Pediatric formula and methods for providing nutrition and improving tolerance

• US 6,365,218 B1
• Filed: 02/04/2000
• Issued: 04/02/2002
• Est. Priority Date: 02/04/2000
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Luebbers, Steven T., Black, Cynthia J., McKamy, Daniel L., Borschel, Marlene W., Costigan, Timothy
• Primary Examiner(s): HEGGESTAD, HELEN F
• Application Number:
  US09/498,350
• Time in Patent Office: 788 Days
• Field of Search: 426/72, 426/74, 426/573, 426/801
• US Class Current: 426/573
• CPC Class Codes: A23L 29/27 Xanthan not combined with other microbial gums
• CPC Class Codes: A23L 33/18 Peptides; Protein hydrolysates
• CPC Class Codes: A23L 33/40 Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2250/156 Mineral combination undefined extract A23V2250/1638
• CPC Class Codes: A23V 2250/1944 Medium-chain triglycerides
• CPC Class Codes: A23V 2250/5086 Xanthan
• CPC Class Codes: A23V 2250/5114 Dextrins, maltodextrins
• CPC Class Codes: A23V 2250/5424 Dairy protein
• CPC Class Codes: A23V 2250/70 Vitamins
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: Y10S 426/801 Pediatric

Abstract

The present invention provides an improved pediatric formula and methods for providing nutrition to and enhancing tolerance in pediatric patients. The formula may be provided in powder, concentrate or ready-to-feed forms. The pediatric formula comprises, based on a 100 kcal basis, about 8 to about 16 grams carbohydrate (preferably about 9.4 to about 12.3 grams), about 3 to about 6 grams lipid (preferably about 4.7 to about 5.6 grams), about 1.8 to about 3.3 grams protein (preferably about 2.4 to about 3.3 grams), and a tolerance improver comprising about 37 to about 370 milligrams (preferably about 74 to about 222 milligrams, more preferably about 111 to about 148 milligrams) xanthan gum. The formula may also be provided in a powder, which comprises, based on 100 grams of powder, about 30 to about 90 grams carbohydrate (preferably about 48 to about 59), about 15 to about 30 grams lipid (preferably 22 to about 28 grams), about 8 to about 17 grams protein (preferably about 11 to about 17), and about 188 to about 1880 milligrams (preferably about 375 to about 1125, more preferably about 375 to about 1125 milligrams) xanthan gum. The formula preferably further comprises vitamins and minerals and may further comprise a stabilizer. The methods comprise administering to a pediatric patient an effective amount of a pediatric formula according to the invention, as described above.

Claims

1. A pediatric formula comprising, based on a 100 kcal basis:

about 8 to about 16 grams carbohydrate, about 3 to about 6 grams lipid, about 1.8 to about 3.3 grams protein, and a tolerance improver, consisting of a single hydrocolloid which is selected from the group consisting of xanthan gum in the amounts of about 37 to 370 milligrams.

2. A pediatric formula as defined in claim 1 wherein the xanthan gum comprises from about 74 to about 222 milligrams.

3. A pediatric formula as defined in claim 1 wherein the xanthan gum comprises from about 111 to about 148 milligrams.

4. A pediatric formula as defined in claim 1 wherein the carbohydrate comprises from about 9.4 to about 12.3 grams.

5. A pediatric formula as defined in claim 1 wherein the lipid comprises from about 4.7 to about 5.6 grams.

6. A pediatric formula as defined in claim 1 wherein the protein comprises from about 15 2.4 to about 3.3 grams.

7. A pediatric formula as defined in claim 1 further comprising vitamins and minerals.

8. A pediatric formula as defined in claim 1 wherein the vitamins and minerals are selected from the group consisting of calcium, phosphorus, sodium, chloride, magnesium, manganese, iron, copper, zinc, selenium, iodine, Vitamins A, E, C, D, K and the B complex, and mixtures thereof.

9. A pediatric formula as defined in claim 1 wherein the lipid is selected from the group consisting of coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm oil, palm olein, canola oil, lipid sources of arachidonic acid and docosahexaneoic acid, and mixtures thereof.

10. A pediatric formula as defined in claim 1 wherein the protein comprises intact protein selected from the group consisting of soy based protein, milk based protein, casein protein, whey protein, rice protein, beef collagen, pea protein, potato protein, and mixtures thereof.

11. A pediatric formula as defined in claim 1 wherein the protein comprises hydrolyzed protein selected from the group consisting of soy protein hydrolysate, casein protein hydrolysate, whey protein hydrolysate, rice protein hydrolysate, potato protein hydrolysate, fish protein hydrolysate, egg albumen hydrolysate, gelatin protein hydrolysate, a combination of animal and vegetable protein hydrolysates, and mixtures thereof.

