Method to enhance the immune system of a human

• US 5,602,109 A
• Filed: 01/10/1994
• Issued: 02/11/1997
• Est. Priority Date: 01/10/1994
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Hilty, Milo D., Masor, Marc L.
• Primary Examiner(s): Hollinden, Gary E.
• Assistant Examiner(s): Lee, Howard C.
• Application Number:
  US08/178,686
• Time in Patent Office: 1,128 Days
• Field of Search: 424/195.1, 424/196.1, 424/197.1, 426/2, 426/72, 426/598, 426/801, 514/45, 514/49, 514/885, 536/4.1, 536/22.1, 536/23.1, 536/25.5
• US Class Current: 514/45
• CPC Class Codes: A23C 9/1526 Amino acids; Peptides; Protein hydrolysates; Nucleic acids; Derivatives thereof
• CPC Class Codes: A23L 33/13 Nucleic acids or derivatives thereof A23L33/145 takes precedence
• CPC Class Codes: A23L 33/40 Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/70 Carbohydrates; Sugars; Derivatives thereof sorbitol A61K31/047
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: Y10S 426/801 Pediatric

Abstract

An improved enteral nutritional formula containing ribo-nucleotide equivalents (RNA, mono-, di- and triphosphate nucleotides, nucleosides and adjuncts such as activated sugars) at a level of at least 10 mg/100 Kcal (kilocalorie) of formula is disclosed. The formula comprises carbohydrates, lipids, proteins, vitamins and minerals and four (4) ribo-nucleotide equivalents at specific levels and ratios. The invention also discloses novel methods of production and analytical techniques. This invention also provides a dietary formula that enhances the immune system and alleviates diarrhea.

Claims

1. A method of improving the immune response sensitivity of the the immune system of a human infant, wherein said method comprises feeding a human infant in need of treatment a formula, the improvement comprising feeding said human infant a formula consisting essentially of:

1) protein, said protein being of a concentration of between 10 and 35 grams per liter of formula;

2) fat, said fat being of a concentration of between 20 and 45 grams per liter of formula;

3) carbohydrates, said carbohydrates being of a concentration of between 60 and 110 grams per liter of formula; and

4) at least 70 mg of nucleotide equivalents per liter of formula, said nucleotide equivalents are nucleotide equivalents of each of adenosine, cytidine, guanosine and uridine, and wherein the concentration of said cytidine nucleotide equivalents are in the range of from 29 to 39 mg/liter of said formula, the concentration of said uridine nucleotide equivalents are in the range of from 15 to 20 mg/liter of said formula, the concentration of said adenosine nucleotide equivalents are in the range of from 10 to 15 mg/liter of said formula, and the concentration of said guanosine nucleotide equivalents are in the range of from 14 to 20 mg/liter of said formula.

2. A method as claimed in claim 1 wherein the source of said protein is supplied in a form selected from the group consisting of condensed skim milk, non fat milk, cheese whey, vegetable protein, protein hydrolyzates and mixtures thereof.

3. A method as claimed in claim 1 wherein said protein is of a concentration of between 15 and 21 grams per liter of formula and consists of 50-70% by weight condensed skim milk and 30-50% by weight cheese whey.

4. A method as claimed in claim 1 wherein said fat is supplied in a form selected from the group consisting of soy oil, coconut oil, corn oil, safflower oil, sunflower oil, saltwater fish oils, fungal oils and blends thereof.

5. A method as claimed in claim 1 wherein said fat is of a concentration of between 24 and 38 grams per liter of formula and is a blend of high oleic safflower oil, soy oil and coconut oil.

7. A method according to claim 1 wherein said nucleotide equivalents are in the form of CMP, AMP, GMP and UMP, and are present at a level of up to 1.0 grams per liter of formula.

8. A method according to claim 1 wherein the formula additionally contains 10 to 30 IU of R,R,R, α

-tocophenol per liter of formula, 400-500 μ

g of β

-carotene per liter of formula and 14-32 mcg of selenium per liter of formula.

9. A method according to claim 1 wherein said nucleotide equivalents are present in the following ranges per liter of formula as fed:

cytosine equivalents 30-33 mg;

uridine equivalents 16-19 mg;

adenosine equivalents 11-14 mg and guanosine equivalents 15-18 mg.

6. A method as claimed in claim I wherein said protein is of a concentration of 13 to 15 grams per liter of formula, said fat is of a concentration of 30 to 40 grams per liter of formula and has as its source a blend of soy oils, coconut oils and high oleic safflower oil, and said carbohydrates are of a concentration of 70 to 80 grams per liter of formula, and dietary fiber, said dietary fiber is soy polysaccharide derived from soy beans.

10. A method of improving the immune response sensitivity of the immune system of a human infant, said method comprising feeding a human infant in need of treatment a nutritional formula, the improvement comprising a human infant a nutritionally complete formula comprising:

1) protein;

2) fat;

3) carbohydrates;

4) at least 70 mg of nucleotides per liter of formula, said nucleotides comprising the monophosphate esters of adenosine, cytidine, guanosine and uridine and wherein the weight ratio of CMP;

UMP is at least 1.5;

1;

of CMP;

AMP is at least 2;

1 and of CMP;

GMP is at least 1.75;

1; and

wherein the concentration of said cytidine monophosphate esters are in the range of from 29 to 39 mg/liter of said formula, the concentration of said uridine monophosphate esters are in the range of from 15 to 20 mg/liter of said formula, the concentration of said adenosine monophosphate esters are in the range of from 10 to 15 mg/liter of said formula, and the concentration of said guanosine monophosphate esters are in the range of from 14 to 20 mg/liter of said formula.

