Combination of a leucine source and an omega-3 unsaturated fatty acid source for use in the treatment of hypercalcaemia

Patent metadata

Field	Value
Publication number	US-9867796-B2
Application number	US-201414341106-A
Country	US
Kind code	B2
Filing date	Jul 25, 2014
Priority date	May 27, 2009
Publication date	Jan 16, 2018
Grant date	Jan 16, 2018

Abstract

The present invention relates to a combination of a leucine source and at least one unsaturated fatty acid source for prophylactic or therapeutic treatment of hypercalcaemia. The invention further relates to a combination of a leucine source and at least one unsaturated fatty acid source for reducing or avoiding a reduction in bone mineral density in a subject or for in vivo regulating of the blood plasma calcium homeostasis.

First claim

The invention claimed is:

1. A method for the therapeutic treatment of hypercalcaemia in an individual, comprising administering to the individual a composition comprising a leucine source and an ω-3 unsaturated fatty acid source providing an ω-3 polyunsaturated fatty acid selected from the group consisting of eicosapentaenoic acid, docosahexaenoic acid, eicosatetraenoic acid and docosapentaenoic acid, wherein the individual is a subject suffering from a cancer, and wherein the composition further includes at least one indigestible oligosaccharide.

2. The method of claim 1 , wherein fatigue is reduced in the individual.

3. The method of claim 1 , wherein the cancer is selected from the group consisting of lung cancer, breast cancer, kidney cancer, multiple myeloma cancer, and head and neck cancer.

4. The method of claim 1 , wherein the composition is used in the treatment of excessive calcium release from bone and/or skeletal muscle; or in the treatment of excessive calcium accumulation due to kidney failure or hyperparathyroidism.

5. The method of claim 1 , wherein the individual is a patient subjected to radiotherapy or chemotherapy.

6. The method of claim 1 , wherein the leucine source comprises at least one compound selected from the group consisting of leucine in the form of a free acid (including its zwitter ionic state), leucine salts, peptides comprising one or more leucine units, proteins comprising one or more leucine units, and conjugates of leucine with a conjugating compound other than an amino acid, a protein, or a peptide, which conjugate is capable of being split into the free amino acid or salt thereof.

7. The method of claim 1 , wherein the leucine source comprises at least 12 wt % of leucine based on total proteinaceous matter.

8. The method of claim 7 , wherein the leucine source comprises at least 15 wt % of leucine based on total proteinaceous matter.

9. The method of claim 8 , wherein the leucine source comprises more than 18 wt % of leucine based on total proteinaceous matter.

10. The method of claim 1 , wherein the at least one indigestable oligosaccharide is an galactooligosaccharide, or fructooligosaccharide.

11. The method of claim 1 , wherein the composition comprises at least 15 g/kg total leucine, based on total weight of proteinaceous matter, fat, carbohydrates plus dietary fibres, of the composition.

12. The method of claim 11 , wherein the composition comprises 30 to 70 g/kg leucine.

13. The method of claim 12 , wherein the composition comprises 40 to 60 g/kg leucine.

14. The method of claim 1 , wherein the composition, has an ω-3 polyunsaturated fatty acid content, based on total lipids, of at least 12 wt %.

15. The method of claim 14 , wherein the composition, has an ω-3 polyunsaturated fatty acid content, based on total lipids, of 18 wt % or more.

16. The method of claim 1 , wherein the composition comprises a marine oil or a fraction thereof, which marine oil or fraction thereof provides at least 70 wt % of the total of ω-3 polyunsaturated fatty acids in the composition.

17. The method of claim 1 , wherein the composition comprises a carbohydrate and is a nutritional composition having a glycemic index of less than 55.

18. The method of claim 1 , wherein the individual is a human.

19. A method for the therapeutic treatment of hypercalcaemia in an individual, comprising administering to the individual a composition comprising a leucine source and an ω-3 unsaturated fatty acid source providing an ω-3 polyunsaturated fatty acid selected from the group consisting of eicosapentaenoic acid, docosahexaenoic acid, eicosatetraenoic acid and docosapentaenoic acid, wherein the individual is a subject suffering from a cancer and, wherein the composition comprises at least 15 g/kg free leucine, based on total weight of proteinaceous matter, fat, carbohydrates plus dietary fibres, of the composition.

20. The method of claim 19 , wherein the composition comprises 22 to 35 g/kg free leucine, based on total weight of proteinaceous matter, fat, carbohydrates plus dietary fibres, of the composition.

21. A method for the prophylactic or therapeutic treatment of hypercalcaemia in an individual comprising administering to the individual a nutritional composition comprising proteinaceous matter, a lipid, and a digestible carbohydrate, wherein
a) the proteinaceous matter content provides 18 to 50 en % of the total composition; the proteinaceous matter providing a leucine source providing at least 15 g/kg leucine, based on total weight of proteinaceous matter, fat, carbohydrates, plus fibers of the composition, a first part of the leucine being in a free form, a second part provided by whey protein,
b) the lipid content provides 10 to 50 en % of the total composition; the lipid comprising and an ω-3 polyunsaturated fatty acid source providing eicosapentaenoic acid and docosahexaenoic acid, wherein the ω-3 polyunsaturated fatty acid content is at least 15 g/kg,
c) the digestible carbohydrate content provides 20 to 70 en %, of the total composition.
d) an indigestible carbohydrate selected from the group of galactooligosaccharides (GOS) and fructooligosaccharides (FOS), the composition having a glycemic index of less than 55.

22. The method of claim 21 , wherein the individual to which the nutritional composition is administered is a patient suffering from a neoplasm.

23. The method of claim 22 , wherein the neoplasm is a lung cancer, breast cancer, kidney cancer, multiple myeloma cancer or head and neck cancer.

24. The method of claim 21 , wherein the individual to which the nutritional composition is administered has hypervitaminosis D.

25. The method of claim 21 , wherein the individual to which the nutritional composition is administered has hyperparathyroidism.

26. The method of claim 21 , wherein the individual to which the nutritional composition is administered has Paget's disease of the bone.

27. The method of claim 21 , wherein the individual to which the nutritional composition is administered has renal failure.

28. The method of claim 21 , wherein the individual to which the nutritional composition is administered is a prolongedly immobilized subject.

29. The method of claim 21 , wherein the individual to which the nutritional composition is administered has aluminium, intoxication, vitamin A intoxication or intoxication with another substance that may result in hypercalcaemia, if not treated.

30. The method of claim 21 , wherein the nutritional composition is administered to provide a long chain ω-3 polyunsaturated fatty acid dosage, of 3.5 g/day-25 g/day and to provide a leucine dosage of 5 g/day to 35 g/day.

31. The method of claim 21 , wherein the individual to which the nutritional composition is administered is a patient suffering from a hematologic malignancy.

Assignees

• Nutricia Nv

Inventors

• Van Norren Klaske
• Faber Joyce
• Van Helvoort Adrianus Lambertus Bertholdus
• Hageman Robert Johan Joseph

Classifications

• A61P7/00

  Drugs for disorders of the blood or the extracellular fluid · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61P39/00

  General protective or antinoxious agents · CPC title

• A61P3/02

  Nutrients, e.g. vitamins, minerals · CPC title

• A61P3/04

  Anorexiants; Antiobesity agents · CPC title