and sn-3 positions of the triglyceride backbone are unsaturated; and wherein at least 35% of said unsaturated fatty acid moieties at the sn-1 and sn-3 positions are oleic acid moieties and at least 4% of said unsaturated fatty acid moieties at the sn-1 and sn-3 positions are linoleic acid moieties; wherein administration of the lipid composition has an effect on the immune system of the infant and the infant suffers from at least one disorder of the immune system resulting from gut flora imbalance, and is diagnosed with having an imbalance in the profile of the gut flora population compared to the gut flora profile of breastfed infants. so as to thereby promote development of beneficial gut flora in the infant. ### Claim 2 (depends on 1) The method of claim 1, wherein at least one pathogenic bacteria is present in the gut of the infant, wherein the lipid composition has an effect on colonization of said at least one pathogenic bacteria in the gut of the infant, and wherein the effect is selected from the group consisting of inhibiting, preventing and reducing colonization of the at least one pathogenic bacteria. ### Claim 3 (depends on 1) The method of claim 1, wherein said at least one disorder of the immune system is selected from the group consisting of inflammation, atopy, allergy, feeding intolerance and infection, and the lipid composition is effective to treat such disorder. ### Claim 4 (depends on 1) The method of claim 1, wherein the lipid composition promotes development of gut flora enhanced with bifidobacteria and lactobacilli. ### Claim 5 (depends on 2) The method of claim 2, wherein the lipid composition inhibits colonization of said at least one pathogenic bacteria in the gut of the infant. ### Claim 6 (depends on 1) The method of claim 1, wherein said infant was delivered by a Caesarean Section. ### Claim 7 (depends on 1) The method according to claim 1, wherein said infant is a newborn selected from pre-term infant and term infant. ### Claim 8 (depends on 1) The method of claim 1, wherein in said vegetable-derived fat source at least 13% w/w of the total fatty acid moieties at the sn-2 position of the triglyceride backbone are palmitic acid moieties. ### Claim 9 (depends on 1) The method of claim 1, wherein said vegetable-derived fat source comprises a fat base blended with a mixture of vegetable oils, wherein said mixture comprises oils selected from the group consisting of soy, palm tree, canola, coconut, palm kernel, sunflower, corn, safflower and rapeseed oil. ### Claim 10 (depends on 9) The method of claim 9, wherein said vegetable oils may be randomized before blending with the fat base. ### Claim 11 (depends on 1) The method of claim 1, wherein said vegetable-derived fat source is comprised in any one of food article and infant formula, wherein said food article is selected from bakery products, including bread, particularly biscuits and pastries, human milk fat substitute, dairy products, including milk and dairy drinks, ice cream, cereal products, sauces, soup, spreads, including margarine, fillings, oils and fats, soy products, meat products, fried food products, confectionery products, bars, candy bars, candies and chocolates, snacks, drinks and shakes, instant products, instant drink products, frozen food, prepared foods for infants, toddlers and young children, including prepared cooked mashed vegetables and/or fruits, condiment products, and cooking oils and fats. ### Claim 12 (depends on 11) The method of claim 11, wherein said infant formula comprises said vegetable-derived fat source, together with a protein source, a carbohydrate source, minerals, vitamins and optionally at least one of carrier, diluent, additive or excipient. ### Claim 13 (depends on 1) The method of claim 1, wherein the at least one disorder in the immune system is selected from asthma, eczema, rhinitis, and atopic dermatitis and the lipid composition is effective to treat the disorder.