Nutritional composition for use in therapy of cancer patients

Patent metadata

Field	Value
Publication number	US-11058657-B2
Application number	US-201716349857-A
Country	US
Kind code	B2
Filing date	Nov 16, 2017
Priority date	Nov 16, 2016
Publication date	Jul 13, 2021
Grant date	Jul 13, 2021

Abstract

The invention relates to PUFA, vitamin E, vitamin D and the protein bound amino acids glycine, arginine and tryptophan as active ingredients for use in therapy of cancer patients, wherein an effective amount of said active ingredients is administered in the form of a nutritional composition comprising a) a lipid component providing 40-50 EN % based on the total energy of the nutritional composition, wherein 12-16 EN % based on the total energy of the nutritional composition is provided by PUFA, b) 4.0-8.0 mg/100 mL alpha-TE vitamin E, c) 5.0-12.0 μg/100 mL vitamin D, d) 2.5-4.5 g/100 mL glycine, e) 0.5-1.5 g/100 mL arginine, and f) at least 0.02 g/100 mL tryptophan.

First claim

The invention claimed is:

1. A method for providing nutritional therapy to cancer patient, said method comprising administering a nutritional composition to said cancer patient, said composition comprising a) A lipid component providing 44-46 EN % based on the total energy of the nutritional composition, of which 2-4 EN % is provided by SFA, 13-15 EN % is provided by PUFA, 26-30 EN % is provided by MUPA, based on the total energy of the nutritional composition, wherein the lipid component is rapeseed oil, b) 2.2-2.6 g/100 mL proline, c) 0.02-0.05 g/100 ml cysteine, d) 3.2-3.7 g/100 mL glycine, e) 0.9-1.2 g/100 mL arginine, f) 0.04-0.07/100 mL tryptophan, g) a protein component providing 19-21 EN % based on the total energy of the nutrition composition, wherein the protein component is composed of 80% of collagen hydrolysate and 20% of milk protein, h) a carbohydrate component provide 34-36 EN % based on the total energy of the nutritional composition, i) calcium 150-175 mg/100 mL, j) zinc 3.0-4.0 mg/100 mL, k) copper 480-540 μg/100 mL, l) selenium 20-25 μg/100 mL, m) Vitamin D3 7.5-8.5 μg/100 mL, n) Vitamin E 5.5-6.0 mg/100 mL, o) Vitamin B6 0.55-0.62 mg/100 mL, p) Vitamin B12 1.0-1.2 μg/100 ml, q) Folic acid 60-75 μg/100 mL, r) Vitamin C 35-50 mg/100 mL, s) and water 50-60 ml/100 mL, wherein the glycine, arginine, tryptophan, proline and cysteine are those bond in collagen hydrolysate or milk protein.

2. A method of claim 1 , said composition comprising a) A lipid component providing 45 EN % based on the total energy of the nutritional composition, of which 3 EN % is provided by SFA, 14 EN % is provided by PUFA, 28 EN % is provided by MUPA, based on the total energy of the nutritional composition, wherein the lipid component is rapeseed oil, b) 2.38 g/100 mL proline, c) 0.03 g/100 ml cysteine, d) 3.42 g/100 mL glycine, e) 1.05 g/100 mL arginine, f) 0.05/100 mL tryptophan, g) a protein component providing 20 EN % based on the total energy of the nutrition composition, wherein the protein component is composed of 80% of collagen hydrolysate and 20% of milk protein, h) a carbohydrate component provide 35 EN % based on the total energy of the nutritional composition, i) calcium 160 mg/100 mL, j) zinc 3.5 mg/100 mL, k) copper 512 μg/100 mL, l) selenium 23 μg/100 mL, m) Vitamin D3 8 μg/100 mL, n) Vitamin E 5.67 mg/100 mL, o) Vitamin B6 0.58 mg/100 mL, p) Vitamin B12 1.1 μg/100 ml, q) Folic acid 67.2 μg/100 mL, r) Vitamin C 41.6 mg/100 mL, s) water 56 ml/100 mL, wherein the glycine, arginine, tryptophan, proline and cysteine are those bond in collagen hydrolysate or milk protein.

3. The method of claim 1 , wherein said composition further comprising: Sodium 100-125 mg/100 mL, Potassium 200-340 mg/100 mL, Chloride 130-160 mg/100 mL, Magnesium 35-45 mg/100 mL, Phosphorus 100-125 mg/100 mL, Iron 4.3-5.2, Manganese 0.9-1.5 mg/100 mL, Iodide 40-50 μg/100 mL, Fluoride 0.35-0.45 mg/100 mL, Chromium 20-25 μg/100 mL, Molybdenum 27-35 μg/100 mL, Vitamin A 200-250 μg/100 mL, Beta carotene 400-450 μg/100 mL, Vitamin K 17-25 μg/100 mL, Vitamin B1 0.45-0.55 mg/100 mL, Vitamin B2 0.47-0.55 mg/100 mL, Niacin 5.0-5.8 mg/100 mL, Pantothenic acid 1.80-2.10 mg/100 mL, and Biotin 13.0-16.0 μg/100 mL.

