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Title:
EDIBLE SOLIDS FOR TREATMENT OF GLUCOSE METABOLISM DISORDERS
Document Type and Number:
WIPO Patent Application WO/2000/057721
Kind Code:
A2
Abstract:
Compositions and methods of using the same for the treatment of diabetes and other disorders of glucose metabolism are provided. Compositions may include one or more of a bioavailable source of chromium and vanadium, and may be formulated as edible solids.

Inventors:
MENDLEIN JOHN D (US)
THOMPSON JANICE E (US)
FINE STUART A (US)
KINSELLA KEVIN J (US)
Application Number:
PCT/US2000/008013
Publication Date:
October 05, 2000
Filing Date:
March 24, 2000
Export Citation:
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Assignee:
AKESIS PHARM INC (US)
MENDLEIN JOHN D (US)
THOMPSON JANICE E (US)
FINE STUART A (US)
KINSELLA KEVIN J (US)
International Classes:
A61K33/24; A23L1/304; A23L2/39; A23L2/52; A23L7/10; A23L33/15; A61K45/06; (IPC1-7): A23L1/00
Domestic Patent References:
WO1998004248A11998-02-05
Foreign References:
DE29805782U11998-07-30
EP0834318A11998-04-08
US5013752A1991-05-07
US5614224A1997-03-25
Attorney, Agent or Firm:
Taft, Kingsley L. (Hoag & Eliot LLP One Post Office Square Boston, MA, US)
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Claims:
What is claimed is:
1. An edible solid in a continuous mass form, comprising a solid caloric source of at least about 25 kilocalories and one or more of the following: a bioavailable form of chromium to provide for at least about 100 mcg of chromium, and a bioavailable form of vanadium to provide for at least about 5 mg of vanadium.
2. The edible solid of claim 1, wherein a ratio of said chromium to said solid caloric source is about 100 mcg or more of chromium per 100 kilocalories of said solid caloric source.
3. The edible solid of claim 1, wherein said solid edible solid is a continuous mass between about 20 and about 150 grams.
4. The edible solid of claim 3, further comprising a flavoring agent.
5. The edible solid of claim 1, further comprising one or more of the following: a bioavailable form of magnesium that delivers at least about 300 mg of magnesium, a form of vitamin E that delivers at least about 300 I. U. of vitamin E, and a form of aspirin that delivers at least about 20 mg of aspirin.
6. The edible solid of claim 1, further comprising a therapeutically effective amount of an antidiabetic agent, wherein said antidiabetic agent is selected from the group consisting of thiazolidinediones, sulfonylureas, benzoic acid derivatives and alphaglucosidase inhibitors.
7. The edible solid of claim 1, wherein a ratio of said vanadium to said solid caloric source is about 10 mg or more of vanadium per 100 kilocalories of said caloric source.
8. The edible solid of claim 1, wherein said solid caloric source comprises a complex carbohydrate.
9. The edible solid of claim 1, wherein said solid caloric source comprises fructose or glucose.
10. The edible solid of claim 1, wherein said bioavailable form of chromium comprises an organic 5 or 6 member ring having at least one carboxylic acid substituent.
11. The edible solid of claim 1, wherein said bioavailable form of chromium is chromium polynicotinate and said bioavailable form of vanadium comprises vanadyl.
12. The edible solid of claim 1, wherein said solid caloric source comprises a source of protein.
13. The edible solid of claim 1, further comprising at least about 100% of the RDA for a vitamin in said edible solid, and at least about 100% of the RDA for a mineral in said edible solid.
