U.S. patent application number 16/123825 was filed with the patent office on 2019-01-03 for dietary supplements and formulations.
The applicant listed for this patent is Eastern Vision Limited. Invention is credited to Michael Holstein, Eric Huntington.
Application Number | 20190000931 16/123825 |
Document ID | / |
Family ID | 56620639 |
Filed Date | 2019-01-03 |
United States Patent
Application |
20190000931 |
Kind Code |
A1 |
Holstein; Michael ; et
al. |
January 3, 2019 |
DIETARY SUPPLEMENTS AND FORMULATIONS
Abstract
Provided are dietary supplements, formulations, kits and methods
for administration to an individual with type II diabetes or at
risk of developing type II diabetes. Provided herein are
formulations, kits and methods useful for treating, preventing,
supporting, controlling, restoring, and/or maintaining blood sugar
levels in individuals with type II diabetes or at risk of
developing the same. Also provided are formulations, kits and
methods useful for reducing and/or eliminating requirement of
ex-vivo insulin administration in an individual diagnosed with type
II diabetes.
Inventors: |
Holstein; Michael;
(Clearwater, FL) ; Huntington; Eric; (Clearwater,
FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Eastern Vision Limited |
Kowloon |
|
HK |
|
|
Family ID: |
56620639 |
Appl. No.: |
16/123825 |
Filed: |
September 6, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15240859 |
Aug 18, 2016 |
10105419 |
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16123825 |
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14662143 |
Mar 18, 2015 |
9446100 |
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15240859 |
|
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62116315 |
Feb 13, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61K 31/19 20130101;
A61K 31/525 20130101; A61K 36/53 20130101; A61K 31/355 20130101;
A61K 36/88 20130101; A61K 31/198 20130101; A61K 33/04 20130101;
A61K 33/24 20130101; A61K 33/34 20130101; A61K 36/185 20130101;
A61K 36/81 20130101; A61K 38/168 20130101; A61K 33/30 20130101;
A61K 38/446 20130101; A61K 31/25 20130101; A61K 31/197 20130101;
A61K 31/202 20130101; A61K 36/41 20130101; A61K 38/4873 20130101;
A61K 38/063 20130101; A61K 33/06 20130101; A61K 31/122 20130101;
A61K 31/455 20130101; A61K 31/59 20130101; A61K 31/592 20130101;
A61K 31/685 20130101; A61K 45/06 20130101; A61K 36/24 20130101;
A61K 38/465 20130101; A61K 31/4415 20130101; A61K 36/42 20130101;
A61K 31/16 20130101; A61K 31/375 20130101; A61K 31/145 20130101;
A61K 31/352 20130101; A61K 31/14 20130101; A61K 31/205 20130101;
A61K 31/519 20130101; A61K 31/733 20130101; A61K 31/7048 20130101;
A61K 31/714 20130101; A61K 35/60 20130101; A61K 31/12 20130101;
A61K 31/593 20130101; A61K 36/068 20130101; A61K 31/10 20130101;
A61K 31/185 20130101; A61K 31/047 20130101; A61K 38/54 20130101;
A61K 31/7076 20130101; A61K 31/4188 20130101; A61K 33/42 20130101;
A61K 31/07 20130101; A61K 38/47 20130101; A61K 31/385 20130101;
C12Y 115/01001 20130101; A61K 31/07 20130101; A61K 2300/00
20130101; A61K 31/10 20130101; A61K 2300/00 20130101; A61K 31/12
20130101; A61K 2300/00 20130101; A61K 31/14 20130101; A61K 2300/00
20130101; A61K 31/25 20130101; A61K 2300/00 20130101; A61K 31/375
20130101; A61K 2300/00 20130101; A61K 31/592 20130101; A61K 2300/00
20130101; A61K 31/593 20130101; A61K 2300/00 20130101; A61K 31/355
20130101; A61K 2300/00 20130101; A61K 31/525 20130101; A61K 2300/00
20130101; A61K 31/455 20130101; A61K 2300/00 20130101; A61K 31/4415
20130101; A61K 2300/00 20130101; A61K 31/519 20130101; A61K 2300/00
20130101; A61K 31/714 20130101; A61K 2300/00 20130101; A61K 31/197
20130101; A61K 2300/00 20130101; A61K 31/4188 20130101; A61K
2300/00 20130101; A61K 31/733 20130101; A61K 2300/00 20130101; A61K
31/352 20130101; A61K 2300/00 20130101; A61K 31/7048 20130101; A61K
2300/00 20130101; A61K 31/185 20130101; A61K 2300/00 20130101; A61K
31/205 20130101; A61K 2300/00 20130101; A61K 31/198 20130101; A61K
2300/00 20130101; A61K 31/7076 20130101; A61K 2300/00 20130101;
A61K 31/385 20130101; A61K 2300/00 20130101; A61K 33/30 20130101;
A61K 2300/00 20130101; A61K 33/04 20130101; A61K 2300/00 20130101;
A61K 33/24 20130101; A61K 2300/00 20130101; A61K 33/34 20130101;
A61K 2300/00 20130101; A61K 33/06 20130101; A61K 2300/00 20130101;
A61K 33/42 20130101; A61K 2300/00 20130101; A61K 31/122 20130101;
A61K 2300/00 20130101; A61K 31/685 20130101; A61K 2300/00 20130101;
A61K 38/168 20130101; A61K 2300/00 20130101; A61K 38/063 20130101;
A61K 2300/00 20130101; A61K 38/54 20130101; A61K 2300/00 20130101;
A61K 38/4873 20130101; A61K 2300/00 20130101; A61K 38/446 20130101;
A61K 2300/00 20130101; A61K 38/465 20130101; A61K 2300/00 20130101;
A61K 38/47 20130101; A61K 2300/00 20130101; A61K 36/24 20130101;
A61K 2300/00 20130101; A61K 36/41 20130101; A61K 2300/00 20130101;
A61K 36/42 20130101; A61K 2300/00 20130101; A61K 36/53 20130101;
A61K 2300/00 20130101; A61K 36/81 20130101; A61K 2300/00 20130101;
A61K 36/88 20130101; A61K 2300/00 20130101; A61K 36/068 20130101;
A61K 2300/00 20130101 |
International
Class: |
A61K 38/44 20060101
A61K038/44; A61K 31/59 20060101 A61K031/59; A61K 31/16 20060101
A61K031/16; A61K 31/19 20060101 A61K031/19; A61K 36/185 20060101
A61K036/185; A61K 31/047 20060101 A61K031/047; A61K 36/068 20060101
A61K036/068; A61K 33/42 20060101 A61K033/42; A61K 33/34 20060101
A61K033/34; A61K 33/30 20060101 A61K033/30; A61K 33/04 20060101
A61K033/04; A61K 31/733 20060101 A61K031/733; A61K 31/714 20060101