12. A pediatric formula as defined in claim 1 wherein the protein comprises free amino acids selected from the group consisting of tryptophan, tyrosine, cystine, taurine, L-methionine, L-arginine, and carnitine, and mixtures thereof.

13. A pediatric formula as defined in claim 1 wherein the carbohydrate is selected from the group consisting of hydrolyzed, intact, natural and chemically modified starches sourced from corn, tapioca, rice or potato in waxy or non waxy forms;

sugars such as glucose, fructose, lactose, sucrose, maltose, high fructose corn syrup; and

mixtures thereof.

14. A pediatric formula in a powdered form which comprises, based on 100 grams of powder, about 30 to about 90 grams carbohydrate, about 15 to about 30 grams lipid, about 8 to about 17 grams protein, and a tolerance improver consisting of a single hydrocolloid which is selected from the group consisting of xanthan gum in amounts of about 188 to about 1880 milligrams.

15. A pediatric formula as defined in claim 14 wherein the xanthan gum comprises from about 375 to about 1125 milligrams.

16. A pediatric formula as defined in claim 14 wherein the xanthan gum comprises from about 565 to about 750 milligrams.

17. A pediatric formula as defined in claim 14 wherein the carbohydrate comprises from about 48 to about 59 grams.

18. A pediatric formula as defined in claim 14 wherein the lipid comprises from about 22 to about 28 grams.

19. A pediatric formula as defined in claim 14 wherein the protein comprises from about 11 to about 17 grams.

20. A pediatric formula as defined in claim 14 further comprising vitamins and minerals.

21. A pediatric formula as defined in claim 14 wherein the vitamins and minerals are selected from the group consisting of calcium, phosphorus, sodium, chloride, magnesium, manganese, iron, copper, zinc, selenium, iodine, Vitamins A, E, C, D, K and the B complex, and mixtures thereof.

22. A pediatric formula as defined in claim 14 wherein the lipid is selected from the group consisting of coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm oil, palm olein, canola oil, lipid sources of arachidonic acid and docosahexaneoic acid, and mixtures thereof.

23. A pediatric formula as defined in claim 14 wherein the protein comprises intact protein selected from the group consisting of soy based protein, milk based protein, casein protein, whey protein, rice protein, beef collagen, pea protein, potato protein, and mixtures thereof.

24. A pediatric formula as defined in claim 14 wherein the protein comprises hydrolyzed protein selected from the group consisting of soy protein hydrolysate, casein protein hydrolysate, whey protein hydrolysate, rice protein hydrolysate, potato protein hydrolysate, fish protein hydrolysate, egg albumen hydrolysate, gelatin protein hydrolysate, a combination of animal and vegetable protein hydrolysates, and mixtures thereof.

25. A pediatric formula as defined in claim 14 wherein the protein comprises free amino acids selected from the group consisting of tryptophan, tyrosine, cystine, taurine, L-methionine, L-arginine, and carnitine, and mixtures thereof.

26. A pediatric formula as defined in claim 14 wherein the carbohydrate is selected from the group consisting of hydrolyzed, intact, natural and chemically modified starches sourced from corm, tapioca, rice or potato in waxy or non waxy forms;

sugars such as glucose, fructose, lactose, sucrose, maltose, high fructose corn syrup; and

mixtures thereof.

27. A method for providing nutrition to pediatric patients comprising administering an effective amount of a pediatric formula comprising, based on a 100 kcal basis:

about 8 to about 16 grams carbohydrate, about 3 to about 6 grams lipid, about 1.8 to about 3.3 grams protein, and a tolerance improver consisting of a single hydrocolloid which is selected from the group consisting of xanthan gum in yhe amounts of about 37 to 370 milligrams. about 370 milligrams-xanthan gum.

28. A method as defined in claim 27 wherein the xanthan gum comprises from about 74 to about 222 milligrams.

29. A method as defined in claim 27 wherein the xanthan gum comprises from about 111 to about 148 milligrams.

30. A method as defined in claim 27 wherein the carbohydrate comprises from about 9.4 to about 12.3 grams.

31. A method as defined in claim 27 wherein the lipid comprises from about 4.7 to about 5.6 grams.

32. A method as defined in claim 27 wherein the protein comprises from about 2.4 to about 3.3 grams.

33. A method as defined in claim 27 further comprising vitamins and minerals.

34. A method as defined in claim 33 wherein the vitamins and minerals are selected from the group consisting of calcium, phosphorus, sodium, chloride, magnesium, manganese, iron, copper, zinc, selenium, iodine, Vitamins A, E, C, D, K and the B complex, and mixtures thereof.