14. The edible solid of claim 1, further comprising a source of chocolate.
15. The edible solid of claim 1, further comprising a source of fruit.
16. The edible solid of claim 1, further comprising a source of peanut.
17. The edible solid of claim 1, wherein said bioavailable form of vanadium provides at least about 15 mg of vanadium.
18. The edible solid of claim 1, wherein said bioavailable form of vanadium provides at least about 25 mg of vanadium.
19. The edible solid of claim 1, wherein said bioavailable form of vanadium provides at least about 50 mg of vanadium.
20. The edible solid of claim 1, wherein said bioavailable form of vanadium provides at least about 75 mg of vanadium.
21. The edible solid of claim 1, wherein said bioavailable form of chromium provides at least about 250 mg of chromium.
22. The edible solid of claim 1, wherein said bioavailable form of chromium provides at least about 350 mg of chromium.
23. The edible solid of claim 1, wherein said bioavailable form of chromium provides at least about 500 mg of chromium.
24. The edible solid of claim 21, wherein said bioavailable form of vanadium provides at least about 25 mg of vanadium.
25. The edible solid of claim 21, wherein said bioavailable form of vanadium provides at least about 50 mg of vanadium.
26. The edible solid of claim 21, wherein said bioavailable form of vanadium provides at least about 75 mg of vanadium.
27. The edible solid of claim 23, wherein said bioavailable form of vanadium provides at least about 25 mg of vanadium.
28. The edible solid of claim 23, wherein said bioavailable form of vanadium provides at least about 50 mg of vanadium.
29. The edible solid of claim 23, wherein said bioavailable form of vanadium provides at least about 75 mg of vanadium.
30. The edible solid of claim 18, wherein said bioavailable form of chromium is chromium polynicotinate and said bioavailable form of vanadium comprises vanadyl.
31. The edible solid of claim 18, wherein said bioavailable form of chromium is chromium polynicotinate and said bioavailable form of vanadium comprises vanadyl.
32. The edible solid of claim 21, wherein said bioavailable form of chromium comprises chromium picolinate and said bioavailable form of vanadium comprises vanadyl sulfate.
33. The edible solid of claim 27, wherein said bioavailable form of chromium comprises an organic 5 or 6 member ring having at least one carboxylic acid substituent, and said bioavailable form of vanadium comprises vanadyl.
34. A kit for alleviating and treating glucose metabolism disorders, comprising an edible solid in a continuous mass form, comprising: (a) a solid caloric source of at least about 25 kilocalories; (b) one or more of the following: a therapeutically effective amount of a bioavailable form of chromium, and a therapeutically effective amount of a bioavailable form of vanadium; and (c) instructions for a patient to consume said edible solid about at least once a day for at least about thirty days to alleviate and treat glucose metabolism disorders.
35. A finished nutritional solid food product for consumption and treating or delaying the onset of diabetic symptoms, comprising a chewable, solid caloric source in at least one single mass greater than about 25 grams and a therapeutically effective amount of an agent that combats diabetes or onset of diabetes, wherein said agent is an antidiabetic agent selected from the group consisting of thiazolidinediones, sulfonylureas, benzoic acid derivatives and alphaglucosidase inhibitors.
36. The finished nutritional solid food product of claim 35, wherein said antidiabetic agent is metformin.
37. The finished nutritional solid food product of claim 36, wherein the dose of metformin is in the range of about 100 mg up to about 2550 mg per nutritional solid food product.
38. The finished nutritional solid food product of claim 35, wherein said antidiabetic agent is a sulfonylurea.
39. The finished nutritional solid food product of claim 38, wherein said sulfonylurea is acetohexamide, chlorpropamide, tolazimide, tolbutamide, glycazide, glipizide, glyburide, or glimeperide.
40. The finished nutritional solid food product of claim 35, wherein said antidiabetic agent is a thiazolidinedione.
41. The finished nutritional solid food product of claim 40, wherein said thiazolidinedione is troglitazone.
42. The finished nutritional solid food product of claim 35, wherein said antidiabetic agent is an alphaglucosidase inhibitor.
43. The finished nutritional solid food product of claim 42, wherein said alpha glucosidase inhibitor is acarbose or miglitol.
44. The finished nutritional solid food product of claim 35, wherein said antidiabetic agent is a benzoic acid derivative.
45. The finished nutritional solid food product of claim 44, wherein said antidiabetic agent is repaglinide.
46. A finished nutritional solid food product for consumption and treating or delaying the onset of diabetic symptoms, comprising (a) a chewable, solid caloric source in at least one single mass greater than about 25 grams; (b) a therapeutically effective amount of an agent that combats diabetes or onset of diabetes, wherein said agent is one or more of the following: a bioavailable form of chromium in an amount that delivers at least about 150 mcg of chromium and a bioavailable form of vanadium; and (c) a second agent that is one or more of the following: vitamin E, aspirin, a bioavailable form of magnesium and lipoic acid.