A61K031/714; A61K 31/7076 20060101 A61K031/7076; A61K 31/7048
20060101 A61K031/7048; A61K 31/593 20060101 A61K031/593; A61K
31/592 20060101 A61K031/592; A61K 31/525 20060101 A61K031/525; A61K
31/519 20060101 A61K031/519; A61K 31/455 20060101 A61K031/455; A61K
31/4415 20060101 A61K031/4415; A61K 31/375 20060101 A61K031/375;
A61K 31/355 20060101 A61K031/355; A61K 31/352 20060101 A61K031/352;
A61K 31/25 20060101 A61K031/25; A61K 31/205 20060101 A61K031/205;
A61K 31/198 20060101 A61K031/198; A61K 31/185 20060101 A61K031/185;
A61K 31/14 20060101 A61K031/14; A61K 31/12 20060101 A61K031/12;
A61K 31/10 20060101 A61K031/10; A61K 31/07 20060101 A61K031/07;
A61K 45/06 20060101 A61K045/06; A61K 38/48 20060101 A61K038/48;
A61K 38/47 20060101 A61K038/47; A61K 38/46 20060101 A61K038/46;
A61K 38/16 20060101 A61K038/16; A61K 36/88 20060101 A61K036/88;
A61K 33/24 20060101 A61K033/24; A61K 31/122 20060101 A61K031/122;
A61K 31/685 20060101 A61K031/685; A61K 36/41 20060101 A61K036/41;
A61K 36/53 20060101 A61K036/53; A61K 36/81 20060101 A61K036/81;
A61K 36/24 20060101 A61K036/24; A61K 36/42 20060101 A61K036/42;
A61K 31/4188 20060101 A61K031/4188; A61K 31/197 20060101
A61K031/197; A61K 38/54 20060101 A61K038/54; A61K 31/385 20060101
A61K031/385; A61K 38/06 20060101 A61K038/06; A61K 33/06 20060101
A61K033/06; A61K 31/202 20060101 A61K031/202; A61K 35/60 20060101
A61K035/60; A61K 31/145 20060101 A61K031/145 |
Claims
1. A dietary supplement in a form selected from the group
consisting of a tablet, capsule, pill, emulsion, ointment, lotion,
suppository, and aerosol, the dietary supplement consisting
essentially of: cactus stem extract; at least one component
selected from the group consisting of berberine, bitter melon
extract, Gymnema sylvestre leaf extract, banaba, carnitine, and
combinations thereof; at least one component selected from the
group consisting of Garcinia cambogia extract, Rehmannia glutinosa
extract, Poria cocos root extract, cinnamon extract, Fenugreek,
Guggul, and combinations thereof; at least one component selected
from the group consisting of vitamin D, vitamin E, thiamin,
riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin,
vitamin B5, magnesium, zinc, selenium, manganese, chromium,
vanadium, alpha lipoic acid, N-acetyl-cysteine, 4-aminobenzoic acid
(PABA), choline bitartarate, citrimax extract, taurine, coenzyme
Q10, calcium, vitamin K2, vitamin C, protein, fiber, inositol,
molybdenum, luo han guo, stevia extract rebaudioside, and
combinations thereof; and an excipient.
2. The dietary supplement of claim 1, wherein the excipient is
selected from the group consisting of gelatin, cellulose,
medium-chain triglyceride (MCT) oil, silicon dioxide, stearic acid,
and combinations thereof.
3. The dietary supplement of claim 1, wherein the dietary
supplement is used for supporting glucose level in a subject's
blood.
4. The dietary supplement of claim 1, wherein the dietary
supplement is used for reducing the need for insulin
administration.
5. The dietary supplement of claim 1, wherein the dietary
supplement supports, controls, restores, or maintains blood sugar
levels in a subject.
6. The dietary supplement of claim 5, wherein the subject suffers
from symptoms or complications associated with diabetes.
7. The dietary supplement of claim 5, wherein the subject suffers
from symptoms associated with type II diabetes.
8. The dietary supplement of claim 5, wherein the subject suffers
from symptoms associated with type I diabetes.
9. The dietary supplement of claim 5, wherein the subject has skin
complications, eye complications, foot complications, heart
diseases, or inflammation.
10. The dietary supplement of claim 5, wherein the subject has
neuropathy, diabetic ketoacidosis, kidney disease, hypertension,
gastroparesis, or high cholesterol.
11. The dietary supplement of claim 5, wherein the subject has
pre-diabetes.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This nonprovisional application is a divisional application
of and claims priority to nonprovisional application Ser. No.
15/240,859, entitled "Dietary Supplements and Formulations," filed
Aug. 18, 2016, by the same inventors, which is a divisional
application of and claims priority to nonprovisional application
Ser. No. 14/662,143, entitled "Dietary Supplements and
Formulations," filed Mar. 18, 2015, by the same inventors, which
claims the benefit of provisional application No. 62/116,315,
entitled "Dietary Supplements and Formulations," filed Feb. 13,
2015, by the same inventors, each of which is incorporated by
reference herein in their entireties.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] This invention relates, generally, to compositions for
treating disease. More specifically, it relates to dietary
supplements useful in maintaining safe blood sugar levels in
patients who have/are disposed to having diabetes.
2. Brief Description of the Prior Art
[0003] Diabetes mellitus (DM), commonly referred to as diabetes, is
a group of conditions characterized by high blood sugar levels
presented in a patient potentially over a prolonged duration of
time. Type II diabetes is a form of diabetes that is generally
associated with insulin resistance, a condition in which cells fail
to respond to insulin properly. As the disease progresses, a lack
of insulin may also develop. Type II diabetes was previously
referred to as "non-insulin-dependent diabetes mellitus" (NIDDM) or
"adult-onset diabetes."