35. A method as defined in claim 27 wherein the lipid is selected from the group consisting of coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm oil, palm olein, canola oil, lipid sources of arachidonic acid and docosahexaneoic acid, and mixtures thereof.

36. A method as defined in claim 27 wherein the protein comprises intact protein selected from the group consisting of soy based protein, milk based protein, casein protein, whey protein, rice protein, beef collagen, pea protein, potato protein, and mixtures thereof.

37. A method as defined in claim 27 wherein the protein comprises hydrolyzed protein selected from the. group consisting of soy protein hydrolysate, casein protein hydrolysate, whey protein hydrolysate, rice protein hydrolysate, potato protein hydrolysate, fish protein hydrolysate, egg albumen hydrolysate, gelatin protein hydrolysate, a combination of animal and vegetable protein hydrolysates, and mixtures thereof.

38. A method as defined in claim 27 wherein the protein comprises free amino acids selected from the group consisting of tryptophan, tyrosine, cystine, taurine, L-methionine, L-arginine, and carnitine, and mixtures thereof.

39. A method as defined in claim 27 wherein the carbohydrate is selected from the group consisting of hydrolyzed, intact, natural and chemically modified starches sourced from corn, tapioca, rice or potato in waxy or non waxy forms;

sugars such as glucose, fructose, lactose, sucrose, maltose, high fructose corn syrup; and

mixtures thereof.

40. A method for providing nutrition to pediatric patients comprising administering an effective amount of a pediatric formula reconstituted from a powdered composition which comprises, based on 100 grams of powder, about 30 to about 90 grams carbohydrate, about 15 to about 30 grams fat, about 8 to about 17 grams protein, and a tolerance improver consisting of a single hydrocolloid which is selected from the group consisting of xanthan gum in amounts of about 188 to about 1880 milligrams.

41. A method as defined in claim 40, wherein the xanthan gum comprises from about 375 to about 1125 milligrams.

42. A method as defined in claim 40 wherein the xanthan gum comprises from about 565 to about 750 milligrams.

43. A method as defined in claim 40 wherein the carbohydrate comprises from about 48 to about 59 grams.

44. A method as defined in claim 40 wherein the lipid comprises from about 22 to about 28 grams.

45. A method as defined in claim 40 wherein the protein comprises from about 11 to about 17 grams.

46. A method as defined in claim 40 wherein the formula further comprises vitamins and minerals.

47. A method as defined in claim 46 wherein the vitamins and minerals are selected from the group consisting of calcium, phosphorus, sodium, chloride, magnesium, manganese, iron, copper, zinc, selenium, iodine, Vitamins A, E, C, D, K and the B complex, and mixtures thereof.

48. A method as defined in claim 40 wherein the lipid is selected from the group consisting of coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm oil, palm olein, canola oil, lipid sources of arachidonic acid and docosahexaneoic acid, and mixtures thereof.

49. A method as defined in claim 40 wherein the protein comprises intact protein selected from the group consisting of soy based protein, milk based protein, casein protein, whey protein, rice protein, beef collagen, pea protein, potato protein, and mixtures thereof.

50. A method as defined in claim 40 wherein the protein comprises hydrolyzed protein selected from the group consisting of soy protein hydrolysate, casein protein hydrolysate, whey protein hydrolysate, rice protein hydrolysate, potato protein hydrolysate, fish protein hydrolysate, egg albumen hydrolysate, gelatin protein hydrolysate, a combination of animal and vegetable protein hydrolysates, and mixtures thereof.

51. A method as defined in claim 40 wherein the protein comprises free amino acids selected from the group consisting of tryptophan, tyrosine, cystine, taurine, L-methionine, L-arginine, and carnitine, and mixtures thereof.

52. A method as defined in claim 40 wherein the carbohydrate is selected from the group consisting of hydrolyzed, intact, natural and chemically modified starches sourced from corm, tapioca, rice or potato in waxy or non waxy forms;

and sugars such as glucose, fructose, lactose, sucrose, maltose, high fructose corn syrup; and

mixtures thereof.

53. A method for improving tolerance in pediatric patients comprising administering an effective amount of a pediatric formula comprising, based on a 100 kcal basis:

about 8 to about 16 grams carbohydrate, about 3 to about 6 grams lipid, about 1.8 to about 3.3 grams protein, and a tolerance improver consisting of a single hydrocolloid which is selected from the group consisting of xanthan gum in the amounts of about 37 to 370 milligrams.