4. The method of claim 3 , wherein the composition comprises Sodium 112 mg/100 mL, calcium 160 mg/100 mL, zinc 3.5 mg/100 mL, copper 512 μg/100 mL, selenium 23 μg/100 mL, Vitamin D3 8 μg/100 mL, n) Vitamin E 5.67 mg/100 mL, Vitamin B6 0.58 mg/100 mL, Vitamin B12 1.1 μg/100 mL, q) Folic acid 67.2 μg/100 mL, Vitamin C 41.6 mg/100 mL, and water 56 ml/100 mL, Potassium 312 mg/100 mL, Chloride 144 mg/100 mL, Magnesium 40 mg/100 mL, Phosphorus 112 mg/100 mL, Iron 4.8, Manganese 1.2 mg/100 mL, Iodide 44.8 μg/100 mL, Fluoride 0.4 mg/100 mL, Chromium 23 μg/100 mL, Molybdenum 30.4 μg/100 mL, Vitamin A 224 μg/100 mL, Beta carotene 426 μg/100 mL, Vitamin K 20.8 μg/100 mL, Vitamin B1 0.5 mg/100 mL, Vitamin B2 0.51 mg/100 mL, Niacin 5.4 mg/100 mL, Pantothenic acid 1.92 mg/100 mL, and Biotin 14.40 μg/100 mL.

5. The method of claim 1 , wherein the nutritional composition is nutritionally complete.

6. The method of claim 1 , wherein the cancer patients have a BMI of <22 kg/m 2 , if they are 70 years or older, and a BMI of <20 kg/m2, if they are younger than 70 years.

7. The method of claim 1 , wherein the cancer patients have an FFMI of <16 kg/m2, if they are female, and an FFMI of <18 kg/m 2 , if they are male.

8. The method of claim 1 , wherein the nutritional composition is administered in a daily dose of 1500-2500 kcal or in a daily dose of 300-900 kcal or in a daily dose of 75-125 g of protein or in a daily dose of 15-45 g of protein.

9. A method of rescuing atrophy induced by tumor necrosis factor while increasing protein synthesis in cancer patients, said method comprising administering a nutritional composition to said cancer patient, wherein said composition comprising a) A lipid component providing 44-46 EN % based on the total energy of the nutritional composition, of which 2-4 EN % is provided by SFA, 13-15 EN % is provided by PUFA, 26-30 EN % is provided by MUPA, based on the total energy of the nutritional composition, wherein the lipid component is rapeseed oil, b) 2.2-2.6 g/100 mL proline, c) 0.02-0.05 g/100 ml cysteine, d) 3.2-3.7 g/100 mL glycine, e) 0.9-1.2 g/100 mL arginine, f) 0.04-0.07/100 mL tryptophan, g) a protein component providing 19-21 EN % based on the total energy of the nutrition composition, wherein the protein component is composed of 80% of collagen hydrolysate and 20% of milk protein, h) a carbohydrate component provide 34-36 EN % based on the total energy of the nutritional composition, i) calcium 150-175 mg/100 mL, j) zinc 3.0-4.0 mg/100 mL, k) copper 480-540 μg/100 mL, l) selenium 20-25 μg/100 mL, m) Vitamin D3 7.5-8.5 μg/100 mL, n) Vitamin E 5.5-6.0 mg/100 mL, o) Vitamin B6 0.55-0.62 mg/100 mL, p) Vitamin B12 1.0-1.2 μg/100 ml, q) Folic acid 60-75 μg/100 mL, r) Vitamin C 35-50 mg/100 mL, and s) water 50-60 ml/100 mL, wherein the glycine, arginine, tryptophan, proline and cysteine are those bond in collagen hydrolysate or milk protein.

10. A dose unit comprising a nutritional composition comprising a) A lipid component providing 44-46 EN % based on the total energy of the nutritional composition, of which 2-4 EN % is provided by SFA, 13-15 EN % is provided by PUFA, 26-30 EN % is provided by MUPA, based on the total energy of the nutritional composition, wherein the lipid component is rapeseed oil, b) 2.2-2.6 g/100 mL proline, c) 0.02-0.05 g/100 ml cysteine, d) 3.2-3.7 g/100 mL glycine, e) 0.9-1.2 g/100 mL arginine, f) 0.04-0.07/100 mL tryptophan, g) a protein component providing 19-21 EN % based on the total energy of the nutrition composition, wherein the protein component is composed of 80% of collagen hydrolysate and 20% of milk protein, h) a carbohydrate component provide 34-36 EN % based on the total energy of the nutritional composition, i) calcium 150-175 mg/100 mL, j) zinc 3.0-4.0 mg/100 mL, k) copper 480-540 μg/100 mL, l) selenium 20-25 μg/100 mL, m) Vitamin D3 7.5-8.5 μg/100 mL, n) Vitamin E 5.5-6.0 mg/100 mL, o) Vitamin B6 0.55-0.62 mg/100 mL, p) Vitamin B12 1.0-1.2 μg/100 ml, q) Folic acid 60-75 μg/100 mL, r) Vitamin C 35-50 mg/100 mL, and s) water 50-60 ml/100 mL, wherein the glycine, arginine, tryptophan, proline and cysteine are those bond in collagen hydrolysate or milk protein.

11. The dose unit of claim 10 , wherein the nutritional is a ready to use nutritional composition.

12. The dose unit of claim 10 , wherein dose unit is 100-200 mL, or a dose unit providing 300-500 kcal, or a dose unit providing 15-30 g of protein.

13. The dose unit of claim 10 , said dose unit is 125 mL and

Assignees

• Fresenius Kabi Deutschland Gmbh

Inventors

• Brito-De-La Fuente Edmundo
• Pestana Ericka
• Ashley-Maguire Sarah
• Mainou-Sierra Jose Maria
• Martinez-Bock Maria Fernanda
• Reichart Stephanie

Classifications

• A61K35/20

  Milk; Whey; Colostrum · CPC title

• A61K38/014

  from connective tissue peptides, e.g. gelatin, collagen · CPC title

• A23L29/045

  containing nitrogen as heteroatom · CPC title

• A23L29/04

  Fatty acids or derivatives · CPC title

• A61P35/00

  Antineoplastic agents · CPC title