[0004] Disclosed herein are dietary supplements, formulations and
methods useful for treating, preventing, supporting, controlling,
restoring, and/or maintaining blood sugar levels in individuals
suffering from pre-diabetic conditions and/or diabetes. The
formulations of dietary supplements and methods of use thereof
disclosed herein are also useful for treating, preventing,
supporting, controlling, restoring, and/or maintaining blood sugar
levels in an individual or a patient or for support or treatment of
other physiological conditions generally associated with type II
diabetes.
[0005] While certain aspects of conventional technologies have been
discussed to facilitate disclosure of the invention, Applicants in
no way disclaim these technical aspects, and it is contemplated
that the claimed invention may encompass one or more of the
conventional technical aspects discussed herein.
[0006] The present invention may address one or more of the
problems and deficiencies of the prior art discussed above.
However, it is contemplated that the invention may prove useful in
addressing other problems and deficiencies in a number of technical
areas. Therefore, the claimed invention should not necessarily be
construed as limited to addressing any of the particular problems
or deficiencies discussed herein.
[0007] In this specification, where a document, act or item of
knowledge is referred to or discussed, this reference or discussion
is not an admission that the document, act or item of knowledge or
any combination thereof was at the priority date, publicly
available, known to the public, part of common general knowledge,
or otherwise constitutes prior art under the applicable statutory
provisions, or is known to be relevant to an attempt to solve any
problem with which this specification is concerned
[0008] All referenced publications are incorporated herein by
reference in their entirety. Furthermore, where a definition or use
of a term in a reference, which is incorporated by reference
herein, is inconsistent or contrary to the definition of that term
provided herein, the definition of that term provided herein
applies and the definition of that term in the reference does not
apply.
BRIEF SUMMARY OF THE INVENTION
[0009] An object of the present disclosure is to provide dietary
supplements, formulations, kits and methods for administration to
an individual with type II diabetes, an individual who is at risk
of developing type II diabetes, or to a healthy individual that
desires to avoid developing diabetes. Provided herein are
formulations, kits and methods useful for treating, preventing,
supporting, controlling, restoring, or maintaining blood sugar
levels in individuals with type II diabetes or at risk of
developing the same. Also provided are formulations, kits and
methods useful for reducing and/or eliminating requirement of
ex-vivo insulin administration in an individual diagnosed with type
II diabetes.
[0010] In one aspect, provided herein is a formulation comprising:
a) group A components consisting essential of one or more protein;
b) at least one group B component that comprises dandelion extract,
milk thistle extract, phospholipids, ginger, taurine, turmeric
extract, vitamin C, methionine or combinations thereof, c) at least
one group C component that comprises magnesium, trimethylglycine,
glutathione, N-acetyl-cysteine, Cordyceps sinensis extract,
glutamine, alpha lipoic acid, glycine or combinations thereof; and
d) an excipient.
[0011] Also provided herein is a formulation comprising: group A
components consisting essentially of protein selected from the
group consisting of pea protein isolate, sacha inchi protein, hemp
protein, rice protein, artichoke protein, chia seed protein, beef
protein or combinations thereof; at least one group B component
that comprises dandelion extract, milk thistle extract,
phospholipids, ginger, taurine, turmeric extract, vitamin C,
methionine or combinations thereof; at least one group C component
that comprises magnesium, trimethylglycine, glutathione,
N-acetyl-cysteine, glutamine, alpha lipoic acid, glycine or
combinations thereof; at least one group D component that comprises
hesperidin, beet root, enzyme blend, sarsparilla root, bromelain,
betaine, methylsulfonylmethane (MSM), choline bitartarate,
primrose, inulin, watercress leaf, Panax ginseng root extract,
selenium, lecithin, or S-anenosylmethionine (SAM-e), thiamine,
vitamin B5, niacin, vitamin E, riboflavin, vitamin B6, folate,
vitamin B12, biotin, zinc, copper, molybdenum, carotene, calcium,
vitamin D, sodium phosphate, vitamin A, calcium, phosphorus,
chromium, triglyceride, quercetin, rutin, Marshmallow extract,
Jerusalem artichoke tuber, fiber or combinations thereof; and an
excipient. In some embodiments, the enzyme blend comprises a
lactase, a cellulase, a protease, a lipase, a dismutase, a
catalase, or a combination thereof.
[0012] Provided herein are formulations useful for treatment and/or
stabilization of individuals suffering from type II diabetes or at
risk of developing type II diabetes. In some embodiments, provided
is a formulation comprising: group A components consisting
essentially of protein selected from pea protein isolate, sacha
inchi protein, hemp protein, rice protein, artichoke protein, chia
seed protein, beef protein or combinations thereof; at least one
group B component that comprises dandelion extract, milk thistle
extract, phospholipids, ginger, taurine, turmeric extract, vitamin
C, methionine or combinations thereof; at least one group C
component that comprises magnesium, trimethylglycine, glutathione,
N-acetyl-cysteine, Cordyceps sinensis extract, glutamine, alpha
lipoic acid, glycine or combinations thereof; and an excipient. In
some embodiments, the formulation further comprises pea protein
isolate and sacha inchi protein. In some embodiments, the
formulation further comprises a protein derived from a source which
is not pea protein isolate. In some embodiments, the formulation
further comprises a protein derived from a source which is not
sacha inchi protein.
[0013] Further provided is a formulation comprising: group A
components consisting essentially of maca, Cornus officinalis fruit
extract or combinations thereof; at least one group B component
that comprises berberine, bitter melon extract, Gymnema sylestre
leaf extract, banaba, carnitine or combinations thereof; at least
one group C component that comprises vitamin C, Panax ginseng root
extract, Aswagandha root extract, holy basil leaf extract, Rhodiola
rosea extract, Eleutherococcus senticosus extract, vitamin B5,
cactus stem extract, phosphatidylserine, vitamin D or combinations
thereof; and an excipient. In some embodiments, the formulation
further comprises a fish oil formulation. The fish oil formulation
may comprise omega-3 at a range of about 15% to about 100%.