47. The finished nutritional solid food product of claim 46, further comprising a therapeutically effective amount of an antidiabetic agent, wherein said antidiabetic agent is selected from the group consisting of thiazolidinediones, sulfonylureas, benzoic acid derivatives and alphaglucosidase inhibitors.
48. The finished nutritional solid food product of claim 46, wherein said agent comprises a bioavailable form of chromium with a dosage of at least about 250 mcg of chromium.
49. The finished nutritional solid food product of claim 48, wherein said second agent comprises a bioavailable form of magnesium with a dosage of at least about 40 mg of magnesium.
50. The finished nutritional solid food product of claim 46, wherein said agent comprises a bioavailable form of chromium with a dosage of at least about 500 mcg of chromium.
51. The finished nutritional solid food product of claim 50, wherein said second agent comprises a bioavailable form of magnesium with a dosage of at least about 25 mg of magnesium.
52. The finished nutritional solid food product of claim 46, wherein said agent comprises a bioavailable form of chromium with a dosage of at least about 900 mcg of chromium.
53. The finished nutritional solid food product of claim 46, wherein said agent comprises a bioavailable form of vanadium with a dosage of at least about 12 mg of vanadium.
54. The finished nutritional solid food product of claim 46, wherein said agent comprises a bioavailable form of vanadium with a dosage of at least about 22 mg of vanadium.
55. The finished nutritional solid food product of claim 46, wherein said agent comprises a bioavailable form of vanadium with a dosage of at least about 55 mg of vanadium.
56. The finished nutritional solid food product of claim 54, wherein said second agent comprises a bioavailable form of magnesium with a dosage of at least about 40 mg of magnesium.
57. The finished nutritional solid food product of claim 54, wherein said second agent is vitamin E with a dosage of at least about 150% of the RDA.
58. The finished nutritional solid food product of claim 54, wherein said second agent is aspirin with a dosage of at least about 40 mg.
59. The finished nutritional solid food product of claim 54, further comprising a bioavailable form of chromium with a dosage of at least about 150 mcg of chromium.
60. The finished nutritional solid food product of claim 55, further comprising a bioavailable form of chromium with a dosage of at least about 150 mcg of chromium.
61. The finished nutritional solid food product of claim 53, further comprising a bioavailable form of chromium with a dosage of at least about 250 mcg of chromium.
62. The finished nutritional solid food product of claim 53, further comprising a bioavailable form of chromium with a dosage of at least about 500 mcg of chromium.
63. The finished nutritional solid food product of claim 59, wherein said second agent is aspirin with a dosage of at least about 40 mg.
64. The finished nutritional solid food product of claim 59, wherein said second agent is a bioavailable form of magnesium with a dosage of at least about 40 mg.
65. The finished nutritional solid food product of claim 59, wherein said second agent is vitamin E with a dosage of at least about 150% of the RDA.
66. A cereal product, comprising: a cereal product having a caloric content of at least about 25 kilocalories, and one or more of the following: a bioavailable form of chromium to provide for at least about 15 mcg of chromium per about 100 kilocalories of said cereal product, and a bioavailable form of vanadium to provide for at least about 1 mg of vanadium per about 100 kilocalories of said cereal product.
67. The cereal product of claim 66, wherein said bioavailable form of chromium provides for at least about 15 mcg of chromium per about 75 kilocalories of said cereal product, and said bioavailable form of vanadium provides for at least about 1 mg of vanadium per about 75 kilocalories of said cereal product.
68. The cereal product of claim 66, wherein said bioavailable form of chromium provides for at least about 15 mcg of chromium per about 60 kilocalories of said cereal product, and said bioavailable form of vanadium provides for at least about 1 mg of vanadium per about 60 kilocalories of said cereal product.
