U.S. patent application number 11/710893 was filed with the patent office on 2008-08-28 for composition to provide maintenance and nutritional support in glycemic control deficits.
This patent application is currently assigned to NBTY, Inc.. Invention is credited to Schneider Glenn, Silverman Robert, Angelica Vrablic.
Application Number | 20080207717 11/710893 |
Document ID | / |
Family ID | 39711214 |
Filed Date | 2008-08-28 |
United States Patent
Application |
20080207717 |
Kind Code |
A1 |
Vrablic; Angelica ; et
al. |
August 28, 2008 |
Composition to provide maintenance and nutritional support in
glycemic control deficits
Abstract
A Composition to provide nutritional support for mammals having
glycemic control and deficit concerns, and assist in managing
glycemic controls deficits, with a synergistic combination of
natural ingredients.
Inventors: |
Vrablic; Angelica; (Boca
Raton, FL) ; Glenn; Schneider; (Bohemia, NY) ;
Robert; Silverman; (Bohemia, NY) |
Correspondence
Address: |
NBTY, Inc. - Lee Grosskreuz Hechtel, Esq,
90 Orville Drive
Bohemia
NY
11716-2510
US
|
Assignee: |
NBTY, Inc.
Bohemia
NY
|
Family ID: |
39711214 |
Appl. No.: |
11/710893 |
Filed: |
February 26, 2007 |
Current U.S.
Class: |
514/393 |
Current CPC
Class: |
A61K 36/54 20130101;
A61K 36/33 20130101; A61P 3/10 20180101; A61K 2300/00 20130101;
A61K 2300/00 20130101; A61K 36/33 20130101; A61K 36/54
20130101 |
Class at
Publication: |
514/393 |
International
Class: |
A61K 31/415 20060101
A61K031/415; A61P 3/10 20060101 A61P003/10 |
Claims
1. (canceled)
2. (canceled)
3. (canceled)
4. (canceled)
5. (canceled)
6. (canceled)
7. (canceled)
8. (canceled)
9. (canceled)
10. (canceled)
11. (canceled)
12. (canceled)
13. (canceled)
14. (canceled)
15. A dietary supplement Composition of botanically-derived
ingredients, consisting of: nopal, cinnamon, chlorogenic acid,
biotin, and pantothenic acid.
16. (canceled)
17. The dietary supplement Composition of botanically-derived
ingredients of claim 16, wherein the dietary supplement Composition
is formed into a capsule.
18. The dietary supplement Composition of botanically-derived
ingredients of claim 17, wherein the amount of nopal in a dosage is
in the range of 1 gram to 5 grams 200 mg to 100 mg.
19. The dietary supplement Composition of botanically-derived
ingredients of claim 18 wherein the amount of cinnamon in a dosage
is in the range of 100 milligrams to 1 gram.
20. The dietary supplement Composition of botanically-derived
ingredients of claim 19, wherein the amount of chlorogenic acid in
a dosage is in the range of 50 milligrams to 300 milligrams.
21. The dietary supplement Composition of botanically-derived
ingredients of claim 20, wherein the amount of biotin in a dosage
is in the range of 50 micrograms to 200 micrograms.
22. The dietary supplement Composition of botanically-derived
ingredients of claim 21, wherein the amount of pantothenic acid in
a dosage is in the range of 1 milligram to 50 milligrams.
23. (canceled)
24. (canceled)
25. (canceled)
26. (canceled)
27. (canceled)
28. (canceled)
29. (canceled)
30. (canceled)
31. (canceled)
32. (canceled)
33. (canceled)
34. (canceled)
35. (canceled)
36. (canceled)
37. (canceled)
38. (canceled)
39. (canceled)
40. (canceled)
41. (canceled)
42. (canceled)
43. (canceled)
44. (canceled)
45. (canceled)
46. (canceled)
47. The dietary supplement Composition of botanically-derived
ingredients of claim 18, wherein the amount of nopal in a dosage is
in the range of 300 milligrams to 500 milligrams.
48. The dietary supplement Composition of botanically-derived
ingredients of claim 18, wherein the amount of nopal in a dosage is
in the range of 200 milligrams to 400 milligrams.
49. The dietary supplement Composition of botanically-derived
ingredients of claim 19, wherein the amount of cinnamon in a dosage
is in the range of 50 milligrams to 150 milligrams.
50. The dietary supplement Composition of botanically-derived
ingredients of claim 49, wherein the amount of cinnamon in a dosage
is in the range of 25 milligrams to 75 milligrams.
51. The dietary supplement Composition of botanically-derived
ingredients of claim 20, wherein the amount of chlorogenic acid in
a dosage is in the range of 25 milligrams to 50 milligrams.
52. The dietary supplement Composition of botanically-derived
ingredients of claim 51, wherein the amount of chlorogenic acid in
a dosage is in the range of 15 milligrams to 20 milligrams.