[0014] Also provided is a formulation comprising: group A
components consisting essentially of maca, Cornus officinalis fruit
extract or combinations thereof; at least one group B component
that comprises berberine, bitter melon extract, Gymnema sylvestre
leaf extract, banaba, or carnitine; at least one group C component
that comprises vitamin C, Panax ginseng root extract, Aswagandha
root extract, holy basil leaf extract, Rhodiola rosea extract,
Eleutherococcus senticosus extract, vitamin B5, cactus stem
extract, phosphatidylserine, vitamin D or combinations thereof; at
least one group D component that comprises Cordyceps sinesis
extract, Gingko biloba leaf extract, suma root, Garcinia cambogia
extract, Rehmannia glutinosa extract, Poria cocos root extract,
cinnamon extract, Fenugreek, Guggul, citrimax extract, salacia
oblonga extract, vitamin E, thiamin, riboflavin, niacin, vitamin
B6, folate, vitamin B12, biotin, magnesium, zinc, selenium,
manganese, chromium, vanadium, zinc, biotin, alpha lipoic acid,
N-acetyl-cysteine, 4-aminobenzoic acid (PABA), choline bitartrate,
glutamine, glutathione, protein, fiber, inositol or combinations
thereof; and an excipient.
[0015] Still further provided is a formulation comprising: group A
components consisting essentially of cactus stem extract; at least
one group B component that comprises berberine, bitter melon
extract, Gymnema sylvestre leaf extract, banaba, carnitine or
combinations thereof; at least one group C component that comprises
Garcinia cambogia extract, Rehmannia glutinosa extract, Poria cocos
root extract, cinnamon extract, Fenugreek, Guggul, Vitamin D or
combinations thereof; and an excipient.
[0016] Additionally provided is a formulation comprising: group A
component comprising cactus stem extract; at least one of group B
component that comprises berberine, bitter melon extract, Gymnema
sylvestre leaf extract, banaba, carnitine or combinations thereof;
at least one group C component that comprises Garcinia cambogia
extract, Rehmannia glutinosa extract, Poria cocos root extract,
cinnamon extract, Fenugreek, or Guggul; at least one group D
component that comprises vitamin D, vitamin E, thiamin, riboflavin,
niacin, vitamin B6, folate, vitamin B12, biotin, vitamin B5,
magnesium, zinc, selenium, manganese, chromium, vanadium, alpha
lipoic acid, N-acetyl-cysteine, 4-aminobenzoic acid (PABA), choline
bitartarate, citrimax extract, taurine, coenzyme Q10, calcium,
vitamin K2, vitamin C, protein, fiber, inositol or combinations
thereof; and an excipient.
[0017] In some embodiments is a formulation described herein,
wherein dandelion extract is dandelion root extract. In some
embodiments is a formulation described herein, wherein the
phospholipids comprise about 40% phosphatidylcholine. In some
embodiments is a formulation described herein, wherein the turmeric
extract comprises about 95% curcumin. In some embodiments is a
formulation described herein, wherein milk thistle extract is milk
thistle seed extract comprises about 80% silymarin. In some
embodiments is a formulation described herein, optionally further
comprising a gotu kola extract, which is optionally a gotu kola
leaf extract. In some embodiments is a formulation described
herein, wherein vitamin C comprises L-ascorbic acid, calcium
ascorbate, or a combination thereof. In some embodiments is a
formulation described herein, wherein magnesium is magnesium
citrate. In some embodiments is a formulation described herein,
wherein glutathione comprises L-glutathione, S-acetyl
L-glutathione, or a combination thereof. In some embodiments is a
formulation described herein, wherein N-acetyl-cysteine is N-Acetyl
L-cysteine. In some embodiments is a formulation described herein,
wherein Cordyceps sinensis extract comprises about 7% cordycepic
acid. In some embodiments is a formulation described herein,
wherein glutamine is L-glutamine. In some embodiments is a
formulation described herein, wherein alpha lipoic acid is alpha
R-lipoic acid. In some embodiments is a formulation described
herein, wherein glycine is L-glycine. In some embodiments is a
formulation described herein, further comprising at least one group
D component that comprises hesperidin, beet root, enzyme blend,
sarsaparilla root, bromelain, betaine, methylsulfonylmethane (MSM),
choline bitartarate, luo han guo, stevia extract rebaudioside,
primrose, inulin, watercress leaf, Panax ginseng root extract,
selenium, or S-anenosylmethionine (SAM-e). In some embodiments is a
formulation described herein, wherein luo han guo comprises about
40% mogrosides. In some embodiments is a formulation described
herein, wherein the stevia extract rebaudioside is stevia extract
97% rebaudioside. In some embodiments is a formulation described
herein, wherein the primrose is evening primrose oil powder. In
some embodiments is a formulation described herein, wherein
hesperidin is hesperidin complex. In some embodiments is a
formulation described herein, wherein beet root is beet root
powder. In some embodiments is a formulation described herein,
wherein the enzyme blend comprises a lactase, a cellulase, a
protease, a lipase, a dismutase, a catalase, or a combination
thereof. In some embodiments is a formulation described herein,
wherein betaine is betaine hydrochloride. In some embodiments is a
formulation described herein, wherein choline is choline
bitartarate. In some embodiments is a formulation described herein,
wherein the watercress leaf is watercress leaf powder. In some
embodiments is a formulation described herein, wherein selenium is
L-selenomethionine. In some embodiments is a formulation described
herein, further comprising at least one group E component that
comprises thiamine, vitamin B5, niacin, vitamin E, vitamin B6,
folate, vitamin B12, biotin, zinc, copper, molybdenum, carotene,
calcium, vitamin D, sodium phosphate, triglyceride, quercetin,
rutin, Marshmallow extract, or Jerusalem artichoke tuber.