69. The cereal product of claim 66, wherein said bioavailable form of chromium provides for at least about 15 mcg of chromium per about 40 kilocalories of said cereal product, and said bioavailable form of vanadium provides for at least about 1 mg of vanadium per about 40 kilocalories of said cereal product.
70. The cereal product of claim 66, wherein said bioavailable form of chromium provides for at least about 15 mcg of chromium per about 25 kilocalories of said cereal product, and said bioavailable form of vanadium provides for at least about 1 mg of vanadium per about 25 kilocalories of said cereal product.
71. The cereal product of claim 66, wherein said bioavailable form of chromium provides for at least about 15 mcg of chromium per about 15 kilocalories of said cereal product, and said bioavailable form of vanadium provides for at least about 1 mg of vanadium per about 15 kilocalories of said cereal product.
72. The cereal product of claim 66, wherein said bioavailable form of chromium provides for at least about 30 mcg of chromium per about 15 kilocalories of said cereal product, and said bioavailable form of vanadium provides for at least about 2 mg of vanadium per about 15 kilocalories of said cereal product.
73. The cereal product of claim 66, wherein said cereal product has a good mouth feel, texture and flavor characteristics.
74. The cereal product of claim 66, wherein said cereal product is ready to eat.
75. The cereal product of claim 66, further comprising a liquid.
76. The cereal product of claim 66, wherein said liquid is milk.
77. The cereal product of claim 66, further comprising one or more of the following: a bioavailable form of magnesium that delivers at least about 25 mg of magnesium per about 100 kilocalories of said cereal product, a form of vitamin E that delivers at least about 50 I. U. of vitamin E per about 100 kilocalories of said cereal product, and a form of aspirin that delivers at least about 3 mg of aspirin per about 100 kilocalories of said cereal product.
78. The cereal product of claim 66, wherein said cereal product comprises a plurality of pieces.
79. The cereal product of claim 78, wherein said pieces are in the one of the following shapes: flakes, squares, circles, biscuits, ring.
80. The cereal product of claim 78, wherein one or more of said pieces may be ingested in a single mouthful by an adult human.
81. The cereal product of claim 66, wherein said cereal product has at least about 3 of said pieces per about 100 kilocalories of said cereal product.
82. The cereal product of claim 66, wherein said cereal product has at least about 5 of said pieces per about 100 kilocalories of said cereal product.
83. The cereal product of claim 66, wherein said cereal product has at least about 10 of said pieces per about 100 kilocalories of said cereal product.
84. The cereal product of claim 66, wherein said cereal product has at least about 25 of said pieces per about 100 kilocalories of said cereal product.
85. The cereal product of claim 66, wherein said bioavailable form of chromium comprises an organic 5 or 6 member ring having at least one carboxylic acid substituent..
86. The cereal product of claim 66, wherein said bioavailable form of vanadium comprises vanadyl.
87. The cereal product of claim 66, wherein said caloric content comprises a source of fiber.
88. The cereal product of claim 66, further comprising at least about 25% of the RDA for a vitamin per about 75 kilocalories of said cereal product, and at least about 25% of the RDA for a mineral per about 75 kilocalories of said cereal product.
89. The cereal product of claim 66, wherein said cereal product comprises a bioavailable form of chromium, wherein said bioavailable form of chromium provides for at least about 15 mcg of chromium per about 100 kilocalories of said cereal product, and wherein said cereal product furthers comprises a bioavailable form of vanadium, wherein said bioavailable form of vanadium provides for at least about 1 mg of vanadium per about 100 kilocalories of said cereal product.
90. The cereal product of claim 66, wherein said cereal product comprises a bioavailable form of chromium, wherein said bioavailable form of chromium provides for at least about 15 mcg of chromium per about 100 kilocalories of said cereal product, and wherein said cereal product furthers comprises a bioavailable form of vanadium, wherein said bioavailable form of vanadium provides for at least about 1 mg of vanadium per about 100 kilocalories of said cereal product.
91. The cereal product of claim 66, wherein said cereal product comprises a bioavailable form of chromium, wherein said bioavailable form of chromium provides for at least about 15 mcg of chromium per about 100 kilocalories of said cereal product, and wherein said cereal product furthers comprises a bioavailable form of vanadium, wherein said bioavailable form of vanadium provides for at least about 1 mg of vanadium per about 50 kilocalories of said cereal product.