11. A method as claimed in claim 10 wherein said monophosphate esters are present in the following ranges per liter of formula as fed:

CMP 30-33 mg;

UMP 16-19 mg;

AMP 11-14 mg and GMP 15-18 mg.

12. A method as claimed in claim 11 wherein said protein is of a concentration of between 13 and 16 grams per liter of formula, said fat is a blend of soy oil, high oleic safflower oil and coconut oil, and said carbohydrate is of a concentration of between 65 and 85 grams per liter of formula and consists of lactose.

13. A method according to claim 10 wherein the formula additionally contains 10 to 30 IU of R,R,R, α

-tocophenol per liter of formula, 400-500 μ

g of β

-carotene per liter of formula and 14-32 mcg of selenate per liter of formula.

14. A method of improving the immune response sensitivity of the immune system of a human infant to an antigen, said method comprising feeding a human infant in need of treatment a nutritional formula, the improvement comprising feeding said human infant an infant formula that contains 29-39 mg of CMP per liter of formula;

15-21 mg of UMP per liter of formula;

10-16 mg of AMP per liter or formula and 14-20 mg of GMP per liter of formula or their nucleotide equivalents and wherein the weight ratio of CMP;

UMP is at least 1.5;

1;

of CMP;

AMP is at least 2;

1; and

of CMP;

GMP is at least 1.75;

1.

15. The method according to claim 14 wherein said human infant formula comprises per liter of formula:

CMP, 30-33 mg

UMP, 16-19 mg

AMP, 11-14 mg

GMP, 15-18 mg.

16. A method for the treatment and prevention of diarrheal disease in human infants which comprises administering to a human infant in need of such treatment an infant formula which comprises a therapeutically effective amount of a source of amino nitrogen, carbohydrates, edible fats, minerals, vitamins and a composition comprising at least one member selected from each of the groups (a), (b), (c), and (d):

(a) uridine, uridine phosphates and mixtures thereof;

(b) guanosine, guanosine phosphates and mixtures thereof;

(c) adenosine, adenosine phosphates and mixtures thereof;

(d) cytidine, cytidine phosphates and mixtures thereof;

wherein the total amount of the composition is at least 70 mg per liter of formula, wherein the concentration of component (a) is in the range of 30-33 mg/liter, the concentration of component (b) is in the range of 16-19 mg/liter, the concentration of component (c) is in the range of 11-14 mg/liter, the concentration of component (d) is in the range of 15-18 mg/liter.

17. A method for the treatment of diarrheal disease in a human infant, wherein said method comprises feeding a human infant in need of treatment a formula, the improvement comprising feeding said human infant a formula consisting essentially of:

1) protein, said protein being of a concentration of between 10 and 35 grams per liter of formula;

2) fat, said fat being of a concentration of between 20 and 45 grams per liter of formula;

3) carbohydrates, said carbohydrates being of a concentration of between 60 and 110 grams per liter of formula; and

4) at least 70 mg of nucleotide equivalents per liter of formula, said nucleotide equivalents are nucleotide equivalents of each of adenosine, cytidine, guanosine and uridine and wherein the concentration of said cytidine nucleotide equivalents are in the range of from 29 to 39 mg/liter of said formula, the concentration of said uridine nucelotide equivalents are in the range of from 15 to 20 mg/liter of said formula, the concentration of said adenosine nucelotide equivalents are in the range of from 10 to 15 mg/liter of said formula, and the concentration of said guanosine nucleotide equivalents are in the range of from 14 to 20 mg/liter of said formula.

18. A method as claimed in claim 17 wherein the source of protein is supplied in a form selected from the group consisting of condensed skim milk, non-fat milk, acid whey and cheese whey.

19. A method as claimed in claim 17 wherein said protein is of a concentration of between 13 and 20 grams per liter of formula and comprising 50-70% by weight condensed skim milk and 30-50% by weight cheese whey.

20. A method as claimed in claim 17 wherein said fat is supplied in a form selected from the group consisting of soy oil, coconut oil, corn oil, safflower oil, saltwater fish oils, egg yolk oils, sunflower oils fungal oils or blends thereof.

21. A method as claimed in claim 19 wherein said fat is of a concentration of between 24 and 38 grams per liter of formula and comprising a blend of high oleic safflower oil, soy oil and coconut oil.

22. A method as claimed in claim 17 wherein said protein is of a concentration of 13 to 15 grams per liter of formula, said fat is of a concentration of 30 to 40 grams per liter of formula and has as its source a blend of soy oils, coconut oils and high oleic safflower oil and, said carbohydrates are of a concentration of 70 to 80 grams per liter of formula.

23. A method as claimed in claim 17 wherein said protein is of a concentration of between 13 and 16 grams per liter of formula, said fat is a blend of soy oil, high oleic safflower oil and coconut oil and said carbohydrate is of a concentration of between 65 and 85 grams per liter of formula and consists of lactose.

24. A method according to claim 17 wherein said infant formula comprises per liter of formula:

CMP, 30-33 mg

UMP, 16-19 mg

AMP, 11-14 mg

GMP, 15-18 mg.