[0018] In some embodiments is a formulation described herein,
wherein thiamine is optionally benfotiamine. In some embodiments is
a formulation described herein, wherein vitamin B5 comprises at
least one of pantothenic acid, pantethine, d-calcium pantothenate,
or a combination thereof. In some embodiments is a formulation
described herein, wherein niacin comprises at least one of
niacinamide, nicotinic acid, or a combination thereof. In some
embodiments is a formulation described herein, wherein vitamin E is
d-alpha tocopherol succinate. In some embodiments is a formulation
described herein, optionally further comprising riboflavin, wherein
said riboflavin is optionally riboflavin-5'-phosphate. In some
embodiments is a formulation described herein, wherein vitamin B6
comprises at least one of pyridoxal-5-phosphate, pyridoxine HCl, or
a combination thereof. In some embodiments is a formulation
described herein, wherein folate is L-5-methyltetrahydrofolate.
[0019] In some embodiments is a formulation described herein,
wherein vitamin B12 is methylcobalamin. In some embodiments is a
formulation described herein, wherein zinc is zinc glycinate. In
some embodiments is a formulation described herein, wherein copper
is copper gluconate. In some embodiments is a formulation described
herein, wherein molybdenum is molybdenum amino acid chelate. In
some embodiments is a formulation described herein, wherein
carotene is beta carotene. In some embodiments is a formulation
described herein, wherein calcium is calcium ascorbate. In some
embodiments is a formulation described herein, wherein vitamin D is
vitamin D3. In some embodiments is a formulation described herein,
wherein sodium phosphate is disodium phosphate. In some embodiments
is a formulation described herein, wherein the triglyceride is a
triglyceride comprising about 6-12 carbon fatty acid esters.
[0020] In some embodiments is a formulation described herein,
wherein quercetin is quercetin dihydrate. In some embodiments is a
formulation described herein, wherein Marshmallow extract is
Marshmallow root extract. In some embodiments is a formulation
described herein, wherein the concentration of pea protein isolate
in the formulation is from about 5% to about 70% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of sacha inchi protein in the formulation is from
about 0.5% to about 10% by weight. In some embodiments is a
formulation described herein, wherein the concentration of
dandelion extract in the formulation is from about 5% to about 40%
by weight. In some embodiments is a formulation described herein,
wherein the concentration of milk thistle extract in the
formulation is from about 3% to about 15% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of phospholipids in the formulation is from about 1%
to about 12% by weight. In some embodiments is a formulation
described herein, wherein the concentration of ginger in the
formulation is from about 1% to about 10% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of taurine in the formulation is from about 0.5% to
about 8% by weight.
[0021] In some embodiments is a formulation described herein,
wherein the concentration of turmeric extract in the formulation is
from about 0.5% to about 8% by weight. In some embodiments is a
formulation described herein, wherein the optionally comprising
gotu kola extract in a concentration up to about 8% by weight. In
some embodiments is a formulation described herein, wherein the
concentration of vitamin C in the formulation is from about 1% to
about 8% by weight. In some embodiments is a formulation described
herein, wherein the concentration of methionine in the formulation
is from about 1% to about 11% by weight. In some embodiments is a
formulation described herein, wherein the concentration of
magnesium in the formulation is from about 10% to about 55% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of trimethylglycine in the formulation is
from about 1% to about 40% by weight. In some embodiments is a
formulation described herein, wherein the concentration of
glutathione in the formulation is from about 0.5% to about 35% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of N-acetyl-cysteine in the formulation
is from about 0.5% to about 30% by weight. In some embodiments is a
formulation described herein, wherein the concentration of
Cordyceps sinensis extract in the formulation is from about 0.5% to
about 6% by weight. In some embodiments is a formulation described
herein, wherein the concentration of glutamine in the formulation
is from about 0.5% to about 6% by weight. In some embodiments is a
formulation described herein, wherein the concentration of alpha
lipoic acid in the formulation is from about 0.5% to about 6% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of glycine in the formulation is from
about 0.5% to about 6% by weight.
[0022] In some embodiments is a formulation described herein,
wherein the excipient comprises gelatin, cellulose, medium-chain
triglyceride (MCT) oil, silicon dioxide, stearic acid, xanthan gum,
potassium sorbate, turmeric powder, primrose oil, lemon oil, or
combinations thereof. In some embodiments is a formulation
described herein, wherein the formulation is in a powder form, a
semi-solid form, a liquid form, an emulsion form, or a combination
thereof.
[0023] In some embodiments is a formulation described herein,
further comprising at least one component that comprises
hesperidin, beet root, enzyme blend, sarsaparilla root, bromelain,
betaine, methylsulfonylmethane (MSM), choline bitartarate, luo han
guo, stevia extract rebaudioside, primrose, inulin, watercress
leaf, Panax ginseng root extract, selenium, or S-anenosylmethionine
(SAM-e). In some embodiments is a formulation described herein,
further comprising at least one component that comprises thiamine,
vitamin B5, niacin, vitamin E, riboflavin, vitamin B6, folate,
vitamin B12, biotin, zinc, copper, molybdenum, carotene, calcium,
vitamin D, sodium phosphate, triglyceride, quercetin, rutin,
Marshmallow extract, or Jerusalem artichoke tuber. In some
embodiments is a formulation described herein, wherein the
phospholipids comprise about 40% phosphatidylcholine. In some
embodiments is a formulation described herein, wherein the turmeric
extract comprises about 95% curcumin. In some embodiments is a
formulation described herein, wherein milk thistle extract is milk
thistle seed extract comprising about 80% silymarin.
[0024] In some embodiments is a formulation described herein,
further comprising gotu kola extract, wherein optionally said gotu
kola extract is gotu kola leaf extract. In some embodiments is a
formulation described herein, wherein vitamin C comprises
L-ascorbic acid, calcium ascorbate, or a combination thereof. In
some embodiments is a formulation described herein, wherein
glutathione comprises L-glutathione, S-acetyl L-glutathione, or a
combination thereof. In some embodiments is a formulation described
herein, wherein Cordyceps sinensis extract comprises about 7%
cordycepic acid. In some embodiments is a formulation described
herein, wherein luo han guo comprises about 40% mogrosides.
[0025] In some embodiments is a formulation described herein,
wherein the stevia extract rebaudioside is stevia extract 97%
rebaudioside. In some embodiments is a formulation described
herein, wherein the concentration of pea protein isolate in the
formulation is from about 5% to about 70, by weight. In some
embodiments is a formulation described herein, wherein the
concentration of sacha inchi protein in the formulation is from
about 0.5% to about 10% by weight.