92. The cereal product of claim 66, wherein said cereal product comprises a bioavailable form of chromium, wherein said bioavailable form of chromium provides for at least about 15 mcg of chromium per about 100 kilocalories of said cereal product, and wherein said cereal product furthers comprises a bioavailable form of vanadium, wherein said bioavailable form of vanadium provides for at least about 1 mg of vanadium per about 25 kilocalories of said cereal product.
93. The cereal product of claim 66, wherein said cereal product comprises a bioavailable form of chromium, wherein said bioavailable form of chromium provides for at least about 15 mcg of chromium per about 25 kilocalories of said cereal product, and wherein said cereal product furthers comprises a bioavailable form of vanadium, wherein said bioavailable form of vanadium provides for at least about 1 mg of vanadium per about 40 kilocalories of said cereal product.
94. A method of treating glucose metabolism disorders, comprising: administrating to a subject in need thereof an edible solid comprising: (a) a digestible caloric source of at least about 25 kilocalories; (b) a therapeutically effective amount of a bioavailable form of chromium; and (c) a therapeutically effective amount of a bioavailable form of vanadium.
95. The method of claim 94, wherein said edible solid is a cereal product comprised of a plurality of pieces.
96. A method of treating glucose metabolism disorders, comprising: administrating to a subject in need thereof an edible solid comprising: (a) a digestible caloric source of at least about 25 kilocalories; (b) a therapeutically effective amount of a bioavailable form of chromium; and (c) and a therapeutically effective amount of a bioavailable form of magnesium, wherein said amount of chromium is at least about 250 mcg and wherein said amount of magnesium is at least about 40 mg.
97. A method of treating a subject with elevated HbAlc levels, comprising: monitoring HbAlc levels and administrating to a subject in need thereof a chewable, solid matrix comprising: (a) a caloric source of at least about 10 kilocalories; and (b) one or more of the following: a bioavailable form of chromium, wherein said bioavailable form of chromium delivers a therapeutically effective amount of chromium, and a bioavailable form of vanadium, wherein said bioavailable form of vanadium delivers a therapeutically effective amount of vanadium.
98. The method of claim 97, wherein said solid matrix comprises a bioavailable form of chromium, wherein said bioavailable form of chromium delivers a therapeutically effective amount of chromium, and wherein said solid matrix further comprises a bioavailable form of vanadium, wherein said bioavailable form of vanadium delivers a therapeutically effective amount of vanadium.
99. The method of claim 97, wherein said solid matrix further comprises a bioavailable form of magnesium, wherein said bioavailable form of magnesium delivers a therapeutically effective amount of magnesium.
100. The use of a finished nutritional solid food product for the manufacture of a medicament for consumption and treating or delaying the onset of diabetic symptoms in a subject, wherein said finished nutritional solid food product comprises: (a) a chewable, solid caloric source in at least one single mass greater than about 25 grams; (b) a therapeutically effective amount of an agent that combats diabetes or onset of diabetes, wherein said agent is one or more of the following: a bioavailable form of chromium in an amount that delivers at least about 150 mcg of chromium and a bioavailable form of vanadium, and (c) a second agent that is one or more of the following: vitamin E, aspirin, a bioavailable form of magnesium and lipoic acid.
101. The use of an edible solid for the manufacture of a medicament for the treatment of glucose metabolism disorders in a subject, wherein said edible solid comprises: (a) a caloric source of at least about 25 kilocalories; and (b) one or more of the following: a bioavailable form of chromium to provide for at least about 100 mcg of chromium and a bioavailable form of vanadium to provide for at least about 5 mg of vanadium.
102. The use of claim 101, wherein said edible solid is a cereal product comprised of a plurality of pieces.
103. The use of a solid matrix food for the manufacture of a medicament for consumption and treating or delaying the onset of diabetic symptoms in a subject, wherein said finished solid matrix food product comprises (a) a chewable caloric source in at least one single mass greater than about 25 grams; and (b) a therapeutically effective amount of an agent that combats diabetes or onset of diabetes, wherein said agent is an antidiabetic agent selected from the group consisting of thiazolidinediones, sulfonylureas, benzoic acid derivatives and alphaglucosidase inhibitors.