54. A method as defined in claim 53 wherein the xanthan gum comprises from about 74 to about 222 milligrams.

55. A method as defined in claim 53 wherein the xanthan gum comprises from about 111 to about 148 milligrams.

56. A method as defined in claim 53 wherein the carbohydrate comprises from about 9.4 to about 12.3 grams.

57. A method as defined in claim 53 wherein the lipid comprises from about 4.7 to about 5.6 grams.

58. A method as defined in claim 53 wherein the protein comprises from about 2.4 to about 3.3 grams.

59. A method as defined in claim 53 further comprising vitamins and minerals.

60. A method as defined in claim 53 wherein the vitamins and minerals are selected from the group consisting of calcium, phosphorus, sodium, chloride, magnesium, manganese, iron, copper, zinc, selenium, iodine, Vitamins A, E, C, D, K and the B complex, and mixtures thereof.

61. A method as defined in claim 53 wherein the lipid is selected from the group consisting of coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm oil, palm olein, canola oil, lipid sources of arachidonic acid and docosahexaneoic acid, and mixtures thereof.

62. A method as defined in claim 53 wherein the protein comprises intact protein selected from the group consisting of soy based protein, milk based protein, casein protein, whey protein, rice protein, beef collagen, pea protein, potato protein, and mixtures thereof.

63. A method as defined in claim 53 wherein the protein comprises hydrolyzed protein selected from the group consisting of soy protein hydrolysate, casein protein hydrolysate, whey protein hydrolysate, rice protein hydrolysate, potato protein hydrolysate, fish protein hydrolysate, egg albumen hydrolysate, gelatin protein hydrolysate, a combination of animal and vegetable protein hydrolysates, and mixtures thereof.

64. A method as defined in claim 53 wherein the protein comprises free amino acids selected from the group consisting of tryptophan, tyrosine, cystine, taurine, L-methionine, L-arginine, and '"'"'carnitine, and mixtures thereof.

65. A method as defined in claim 53 wherein the carbohydrate is selected from the group consisting of hydrolyzed, intact, natural and chemically modified starches sourced from corn, tapioca, rice or potato in waxy or non waxy forms;

sugars such as glucose, fructose, lactose, sucrose, maltose, high fructose corn syrup; and

mixtures thereof.

66. A method of improving tolerance in pediatric patients comprising administering an effective amount of a pediatric formula reconstituted from a powdered composition which comprises, based on 100 grams of powder, about 30 to about 90 grams carbohydrate, about 15 to about 30 grams fat, about 8 to about 17 grams hydrolysate protein, and a tolerance improver consisting of a single hydrocolloid which is selected from the group consisting of xanthan gum in amounts of about 188 to 1880 milligrams.

67. A method as defined in claim 66 wherein the xanthan gum comprises from about 375 to about 1125 milligrams.

68. A method as defined in claim 66 wherein the xanthan gum comprises from about 565 to about 750 milligrams.

69. A method as defined in claim 66 wherein the carbohydrate comprises from about 48 to about 59 grams.

70. As A method as defined in claim 66 wherein the lipid comprises from about 22 to about 28 grams.

71. A method as defined in claim 66 wherein the protein comprises from about 11 to about 17 grams.

72. A method as defined in claim 66 wherein the formula further comprises vitamins and minerals.

73. A method as defined in claim 72 wherein the vitamins and minerals are selected from the group consisting of calcium, phosphorus, sodium, chloride, magnesium, manganese, iron, copper, zinc, selenium, iodine, Vitamins A, E, C, D, K and the B complex, and mixtures thereof.

74. A method as defined in claim 66 wherein the lipid is selected from the group consisting of coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm oil, palm olein, canola oil, lipid sources of arachidonic acid and docosahexaneoic acid, and mixtures thereof.

75. A method as defined in claim 66 wherein the protein comprises intact protein selected from the group consisting of soy based protein, milk based protein, casein protein, whey protein, rice protein, beef collagen, pea protein, potato protein, and mixtures thereof.

76. A method as defined in claim 66 wherein the protein comprises hydrolyzed protein selected from the group consisting of soy protein hydrolysate, casein protein hydrolysate, whey protein hydrolysate, rice protein hydrolysate, potato protein hydrolysate, fish protein hydrolysate, egg albumen hydrolysate, gelatin protein hydrolysate, a combination of animal and vegetable protein hydrolysates, and mixtures thereof.

77. A method as defined in claim 66 wherein the protein comprises free amino acids selected from the group consisting of tryptophan, tyrosine, cystine, taurine, L-methionine, L-arginine, and carnitine, and mixtures thereof.

78. A method as defined in claim 66 wherein the carbohydrate is selected from the group consisting of hydrolyzed, intact, natural and chemically modified starches sourced from corn, tapioca, rice or potato in waxy or non waxy forms;

and sugars such as glucose, fructose, lactose, sucrose, maltose, high fructose corn syrup; and

mixtures thereof.