COMPOSITIONS AND METHODS OF TREATING CHRONIC KIDNEY DISEASE

• US 20080317725A1
• Filed: 06/20/2008
• Published: 12/25/2008
• Est. Priority Date: 06/20/2007
• Status: Abandoned Application

• Current Assignee: Seth J. Baum
• Original Assignee: Seth J. Baum
• Inventors: Baum, Seth J.
• Application Number:
  US12/143,022
• Publication Number:
  US 20080317725A1
• Time in Patent Office: Days
• US Class Current: 424/94.1
• CPC Class Codes: A23L 33/11 Plant sterols or derivatives thereof, e.g. phytosterols
• CPC Class Codes: A23L 33/15 Vitamins
• CPC Class Codes: A23L 33/16 Inorganic salts, minerals or trace elements
• CPC Class Codes: A23L 33/185 Vegetable proteins
• CPC Class Codes: A23L 33/19 Dairy proteins
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2200/32 having an effect on the health of the digestive tract
• CPC Class Codes: A23V 2250/026 Alpha lipoic acid, thioctic acid
• CPC Class Codes: A23V 2250/0612 Carnitine
• CPC Class Codes: A23V 2250/0634 N-Acetyl-Cysteine
• CPC Class Codes: A23V 2250/1586 Chromium
• CPC Class Codes: A23V 2250/1626 Selenium
• CPC Class Codes: A23V 2250/1642 Zinc
• CPC Class Codes: A23V 2250/314 Ubiquinone, coenzyme Qn
• CPC Class Codes: A23V 2250/54246 Casein
• CPC Class Codes: A23V 2250/54252 Whey protein
• CPC Class Codes: A23V 2250/5488 Soybean protein
• CPC Class Codes: A23V 2250/702 Vitamin A
• CPC Class Codes: A23V 2250/7042 Vitamin B1
• CPC Class Codes: A23V 2250/7044 Vitamin B2
• CPC Class Codes: A23V 2250/7046 : Vitamin B3 niacin
• CPC Class Codes: A23V 2250/705 : Vitamin B5 pantothenic acid
• CPC Class Codes: A23V 2250/7052 : Vitamin B6
• CPC Class Codes: A23V 2250/7056 : Vitamin B8 Folic acid
• CPC Class Codes: A23V 2250/706 : Vitamin B12
• CPC Class Codes: A23V 2250/7106 : Vitamin D3
• CPC Class Codes: A23V 2250/712 : Vitamin E
• CPC Class Codes: A23V 2250/72 : Biotin
• 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 31/05 : Phenols cannabinoids A61K31/658
• CPC Class Codes: A61K 31/122 : having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
• CPC Class Codes: A61K 31/197 : the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid carnitine A61K31/205
• CPC Class Codes: A61K 31/205 : Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
• CPC Class Codes: A61K 31/221 : with compounds having an amino group, e.g. acetylcholine, acetylcarnitine
• CPC Class Codes: A61K 31/355 : Tocopherols, e.g. vitamin E
• CPC Class Codes: A61K 31/375 : Ascorbic acid, i.e. vitamin C; Salts thereof
• CPC Class Codes: A61K 31/4188 : condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
• CPC Class Codes: A61K 31/4415 : Pyridoxine, i.e. Vitamin B6 pyridoxal phosphate A61K31/675
• CPC Class Codes: A61K 31/455 : Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
• CPC Class Codes: A61K 31/51 : Thiamines, e.g. vitamin B1
• CPC Class Codes: A61K 31/519 : ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 31/525 : Isoalloxazines, e.g. riboflavins, vitamin B2
• CPC Class Codes: A61K 31/575 : substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
• CPC Class Codes: A61K 31/593 : 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
• CPC Class Codes: A61K 31/714 : Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
• CPC Class Codes: A61K 33/04 : Sulfur, selenium or tellurium; Compounds thereof
• CPC Class Codes: A61K 33/24 : Heavy metals; Compounds thereof
• CPC Class Codes: A61K 33/30 : Zinc; Compounds thereof
• CPC Class Codes: A61K 45/06 : Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 13/12 : of the kidneys
• CPC Class Codes: A61P 21/00 : Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 3/02 : Nutrients, e.g. vitamins, minerals