[0026] In an embodiment is a formulation described herein, wherein
berberine is berberine hydrochloride. In some embodiments is a
formulation described herein, wherein carnitine is carnitine
tartrate. In some embodiments is a formulation described herein,
wherein carnitine is L-carnitine L-tartrate. In some embodiments is
a formulation described herein, wherein the Cordyceps sinesis
extract is a Cordyceps sinesis mycelium extract. In some
embodiments is a formulation described herein, wherein vitamin C is
L-ascorbic acid. In some embodiments is a formulation described
herein, wherein vitamin B5 comprises at least one of pantothenic
acid, pantethine, d-calcium pantothenate, or a combination thereof.
In some embodiments is a formulation described herein, wherein the
phosphatidylserine is a phospholipid complex supplement. In an
embodiment is a formulation described herein, wherein vitamin D is
a powder. In some embodiments is a formulation described herein,
further comprising at least one component that comprises Cordyceps
sinesis extract, Gingko biloba leaf extract, suma root, Garcinia
cambogia extract, Rehmannia glutinosa extract, Poria cocos root
extract, cinnamon extract, Fenugreek, or Guggul.
[0027] In some embodiments is a formulation described herein,
wherein Rehmannia glutinosa extract is Rehmania glutinosa rhizome
extract. In some embodiments is a formulation described herein,
wherein the Rehmania glutinosa rhizome extract is a Rehmania
glutinosa rhizome 5:1 extract.
[0028] In some embodiments is a formulation described herein,
further comprising a fish oil formulation. In some embodiments is a
formulation described herein, wherein the fish oil formulation
comprises omega-3 at a range of about 15% to about 100%. In some
embodiments is a formulation described herein, wherein the fish oil
formulation comprises eicosapentaenoic acid (EPA) at a range of
about 5% to about 100%. In some embodiments the fish oil
formulation comprises docosahexaenoic acid (DHA) at a range of
about 10% to about 100%. In some embodiments is a formulation
described herein, wherein the fish oil formulation is in a powder
form. In some embodiments is a formulation described herein,
wherein the fish oil formulation is in a liquid form. In some
embodiments is a formulation described herein, wherein the fish oil
formulation is in an emulsion form. In some embodiments is a
formulation described herein, wherein the fish oil formulation
further comprises one or more of citric acid, luo han guo, sodium
citrate, calcium glycinate amino acid complex, magnesium glycinate,
zinc glycinate chelate, zinc L-monomethionine,
pyridoxal-5-phosphate drum, niacin, molybdenum amino acid chelate,
taurine, lecithin, glycerine, and vitamin E.
[0029] In some embodiments is a formulation described herein,
further comprising at least one component that comprises one or
more of vitamin E, thiamin, riboflavin, niacin, vitamin B6, folate,
vitamin B12, biotin, magnesium, zinc, selenium, manganese,
chromium, vanadium, alpha lipoic acid, N-acetyl-cysteine,
4-aminobenzoic acid (PABA), choline bitartrate, or inositol. In
some embodiments is a formulation described herein, wherein the
concentration of berberine hydrochloride in the formulation is from
about 6% to about 28% by weight. In some embodiments is a
formulation described herein, wherein the concentration of bitter
melon extract in the formulation is from about 0.2% to about 18% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of Gymnema sylvestre leaf extract in the
formulation is from about 8% to about 18% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of banaba in the formulation is from about 0.2% to
about 18% by weight. In some embodiments is a formulation described
herein, wherein the concentration of cactus stem extract in the
formulation is from about 1% to about 8% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of L-carnitine L-tartrate in the formulation is from
about 1% to about 5% by weight. In some embodiments is a
formulation described herein, wherein the concentration of Garcinia
cambogia extract in the formulation is from about 0.1% to about 1%
by weight. In some embodiments is a formulation described herein,
wherein the concentration of Rehmannia glutinosa extract in the
formulation is from about 0.1% to about 3% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of Poria cocos root extract in the formulation is
from about 0.1% to about 1% by weight. In some embodiments is a
formulation described herein, wherein the concentration of cinnamon
extract in the formulation is from about 0.1% to about 1% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of Fenugreek extract in the formulation
is from about 0.1% to about 1% by weight.
[0030] In some embodiments is a formulation described herein,
wherein the concentration of Guggul extract in the formulation is
from about 0.1% to about 1% by weight. In some embodiments is a
formulation described herein, optionally comprising broad bean
extract which is optionally in a concentration from about 0.05% to
about 0.25% by weight. In some embodiments is a formulation
described herein, wherein the concentration of Cordyceps sinesis
extract in the formulation is from about 0.5% to about 3% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of maca in the formulation is from about
0.5% to about 3% by weight. In some embodiments is a formulation
described herein, wherein the concentration of Gingko biloba leaf
extract in the formulation is from about 0.5% to about 3% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of suma root extract in the formulation
is from about 0.5% to about 3% by weight. In some embodiments is a
formulation described herein, wherein the concentration of Cornus
officinalis fruit extract in the formulation is from about 0.5% to
about 3% by weight.
[0031] In some embodiments is a formulation described herein,
wherein the concentration of vitamin C in the formulation is from
about 2% to about 9% by weight. In some embodiments is a
formulation described herein, wherein the concentration of Panax
ginseng root extract in the formulation is from about 5% to about
21% by weight. In some embodiments is a formulation described
herein, wherein the concentration of Aswagandha root extract in the
formulation is from about 4% to about 16% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of holy basil leaf extract in the formulation is from
about 3% to about 13% by weight. In some embodiments is a
formulation described herein, wherein the concentration of Rhodiola
rosea extract in the formulation is from about 2% to about 10% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of Eleutherococcus senticosus extract in
the formulation is from about 1% to about 7% by weight.
[0032] In some embodiments is a formulation described herein,
wherein the concentration of vitamin B5 in the formulation is from
about 1% to about 7% by weight. In some embodiments is a
formulation described herein, wherein the concentration of
phosphatidylserine is from about 20% to about 90% by weight. In
some embodiments is a formulation described herein, wherein the
excipient comprises gelatin, cellulose, medium-chain triglyceride
(MCT) oil, silicon dioxide, stearic acid, or combinations
thereof.
