# US 9,433,661 B2 · Insulin-containing infant formula > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,433,661 B2 - Document ID: US9433661B2 - Status: Granted - Kind: B2 - Application number: 14/872,460 - Filed: 2015-10-01 - Published: 2016-01-28 - Granted: 2016-09-06 - Earliest claimed: 2012-05-31 - Assignees: Nutrinia Ltd. - Applicants: Nutrinia Ltd. - Inventors: Mario Guralnik; Naim Shehadeh; Michal Olshansky - Web page: https://patentgrep.com/patent/US9433661B2 ## CPC - A61K 38/28: Insulins - A23L 33/18: Peptides; Protein hydrolysates - A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula} - A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin - 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) - A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION ## Abstract The present invention provides compositions methods and kits for improved infant formula, particularly to insulin-supplements and formulae comprising same that mimic the diurnal rhythm and/or the postpartum variation of insulin in human milk. ## Claims ### Claim 1 A kit for insulin-supplemented infant formula, comprising: a plurality of portions of infant formula, wherein each portion comprises insulin, wherein the concentration of the insulin in each of the plurality of portions mimics the concentration of insulin in human milk at a given day and time of day postpartum, wherein the day is between day 1 to day 84 postpartum, wherein the time of day is selected from 6 AM to 12 PM, 12 PM to 6 PM, 6 PM to 12 AM, 6 AM to 6 PM and 6 PM to 6 AM; and instructions for feeding an infant with the insulin-supplemented infant formula. ### Claim 2 (depends on 1) The kit of claim 1, wherein the concentration of insulin in each portion of formula corresponds to the concentration range of insulin indicated at a given day and time of day in Table 1. ### Claim 3 (depends on 1) The kit of claim 1, wherein the concentration of insulin in each portion of formula corresponds to the mean concentration of insulin indicated at a given day and time of day in Table 1. ### Claim 4 (depends on 1) The kit of claim 1, wherein the day is between day 1 to day 30 postpartum. ### Claim 5 (depends on 1) The kit of claim 1, wherein the day is between day 30 to day 84 postpartum. ### Claim 6 (depends on 4) The kit of claim 4, wherein the concentration of insulin in each portion of the formula is selected from (i) a concentration that is 10% higher than the mean concentration of the insulin measured between 6 AM to 6 PM at a given day postpartum and (ii) a concentration that is 10% lower than the average concentration of the insulin measured between 6 PM to 12 AM at a given day postpartum. ### Claim 7 (depends on 4) The kit of claim 4, wherein the concentration of insulin in each portion of formula is selected from (i) a concentration corresponding to the mean concentration of insulin indicated at a given day and time of day in Table 2 (ii) a concentration that is 10% higher than the mean concentration of the insulin measured between 6 AM to 6 PM at a given day in Table 2 and (ii) a concentration that is 10% lower than the average concentration of the insulin measured between 6 PM to 12 AM at a given day in Table 2. ### Claim 8 (depends on 1) The kit of claim 1, wherein the insulin is encapsulated in an encapsulating matrix. ### Claim 9 (depends on 8) The kit of claim 8, wherein the encapsulating matrix comprises encapsulating material selected from the group consisting of polysaccharide, milk powder, whey protein, lipid, gum Arabic, or microcrystalline cellulose. ### Claim 10 (depends on 8) The kit of claim 8, wherein the encapsulating material is maltodextrine, and wherein the matrix further comprises anti-oxidant. ### Claim 11 (depends on 1) The kit of claim 1, wherein the insulin is biologically active. ### Claim 12 (depends on 1) The kit of claim 1, wherein the insulin is mammalian insulin selected from the group consisting of human insulin and bovine insulin. ### Claim 13 (depends on 1) The kit of claim 1, wherein the formula is in a form selected from the group consisting of: dry powder for reconstitution with water, liquid concentrate for reconstitution with water and liquid ready-to-feed formula. ### Claim 14 A kit for insulin-supplemented infant formula, comprising: a plurality of portions of infant formula; a plurality of portions of insulin; and instructions for how to mix the insulin with the formula such that the insulin concentration in the formula mimics the concentration of insulin in human milk at a given day and time of day postpartum, wherein the day is between day 1 to day 84 postpartum, wherein the time of day is selected from 6 AM to 12 PM, 12 PM to 6 PM, 6 PM to 12 AM, 6 AM to 6 PM and 6 PM to 6 AM. ### Claim 15 (depends on 14) The kit of claim 14, wherein the concentration of insulin in each portion of insulin corresponds to the concentration range of insulin indicated at a given day and time of day in Table 1. ### Claim 16 (depends on 14) The kit of claim 14, wherein the concentration of insulin in each portion of insulin corresponds to the mean concentration of insulin indicated at a given day and time of day in Table 1. ### Claim 17 (depends on 14) The kit of claim 14, wherein the insulin is encapsulated in an encapsulating matrix. ### Claim 18 (depends on 14) The kit of claim 14, wherein the insulin is biologically active. ### Claim 19 (depends on 14) The kit of claim 14, wherein the formula is in a form selected from the group consisting of: dry powder for reconstitution with water, liquid concentrate for reconstitution with water and liquid ready-to-feed formula. ### Claim 20 A kit for insulin-supplemented infant formula, comprising a plurality of portions of infant formula, a plurality of portions of insulin; and instructions for how to mix the insulin with the formula such that the insulin concentration in the formula mimics the concentration of insulin in human milk at a given time period postpartum, wherein the time period postpartum is selected from day 0-5, 6-15, 16-30, 31-60, 61-90.