Abstract

The invention relates to nutritional compositions and methods of using these compositions for the treatment of renal disease. More particularly, the invention discloses compositions of vitamins, minerals, amino acids, and/or proteins in amounts that can be used to supplement the nutritional deficiencies observed in patients afflicted with renal disease, renal insufficiency, or end-stage renal disease. The compositions of the invention can also be used as nutritional supplements for patients undergoing dialysis therapy or for patients on a restricted diet. In addition, the compositions can be used in combination or alone as a method of treating or managing a subject in the various stages of chronic renal disease, or throughout disease progression.

Claims

1. A system for the management of renal disease in a subject, the treatment system comprising at least two compositions selected from the group consisting of:

a. a vitamin formulation comprising vitamin C, vitamin D, vitamin E, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin 36, vitamin B12, biotin, vitamin B9, zinc, chromium, and selenium;

b. a composition comprising CoQ10, L-carnitine, lipoic acid, vitamin E, and resveratrol;

c. a composition comprising at least 600 mg of N-acetyl cysteine (NAC) in an enteric coated capsule;

d. a composition comprising phytosterols; and

e. a high protein food bar that has less than about 3 g of sugar per 60 g bar.

2. The treatment system of claim 1, wherein the high protein food bar comprises:

at least about 20 grams of protein per 60 gram high protein food bar;

5-10 % by weight water, 10-30% by weight glycerine, 10-30% by weight manitol syrup, less than about 2% lecithin, 10-30% by weight whey protein, 10-30% by weight calcium caseinate, 5-10% by weight soy protein and less than about 2% wheat germ;

less than about 2 grams of sugar per 60 gram high protein food bar;

less than about 230 mg of sodium; and

less than about 240 mg of potasium.

3. The treatment system of claim 1, wherein the composition comprises about 50 mg of CoQ10 at;

L-carnitine in an amount between about 400 mg and about 500 mg;

about 50 mg of lipoic acid;

about 30 IU of vitamin E; and

resveratrol in an amount between about 50 mg and about 100 mg.

5. The treatment system of claim 1, wherein the composition comprising NAC comprises six enteric coated 600 mg NAC enteric coated capsules and three 500 mg vitamin C capsule in a blister package arranged as a three by three matrix, wherein a first column is marked as being a first dayly dosage, a second column is marked as being a second dayly dosage and a third column is marked as being a third dayly dosage and each column contains three capsules organized as a first NAC enteric coated capsule, a vitamin C capsule and a second NAC enteric coated capsule.

4. The treatment system of claim I, wherein the vitamin formulation comprises at least about 500% of the RDV of vitamin B₆, at least about 16,000% of the RDV of vitamin B₁₂, and at least about 1,000% of the RDV of vitamin B₉.

6. A high protein food bar comprising:

at least about 20 grams of protein per 60 grain high protein food bar;

a PDCAAS score of about 1; and

5-10% by weight water, 10-30% by weight glycerine, 10-30% by weight polyol as a sweetener, less than about 2% lecithin, 10-30% by weight whey protein, 10-30% by weight calcium caseinate, 5-10% by weight soy protein and less than about 2% wheat germ.

7. The high protein food bar of claim 6, having less than 2 grains of sugar per 60 gram high protein food bar.

8. The high protein food bar of claim 6, having less than about 230 mg of sodium.

9. The high protein food bar of claim 6, having less than about 240 mg of potassium.

10. The high protein food bar of claim 6, having 1 gram of sugar.

11. The high protein food bar of claim 6, comprising less than about 20% of the Recommended Daily Value of phosphorous.

12. The high protein food bar of claim 6, wherein the food bar is contained in a wrapper label that states the food bar is intended to be used to manage protein needs for a patient undergoing dialysis or a patient suffering from diabetes.

13. The high protein food bar of claim 6, wherein the food bar comprises an outer layer made with maltitol powder, palm kernel oil, non fat milk solids, cocoa powder, soya lecithin, salt and natural flavor.