[0033] In some embodiments is a formulation described herein,
optionally comprising broad bean. In some embodiments is a
formulation described herein, wherein berberine is berberine
hydrochloride. In some embodiments is a formulation described
herein, wherein carnitine is carnitine tartrate. In some
embodiments is a formulation described herein, wherein carnitine is
L-carnitine L-tartrate. In some embodiments is a formulation
described herein, wherein Rehmannia glutinosa extract is Rehmania
glutinosa rhizome extract. In some embodiments is a formulation
described herein, wherein the Rehmania glutinosa rhizome extract is
a Rehmania glutinosa rhizome 5:1 extract. In some embodiments is a
formulation described herein, wherein vitamin D is a powder. In
some embodiments is a formulation described herein, further
comprising at least one component that comprises vitamin E,
thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12,
biotin, vitamin B5, magnesium, zinc, selenium, manganese, chromium,
vanadium, alpha lipoic acid, N-acetyl-cysteine, 4-aminobenzoic acid
(PABA), choline bitartarate, or inositol. In some embodiments is a
formulation described herein, wherein vitamin E is d-alpha
tocopherol succinate. In some embodiments is a formulation
described herein, wherein thiamin is at least one of benfotiamine
and thiamine HCl. In some embodiments is a formulation described
herein, wherein riboflavin is roboflavin-5'-phosphate. In some
embodiments is a formulation described herein, wherein niacin
comprises at least one of niacinamide, nicotinic acid, or a
combination thereof. In some embodiments is a formulation described
herein, wherein vitamin B6 is at least one of pyridoxal-5-phosphate
and pyridoxine HCl. In some embodiments is a formulation described
herein, wherein folate is L-5-methyltetrahydrofolate.
[0034] In some embodiments is a formulation described herein,
wherein vitamin B12 is cyanocobalamin. In some embodiments is a
formulation described herein, wherein vitamin B5 comprises at least
one of pantothenic acid, d-calcium pantothenate, pantethine, or a
combination thereof. In some embodiments is a formulation described
herein, wherein magnesium is magnesium citrate.
[0035] In some embodiments is a formulation described herein,
wherein zinc is zinc glycinate. In some embodiments is a
formulation described herein, wherein selenium is
L-selenomethionine. In some embodiments is a formulation described
herein, wherein manganese is manganese gluconate. In some
embodiments is a formulation described herein, wherein chromium is
chromium niacin complex. In some embodiments is a formulation
described herein, wherein vanadium is vanadium sulfate. In some
embodiments is a formulation described herein, wherein alpha lipoic
acid is alpha R-lipoic acid. In some embodiments is a formulation
described herein, wherein N-acetyl-cysteine is N-Acetyl L-cysteine.
In some embodiments is a formulation described herein, wherein the
concentration of berberine hydrochloride in the formulation is from
about 6% to about 28% by weight. In some embodiments is a
formulation described herein, wherein the concentration of bitter
melon extract in the formulation is from about 0.2% to about 18% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of Gymnema sylvestre leaf extract in the
formulation is from about 8% to about 18% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of banaba in the formulation is from about 0.2% to
about 18% by weight. In some embodiments is a formulation described
herein, wherein the concentration of cactus stem extract in the
formulation is from about 3% to about 8% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of L-carnitine L-tartrate in the formulation is from
about 2% to about 5% by weight.
[0036] In some embodiments is a formulation described herein,
wherein the concentration of Garcinia cambogia extract in the
formulation is from about 0.2% to about 0.6% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of Rehmannia glutinosa extract in the formulation is
from about 0.2% to about 0.6% by weight.
[0037] In some embodiments is a formulation described herein,
wherein the concentration of Poria cocos root extract in the
formulation is from about 0.2% to about 0.6% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of cinnamon extract in the formulation is from about
0.2% to about 0.6% by weight. In some embodiments is a formulation
described herein, wherein the concentration of Fenugreek in the
formulation is from about 0.2% to about 0.6% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of Guggul in the formulation is from about 0.2% to
about 0.6% by weight.
[0038] In some embodiments is a formulation described herein,
optionally further comprising broad bean powder in a concentration
from about 0.2% to about 0.6% by weight. In some embodiments is a
formulation described herein, wherein the excipient comprises
gelatin, cellulose, medium-chain triglyceride (MCT) oil, silicon
dioxide, stearic acid, xanthan gum, potassium sorbate, turmeric
powder, primrose oil, lemon oil, or combinations thereof.
[0039] Provided herein are methods comprising administration of at
least one formulation described herein, for the treatment of
diabetes in subject. In some embodiments, provided are methods for
the treatment of pre-diabetic symptoms in a subject. In certain
embodiments, provided are methods for the regulation of blood sugar
in a subject. Certain methods described herein may comprise
administration of a formulation described herein for the regulation
of insulin levels in a subject.
[0040] Further provided are methods for the treatment of type II
diabetes in a subject comprising: administering to the subject a
first formulation described herein for at least about 10 days;
administering to the subject a second formulation described herein
for at least about 30 days; and optionally administering to the
subject a third formulation described herein. In some embodiments,
a formulation described herein is administered with an additional
agent. The additional agent may comprise insulin, metformin,
sulfonylureas, meglitinides, thiazolidinediones, DPP-4 inhibitors,
GLP-1 receptor agonists, SGLT2 inhibitors, or a combination
thereof.
[0041] In some embodiments, provided is a method of supporting
glucose level in a subject's blood comprising administering to the
subject one or more formulations described herein. In some
embodiments is a method of supporting glucose level in a subject's
blood comprising administering to the subject a formulation
described herein, and optionally administering to the subject a
second or additional formulation or agent described herein.
[0042] Provided are kits for use in the methods described herein.
In some embodiments, provided are kits comprising at least one
formulation described herein; and instructions for use thereof. In
certain embodiments, provided is a kit that further comprises at
least one diet plan or meal plan. In some embodiments, the kit
further comprises at least one recipe.