53. The dietary supplement Composition of botanically-derived
ingredients of claim 21, wherein the amount of biotin in a dosage
is in the range of 25 micrograms to 75 micrograms.
54. The dietary supplement Composition of botanically-derived
ingredients of claim 22, wherein the amount of pantothenic acid in
a dosage is in the range of 1 milligram to 4 milligrams.
Description
FIELD OF THE INVENTION
[0001] A composition useful for managing and providing nutritional
support for glycemic balance and control deficits in animals, and
particularly, in mammals, including humans.
BACKGROUND
[0002] Diabetes, metabolic syndrome, impaired glucose tolerance and
related problems in glycemic control and management are tremendous
public health concerns which affect millions of people in the
United States and worldwide.
[0003] Diabetes is believed to have multiple etiologies including,
inter alia, genetics, diet, exercise, sleep, caloric intake,
trauma, infection, stress, drug use, and/or autoimmune reactions.
Diabetes is generally classified into two general categories, where
diabetes mellitus is typically known as type I diabetes due to
insulin deficiency. Insulin is responsible for the regulation of a
variety of metabolic functions, including the conversion of glucose
to glycogen to lower the blood glucose level. Other forms of
diabetes that can occur due to reduced insulin effectiveness in
conjunction with other primary diseases are generally known as type
11 diabetes. Furthermore, diabetes is a chronic disease having a
variety of pathological manifestations, and may be accompanied by
disorders of lipid metabolism, circulation and glucose metabolism,
among other effects.
[0004] In addition, aging may also cause a progressive loss of
glucose tolerance possibly based on decreased insulin sensitivity
in hypothalamic receptors and/or decreased response to glucose and
insulin in the peripheral tissue. Should a glucose tolerance loss
become pronounced, the condition would be diagnosed and treated as
diabetes would be.
[0005] It would be highly advantageous to provide a composition
that assists in managing glycemic control and levels with
nutritional support beneficial for those affected by such
deficits.
SUMMARY
[0006] A Composition of botanically-derived ingredients,
naturally-occurring ingredients, including nopal, cinnamon,
chlorogenic acid, biotin, and pantothenic acid, and extracts
thereof, which may be formed into a dietary supplement product. The
Composition may be used to provide nutritional support for mammals
inflicted with glycemic level concerns and assist in managing
glycemic control problems such as, for example, diabetes, metabolic
syndrome, impaired glucose tolerance, and related glycemic deficits
and problems.
DETAILED DESCRIPTION
[0007] This disclosure relates to a dietary supplement Composition
for supporting positive health and bodily nutrition, and managing
deficits in glycemic levels, or blood glucose (sugar) levels, in
mammals. Deficits in glycemic control may include, for example,
diabetes, metabolic syndrome, and related disorders or problems
associated with glycemic control. This Composition includes a
combination of naturally-occurring, botanically-derived
ingredients, such as natural compounds and extracts having
hypoglycemic properties, and vitamin components, which combine to
produce synergistic and complementary beneficial effects in
mammals. This Composition may also alleviate the various symptoms
associated with glycemic deficits, by supporting and improving the
general bodily health of a mammal suffering with such concerns.
[0008] The Composition is a synergistic combination of nopal, a
species of Opuntia, also known as prickly pear cactus; cinnamon or
cinnamon extract (Cinnamomum cassia); chlorogenic acid which is
typically found in green coffee beans and berries; biotin; and
pantothenic acid, each of which separately is known to positively
affect glycemic control, and in combination provides additional
positive synergistic effects.
[0009] Nopal, particularly the cactus petal portion of the plant,
is widely used as a food in the Southwestern United States, Mexico,
and other areas. It is also used as a folk remedy for glucose
control in those areas. Nopal has high soluble fiber content and a
high pectin content, which may slow intestinal glucose uptake and
account, at least partially, for its hypoglycemic properties.
Studies have found distinct improvements in diabetics after nopal
ingestion, and the results suggest increased or enhanced insulin
sensitivity. Importantly, no negative side effects have been found
with nopal ingestion and use. The nopal petal also provides a rich
source of vitamins A and C.
[0010] Cinnamon and cinnamon extract is obtained from the bark of
the Cinnamomum cassia tree, and has long used a medicinal herb and
a spice. Studies done by the U.S. Agricultural Research Services
labs, and other labs, suggest that the cinnamon bark constituent,
methylhydroxy chalcone polymer ("MHCP") may be effective in
improving the responsiveness of peripheral tissues to insulin and
positively supporting sugar metabolism overall within the body.
MHCP is also known as type A procyanidin oligomers of cathechins
and epicatechins.
[0011] Biotin is a water-soluble B vitamin that is found in
animals, plants and microorganisms that enhances the secretion of
insulin in animals as well has playing an important role in the
metabolism of fatty acids, sugars, and alpha-amino acids. Biotin
supplementation has been shown to enhance insulin sensitivity and
increase the activity of glucokinase, which activates the
utilization of glucose by the liver. Biotin supplementation has
also been shown to significantly reduce fasting blood glucose
levels and improve blood glucose control in insulin dependent
diabetes meliltus and non-insulin dependent diabetics in several
studies.