14. The high protein food bar of claim 6, wherein no chicory syrup, cane sugar, caramel, fructose, sucrose, corn syrup, or beet sugar is added to the high protein food bar.

15. A method of treating skeletal muscle wasting in a subject, the method comprising:

providing a subject with a protein source formulated for the management of the nutrient needs that result from kidney disease;

administering the protein source comprising at least about 20 grams of protein per 60 gram high protein food bar having a PDCAAS score of about 1, about 1 gram of sugar, less than about 230 mg of sodium and less than about 240 mg of potassium;

wherein the high protein food bar is sweetened with a polyol and is free of added vitamins to the subject, thereby compensating for protein depleation in the subject.

16. The method according to claim 15, wherein the high protein food bar does not contain a substance regulated by the United States Food and Drug Administration.

17. The method according to claim 15, wherein the high protein food bar is sweetened with a polyol.

18. The method according to claim 17, wherein the polyol is maltitol.

19. A composition comprising Vitamin E, Alpha lipoic acid, L-Carnitine, Coenzyme Q10, and Resveratrol.

20. The composition of claim 19, wherein the composition is contained in a capsule.

21. The composition of claim 20, comprising 30 internation units of Vitamin E, about 50 mg of alpha lipoic acid, about 400 mg of L-Carnitine, about 50 mg of Coenzyme Q10, and about 50 mg of resveratrol.

22. A method for treating or preventing weakness, fatigue or cramping associated with kidney disease, the method comprising administering a composition comprising Vitamin E, Alpha lipoic acid, L-Carnitine, Coenzyme Q10, and Resveratrol, to a subject suffering from weakness, fatique or cramping associated with kidney disease.

23. A vitamin formulation comprising:

a capsule comprising vitamin C, vitamin D₃, vitamin E, vitamin B₁, vitamin B₂, vitamin B₃, vitamin B₅, vitamin B₆, vitamin B₁₂, biotin, vitamin B₉, copper, zinc, chromium, and selenium, wherein the vitamin B₁₂ is present in an amount of at least 16,667% ofthe RDV per capsule.

24. The vitamin formulation of claim 23, wherein the vitamin B₉ is present in an amount of at least about 750% of the RDV.

25. The vitamin formulation of claim 24, wherein composition provides about 200% of the Recommended Daily Value (RDV) of vitamin B₅, about 1,250% of the RDV of vitamin B₆, about 33,333% of the RDV of vitamin B₁₂, and about 1,250% of the RDV of vitamin B₉.

26. The vitamin formulation of claim 24, wherein the composition comprises 100% of the Recommended Daily Value (RDV) of vitamin B₅, about 500% of the RDV of vitamin 36, about 16,667% of the RDV of vitamin B₁₂, and about 750% of the RDV of vitamin B₉.

27. A method of managing a subject diagnosed with chronic renal disease, comprising administering a capsule comprising vitamin C, vitamin D₃, vitamin E, vitamin B₁, vitamin B₂, vitamin B₃, vitamin B₅, vitamin B₆, vitamin B₁₂, biotin, vitamin B₉, copper, zinc, chromium, and selenium, wherein the vitamin B₁₂ is present in an amount of at least 16,667% of the RDV per capsule and wherein the formulation of the composition changes at least once as the subject'"'"'s disease state changes.

28. The method according to claim 27, further comprising administering a second composition comprising CoQ10, L-carnitine, lipoic acid, vitamin E and resveratrol, to a subject suffering from weakness, fatique or cramping associated with kidney disease.

29. The method according to claim 28, wherein the composition comprises administering an enteric coated capsule providing about 200% of the Recommended Daily Value (RDV) of vitamin B₅, about 1,250% of the RDV of vitamin B₆, at least about 33,000% of the RDV of vitamin B₁₂, and about 1,250% of the RoV of vitamin B₉.

30. The method according to claim 27, wherein the composition comprises administering an enteric coated capsule providing 100% of the Recommended Daily Value (RDV) of vitamin B₅, about 500% of the RDV of vitamin B₆, at least about 16,000% of the RDV of vitamin B₁₂, and about 750% of the RDV of vitamin B₉.