Description:
INTERNATIONAL SEARCH REPORT Interna&'nal Application No PCT/iS 00/08013 C. (Continuation) DOCUMENTS CONSIDERED TO BE RELEVANT Category Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No. X US 5 013 752 A (DOBBINS) 1-5, 7 May 1991 (1991-05-07) 8-13,15, 21,34, 46,48, 49, 100-102 column 5, line 43-column 6, line 32; claims X US 5 614 224 A (WOMACK) 1-35, 25 March 1997 (1997-03-25) 46-102 column 6, line 26-line 37; claims; table 1 1 Ir, ational application No. INTERNATIONAL SEARCH REPORT PCT/US 00/08013 Box I Observations where certain claims were found unsearchable (Continuation of item 1 of first sheet) This International Search Report has not been established in respect of certain claims under Article 17 (2) (a) for the following reasons: 1. nj Claims Nos.: because they relate to subject matter not required to be searched by this Authority, namely: 2. Claims Nos.: because they relate to parts of the International Application that do not comply with the prescribed requirements to such an extent that no meaningful International Search can be carried out, specifically : 3. gj Claims Nos. : because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4 (a). Boxai Observations where unity of invention is lacking (Continuation of item 2 of first sheet) This International Searching Authority found multiple inventions in this international application, as follows: 1. As all required additional search fees were timely paid by the applicant, this International Search Report covers all searchable claims. 2. nj As all searchable claims could be searched without effort justifying an additional fee, this Authority did not invite payment of any additional fee. 3. As only some of the required additional search fees were timely paid by the applicant, this International Search Report covers only those claims for which fees were paid, specifically claims Nos.: 4. gj No required additional search fees were timely paid by the applicant. Consequently, this International Search Report is restricted to the invention first mentioned in the claims; it is covered by claims Nos.: 1-34,46-65,66-96,97-102 (partially) Remark on Protest The additional search fees were accompanied by the applicant's protest. No protest accompanied the payment of additional search fees. u International Application No. PCT/US 00/08013 FURTHER INFORMATION CONTINUED FROM PCT/ISA/210 1. Claims: 1-34 (partially), 46-65 (partially), 66-96, 97-102 (partially) Edible solid composition comprising a solid caloric source of at least 25 kilocalories, a bioavailable form of chromium to provide for at least 100 mcg of chromium, possibly in combination with vanadium to provide for at least 5 mg of vanadium. A cereal product comprising a bioavailable form of chromium to provide for at least 15 mcg of chromium, possibly in combination with vanadium to provide for at least 1 mg of vanadium. 2. Claims: 35-45,103 A composition comprising a chewable solid caloric source and a therapeutically effective amount of an anti-diabetic agent selected from the group of thiazolinediones, sulfonylureas, benzoic acid derivatives and alpha-glucosidase inhibitors. 3. Claims: 1-34 (partially), 46-65 (partially), 97-102 (partially) Edible solid composition comprising a solid caloric source of at least 25 kilocalories, a bioavailable form of vanadium. INTERNATIONAL SEARCH REPORT intern'nazi Application No rmation on patent family members PCT/JS 00/08013 Patent document Publication Patent family Publication cited in search report date member (s) date DE 29805782 U 30-07-1998 CZ 9701012 A 14-10-1998 IT MI980695 A 05-10-1998 EP 834318 A 08-04-1998 DE 19640602 C 04-06-1998 WO 9804248 A 05-02-1998 US 5654011 A 05-08-1997 US 5807586 A 15-09-1998 US 6040333 A 21-03-2000 AU 718218 B 13-04-2000 AU 3958797 A 20-02-1998 CA 2261764 A 05-02-1998 EP 0934060 A 11-08-1999 US 5013752 A 07-05-1991 US 4918102 A 17-04-1990 US 5614224 A 25-03-1997 US 5730988 A 24-03-1998