Infant formulas for early brain development

• US 20080003330A1
• Filed: 06/30/2006
• Published: 01/03/2008
• Est. Priority Date: 06/30/2006
• Status: Abandoned Application

• Current Assignee: Abbott Laboratories
• Original Assignee: Abbott Laboratories
• Inventors: Barranco, Alejandro, Valverde, Eduardo, Prieto, Pedro, Dohnalek, Margaret H., Rueda, Ricardo, Ramirez, Maria, Vazquez, Enrique
• Application Number:
  US11/479,621
• Publication Number:
  US 20080003330A1
• Time in Patent Office: Days
• US Class Current: 426/72
• CPC Class Codes: A23L 33/12 Fatty acids or derivatives thereof
• CPC Class Codes: A23L 33/19 Dairy proteins
• CPC Class Codes: A23L 33/40 Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
• CPC Class Codes: A61K 31/202 having three or more double bonds, e.g. linolenic eicosanoids, e.g. leukotrienes A61K31/557
• CPC Class Codes: A61K 31/28 Compounds containing heavy metals
• CPC Class Codes: A61K 31/685 one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
• CPC Class Codes: A61K 31/7008 Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
• CPC Class Codes: A61K 31/7032 attached to a polyol, i.e. compounds having two or more free or esterified hydroxy groups, including the hydroxy group involved in the glycosidic linkage, e.g. monoglucosyldiacylglycerides, lactobionic acid, gangliosides
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Disclosed are infant formulas comprising fat, protein, carbohydrate, vitamins, and minerals, including on an as-fed basis, at least about 5 mg/L of gangliosides, at least about 150 mg/L of phospholipids, at least about 70 mg/L of total sialic acid with at least about 2.5% as lipid-bound sialic acid, at least about 0.13% docosahexaenoic acid by weight of total fatty acids, and at least about 0.25% arachidonic acid by weight of total fatty acids. Also disclosed are methods of accelerating brain development, neural migration, and cognitive development in an infant by administering the infant formulas during the first 2-4 months of life, preferably as a sole source of nutrition.

Claims

1. Infant formula comprising fat, protein, carbohydrate, vitamins, and minerals, including, on an as-fed basis:

(A) at least about 5 mg/L of gangliosides,

(B) at least about 150 mg/L of phospholipids,

(C) at least about 70 mg/L of total sialic acid with at least about 2.5% by weight of the sialic acid as lipid-bound sialic acid,

(D) at least about 0.13% docosahexaenoic acid by weight of total fatty acids, and

(E) at least about 0.25% arachidonic acid by weight of the total fatty acids.

2. An infant formula according to claim 1 wherein from about 50% to 100% by weight of the combination of gangliosides, phospholipids, and sialic acid is from an enriched whey protein concentrate.

3. An infant formula according to claim 1 wherein the lipid-bound sialic acid represents from about 2.7% to about 5% by weight of the total sialic acid.

4. An infant formula according to claim 1 comprising, on an as-fed basis, (A) from about 7 mg/L to about 50 mg/L of gangliosides, (B) from about 200 mg/L to about 600 mg/L of phospholipids, and (C) from about 90 mg/L to about 250 mg/L of sialic acid.

5. An infant formula according to claim 1 comprising, by weight of total fatty acids, from about 0.4% to about 2.0% arachidonic acid and from about 0.15% to about 1.0% of docosahexaenoic acid.

6. An infant formula according to claim 1 wherein the total phospholipid comprises at least 20% by weight of sphingomyelin.

7. An infant formula according to claim 6 wherein the phospholipid comprises sphingomyelin, phosphatidyl ethanolamine, phosphatidyl choline, phosphatidyl inositol, and phosphatidyl serine.

8. An infant formula according to claim 1 wherein the formula comprises less than about 0.5% by weight of free glycomacropeptides, on an as-fed basis.

9. An infant formula according to claim 1 wherein the infant formula is substantially free of soy phospholipids, egg phospholipids, and combinations thereof.

10. An infant formula according to claim 1 wherein the formula contains less than about 0.2% by weight of milk fat.

11. An infant formula according to claim 1 wherein the infant formula is a powder.

12. An infant formula according to claim 1 wherein the infant formula is a ready-to-feed liquid.

24. A method of accelerating neural migration in an infant, comprising adminstering or instructing a caregiver to administer as a sole source of nutrition the infant formula of claim 1 to an infant during the first 4 months of life.

25. A method of accelerating vision development in an infant, comprising adminstering or instructing a caregiver to administer as a sole source of nutrition the infant formula of claim 1 to an infant during the first 4 months of life.

26. A method of accelerating cognitive development in an infant, comprising adminstering or instructing a caregiver to administer as a sole source of nutrition the infant formula of claim 1 to an infant during the first 4 months of life.

13. A method of accelerating brain development in an infant, comprising

(I) preparing an infant formula comprising fat, protein, carbohydrate, vitamins, and minerals, including, on an as-fed basis:

(A) at least about 5 mg/L of gangliosides,

(B) at least about 150 mg/L of phospholipids,

(C) at least about 70 mg/L of total sialic acid with at least about 2.5% by weight of the sialic acid as lipid-bound sialic acid,

(D) at least about 0.13% docosahexaenoic acid by weight of total fatty acids, and

(E) at least about 0.25% arachidonic acid by weight of the total fatty acids.

(II) administering or instructing a caregiver to administer the formula to an infant during the first 2 months of life.

14. A method according to claim 13 wherein the formula is administered during the first 4 months of life.

15. A method according to claim 14 wherein from about 50% to 100% by weight of the combination of gangliosides, phospholipids, and sialic acid is from an enriched whey protein concentrate.

16. A method according to claim 14 wherein the lipid-bound sialic acid represents from about 2.7% to about 5% by weight of the total sialic acid.

17. A method according to claim 14, wherein the infant formula comprises, on an as-fed basis, (A) from about 7 mg/L to about 50 mg/L of gangliosides, (B) from about 200 mg/L to about 600 mg/L of phospholipids, and (C) from about 90 mg/L to about 250 mg/L of sialic acid.

18. A method according to claim 14 wherein the formula comprises, by weight of total fatty acids, from about 0.4% to about 2.0% arachidonic acid and from about 0.15% to about 1.0% of docosahexaenoic acid.

19. A method according to claim 14 wherein the total phospholipid comprises at least 20% by weight of sphingomyelin.

20. A method according to claim 14 wherein the phospholipid comprises sphingomyelin, phosphatidyl ethanolamine, phosphatidyl choline, phosphatidyl inositol, and phosphatidyl serine.

21. A method according to claim 14 wherein the formula contains less than about 0.2% by weight of milk fat.

22. A method according to claim 14 wherein the formula contains less than about 0.5% by weight of free glycomacropeptides.

23. A method according to claim 14 wherein the infant formula is substantially free of soy phospholipids and egg phospholipids.