[0012] Chlorogenic acid is a polyphenol found in berries, coffee
(particularly green coffee beans), other foods, and their extracts.
Studies have shown chlorogenic acid to be an inhibitor of hepatic
glucose-6-phosphate translocase, and this enzyme is responsible for
the production of endogenous glucose via gluconeogenesis and
glycogenolysis, both of which are important in the homeostatic
regulation of blood glucose levels. Inhibitors of
glucose-6-phosphate translocase may assist in the reduction of the
inappropriately high rates of hepatic glucose output, which is
commonly found in non-insulin dependant diabetes.
[0013] Pantothenic acid, also known as vitamin B5, is a
water-soluble vitamin that is essential to mammalian nutrition.
Pantothenic acid is necessary to form coenzyme-A, and is important
in a number of biological reactions, including the production of
energy, the catabolism of fatty acids and amino acids, the
synthesis of fatty acids, phospholipids, sphingolipids, cholesterol
and steroid hormones, and the synthesis of heme and the
neurotransmitter acetylcholine. It also appears to be involved in
the regulation of gene expression and in signal transduction.
[0014] The novel Composition combines ingredients, all of which are
naturally occurring, that synergistically retard intestinal glucose
uptake, enhance glucose metabolism, enhance uptake by cells, and
reduce inappropriately high hepatic glucose out. The Composition
accomplishes these facets of glycemic control and nutritional
support without negative side efforts, or negative ingredient
interactions. The Composition may also be ingested with little or
no interaction with traditional medications and medicaments.
[0015] The Composition may be formed into an easily ingestible
supplement, such as, for example, capsules, tablets, powders,
liquid concentrates, ready-made drinks, pastes and the like. In one
embodiment, the Composition may be formed as a capsule for
individual doses. The daily dosages for each ingredient of the
Composition fall within the following approximate ranges: 1 g
(gram) to 5 g of nopal or nopal extract; 100 mg (milligram) to 1 g
of cinnamon or cinnamon extract; 50 mg to 300 mg of chlorogenic
acid; 50 .mu.g (microgram) to 200 .mu.g of biotin; and 1 mg to 50
mg of pantothenic acid. Each of these ranges is within the
approximate daily dosage for a mammal. These ingredients may be
combined by any convenient or conventional means to a form useful
for ingestion or bodily absorption. A capsule may be formed in any
convenient size by any convenient method or conventional process,
often formed in a 500 mg size for ease of swallowing.
[0016] Where a capsule is formed into a 500 mg size, a proper
dosage level for a particular individual may include the ingestion
of more than one capsule. A 500 mg capsule may include the
Composition ingredients for combination in the approximate ranges
of: 200 mg to 400 mg of nopal or nopal extract; 25 mg to 75 mg of
cinnamon or cinnamon extract; 15 mg to 20 mg of chlorogenic acid;
25 .mu.g to 75 .mu.g of biotin; and, 1 mg to 4 mg of pantothenic
acid. An individual may choose to ingest one or more capsules, or a
plurality, as desired, according to the amount of Composition in
each capsule.
[0017] In another embodiment, a capsule may be formed in any larger
or smaller size, such as, for example, as a 750 mg size capsule. A
capsule in a 750 mg size would include ingredients in the
approximate general ranges of: 300 to 500 mg nopal or nopal
extract; 50 to 150 mg cinnamon or cinnamon extract; 25 to 50 mg
chlorogenic acid; 25 to 75 .mu.g of biotin; and 1 to 4 mg
pantothenic acid. A larger capsule size may be convenient to a
typical user since generally one capsule could provide a daily
dosage necessary to control glycemic deficits.
[0018] In alternative embodiments, the Composition may be formed
within the approximate, general ranges of ingredients as a powder,
a powder in a sachet, a tablet, a liquid concentrate, a ready-made
drink, nutritional bars, dermal patches from absorption through the
skin, or a paste format.
[0019] It will be appreciated that the novel Composition may be
advantageously used by humans, and other mammals, as nutritional
support to manage diabetes and other glycemic control problems
without negative side effects or chemical interactions typically
associated with traditional pharmaceuticals or medicines. In
addition, the positive synergistic affects of the ingredients of
the Composition provide greater benefits than single ingredients
and/or previously known combinations. Therefore, the Composition
may be readily used by those suffering with glycemic control
problems and avoid further health issues caused by negative
reactions and interactions that can often be debilitating for those
having previously compromised general health.
[0020] It should be understood that the description and examples
are only illustrative of the disclosure. Various alternatives and
modifications can be devised by those skilled in the art without
departing from the disclosure. Accordingly, the present disclosure
is intended to embrace all such alternatives, modifications and
variances which fall within the scope of the appended claims.
* * * * *