Enteral formulation: low in fat and containing protein hydrolysates

• US 5,998,363 A
• Filed: 10/08/1998
• Issued: 12/07/1999
• Est. Priority Date: 10/27/1995
• Status: Expired due to Fees

• Current Assignee: Beth Israel Deaconess Medical Center, Inc. (Beth Israel Lahey Health, Inc.)
• Original Assignee: Beth Israel Deaconess Medical Center, Inc. (Beth Israel Lahey Health, Inc.)
• Inventors: Burke, Peter, Bell, Stacey J., Forse, R. Armour
• Primary Examiner(s): HENLEY III, RAYMOND J
• Application Number:
  US09/168,796
• Time in Patent Office: 425 Days
• Field of Search: 514/2, 514/23, 514/54, 514/60, 514/549, 514/552, 514/558, 514/560
• US Class Current: 514/5.5
• 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 2250/154 Water
• CPC Class Codes: A23V 2250/156 Mineral combination undefined extract A23V2250/1638
• CPC Class Codes: A23V 2250/16 Potassium
• CPC Class Codes: A23V 2250/1614 Sodium
• CPC Class Codes: A23V 2250/1872 Linoleic acid
• CPC Class Codes: A23V 2250/1882 Polyunsaturated fatty acids
• CPC Class Codes: A23V 2250/5118 Starch
• CPC Class Codes: A23V 2250/54242 Alpha lactalbumin
• CPC Class Codes: A23V 2250/54246 Casein
• CPC Class Codes: A23V 2250/54252 Whey protein
• CPC Class Codes: A23V 2250/5428 Egg protein
• CPC Class Codes: A23V 2250/70 Vitamins
• 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 31/20 having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
• CPC Class Codes: A61K 31/715 Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
• CPC Class Codes: A61K 38/012 from animals
• CPC Class Codes: A61K 38/018 from milk

Abstract

An improved enteral formulation that is low in fat and contains protein hydrolysates has been developed. The osmolality of the formulation is controlled to be below 500 mOs/kg H₂ O, preferably about 300 mOs/kg H₂ O. In a preferred embodiment, the formulation contains corn starch to control blood glucose levels. This formulation is particularly useful for treatment of critically ill patients and in minimizing a risk of pulmonary aspiration and/or gastrointestinal dysfunction in such patients.

Claims

1. A method of treating critically ill patients comprising the step of administering an enteral formulation to said patient, said enteral formulation comprising about 2-4g/l fat, about 50-100 g/l protein hydrolysate, about 160-250 g/l carbohydrate, and water,

whereby the osmolality of said enteral formulation is controlled to be 250-500 mOs/kg H₂ O.

2. The method of claim 1, wherein the osmolality of said enteral formulation is controlled to be between about 300-400 mOs/kg H₂ O.

3. The method of claim 1, wherein the osmolality of said enteral formulation is controlled to be about 300 mOs/kg H₂ O.

4. The method of claim 1, wherein the fat content of said enteral formulation is about 3 g/l fat.

5. The method of claim 1, wherein the fat in said enteral formulation is selected from the group consisting of safflower, sunflower, corn, olive, menhaden, coconut oil, canola oil, peanut oil and mixtures thereof.

6. The method of claim 5, wherein said fat is selected from high linoleic and alpha linoleic acid safflower and sunflower oil.

7. The method of claim 5, wherein said fat provides all essential fatty acids.

8. The method of claim 2, wherein 3-10 g/l of the total carbohydrates of said enteral formulation are derived from corn starch.

9. The method of claim 8, wherein 3-6 g/l of the total carbohydrates of said enteral formulation are derived from corn starch.

10. The method of claim 1, wherein the source of carbohydrates of said enteral formulation supplies monosaccharides, disaccharides, and oligosaccharides.

11. The method of claim 1, wherein said enteral formulation further comprises about 10-40 mEq/l of a salt containing Na+ ions and about 10-40 mEq/l of a salt containing K+ ions.

12. The method of claim 1, wherein said enteral formulation further comprises a vitamin or mineral.

13. The method of claim 1, wherein said critically ill patients have a critical state induced by trauma, cancer, acute diabetes, malnutrition, AIDS, and sepsis.

14. The method of claim 13, wherein said trauma state is induced by surgery.

15. The method of claim 1, wherein said critically ill patients are patients with gastrointestinal dysfunction.

16. The method of claim 1, wherein said protein hydrolysate comprises less than about 10% of free amino acids.

17. A method of controlling blood sugar levels in patients comprising administering an enteral formulation to said patients, said enteral formulation comprising about 2-4g/l fat, about 50-100 g/l a protein hydrolysate, about 160-250 g/l carbohydrate, wherein about 3-6 g/l of said carbohydrate are from corn starch, and water,

whereby the osmolality of said enteral formulation is controlled to be 250-500 mOs/kg H₂ O.