[0043] In some embodiments is a kit useful for treating,
preventing, supporting, controlling, restoring, or maintaining
blood sugar levels in an individual comprising: at least one
formulation described herein; instructions for use of the at least
one formulation; and optionally at least one diet plan.
[0044] A diet plan described herein may further comprise recipes.
In some embodiments, the diet plan further comprises recipes for at
least one of breakfast, lunch, snacks, and dinner. In some
embodiments, at least one diet plan is tailored to complement said
at least one formulation. In some embodiments, the diet plan is
tailored based on the level of at least one indicator in the
individual. In certain cases, the at least one indicator is body
mass index (BMI), liver fat level or hemoglobin A1C count.
[0045] In some embodiments provided herein are diet plans (also
referred to as diet regimens or regimens) for implementation in
conjugation with the methods and formulations described herein. A
diet plan described herein is optionally included in a method
and/or kit described herein. In certain embodiments, a diet plan
described herein is tailored for the individual based on an
understanding of the symptoms exhibited by the individual. In some
embodiments, a diet plan described herein works in synergy with a
method and/or formulation described herein to achieve a desired
result. In some embodiments, the desired result in a reduction or
stabilization of blood glucose levels. In certain embodiments, the
desired result is a reduction or elimination of insulin
administration. In certain embodiments, the desired result is a
reduction in BMI. In certain embodiments, the desired result is a
reduction or elimination of one or more symptoms of type II
diabetes or an associated condition described herein.
[0046] Additional aspects and advantages of the present disclosure
will become readily apparent to those skilled in this art from the
following detailed description, wherein only illustrative
embodiments of the present disclosure are shown and described. As
will be realized, the present disclosure is capable of other and
different embodiments, and its several details are capable of
modifications in various obvious respects, all without departing
from the disclosure. Accordingly, the drawings and description are
to be regarded as illustrative in nature, and not as
restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0047] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings or figures (also "FIG."
and "FIGS." herein), of which:
[0048] FIG. 1A provides a summary of clinical improvement in
individuals diagnosed with type II diabetes upon use of the dietary
supplement formulations and methods described herein. FIG. 1A shows
that in an exemplary case study, upon administration of dietary
supplement formulations provided herein, insulin requirement was
reduced from 30 units daily to 10 units daily, and the requirement
for insulin was eliminated after 4 months of administration of
dietary supplement formulations provided herein. FIG. 1A also shows
a significant drop in blood glucose levels as demonstrated by a two
point drop in hemoglobin A1C upon four months of administration of
formulations described herein.
[0049] FIG. 1B provides a summary of clinical improvement in
individuals diagnosed with type II diabetes upon use of the dietary
supplement formulations and methods described herein. FIG. 1B shows
that in another exemplary case study, upon administration of
dietary supplement formulations provided herein, the individual was
able to reduce insulin requirement, lost 20 lb without any
additional exercise and felt an improvement in foot pain and energy
levels.
[0050] FIG. 1C provides a summary of clinical improvement in
individuals diagnosed with type II diabetes upon use of the dietary
supplement formulations and methods described herein. FIG. 1C shows
that in a further exemplary case study, the individual was able to
reduce insulin requirement within one week upon administration of
dietary supplement formulations provided herein. FIG. 1C also
demonstrates that regular administration of dietary supplement
formulations provided herein resulted in a two-fold reduction in
blood sugar levels, and elimination of requirements for cholesterol
medication and insulin.
[0051] FIG. 2 provides results of statistical survey of 151
diabetic individuals who were administered formulations and diet
plans described herein.
DETAILED DESCRIPTION OF THE INVENTION
[0052] While various embodiments of the invention have been shown
and described herein, it will be obvious to those skilled in the
art that such embodiments are provided by way of example only.
Numerous variations, changes, and substitutions may occur to those
skilled in the art without departing from the invention. It should
be understood that various alternatives to the embodiments of the
invention described herein may be employed. It shall be understood
that different aspects of the invention can be appreciated
individually, collectively, or in combination with each other.
[0053] An object of the present disclosure is to provide dietary
supplements, formulations and methods for administration to an
individual with type II diabetes or at risk of developing type II
diabetes. Provided herein are formulations and methods useful for
treating, preventing, supporting, controlling, restoring, and/or
maintaining blood sugar levels in individuals with type II diabetes
or at risk of developing the same. Also provided are formulations
and methods useful for reducing and/or eliminating requirement of
ex-vivo insulin administration in an individual diagnosed with type
II diabetes.
[0054] Provided herein are methods and formulations of dietary
supplements that when administered to an individual treat, support
and/or enhance at least one of: detoxification, eyes and ears
health, natural blood sugar metabolism, male reproductive health,
weight control, skin, soft tissue, skeletal tissue health, natural
blood sugar levels, female reproductive health, healthy blood
pressure levels, male sexual function health, glutathione levels,
connective tissue health, triglyceride levels, circulatory system
health, homocysteine levels, musculoskeletal health, LDL levels,
antioxidant health, energy levels, reproductive health, natural pH
levels, natural insulin response to glucose load, healthy HDL
cholesterol levels, natural stress responses, natural glutathione
levels, natural growth and repair of tissues, natural biliary
levels, natural glucose tolerance, adrenal function, natural
insulin receptor site sensitivity, platelet function, natural
recovery time, brain function and memory, natural nerve
transmission, heart and cardiovascular health, natural cell
division, liver health, natural breakdown of fats, insulin health,
natural bone growth, natural white blood cell levels, natural
tryptophan metabolism, healthy red blood cells, natural
thermogenesis, small blood vessel health, natural iron and sugar
utilization, health and integrity of cellular tissue, natural
secretions of insulin and glucagon, the immune system health,
natural nutrient utilization, metabolism health, natural absorption
of minerals, cardiovascular health, natural protein synthesis,
kidney health, natural production of nucleic acids, creatine
phosphate, gall bladder health, natural heme production, muscle
health, natural enzymatic reactions, bone health, healthy stress
responses, oral health, methionine metabolism, joint health,
maintenance of a healthy nervous system, hormone health, appetite
control, digestion health, glycemic control, colon health, gene
expression, menstruation health, cellular repair, scalp health,
nutrient transportation, intestinal health, adrenal hormones,
respiratory health, chemical reactions, healthy hair, mucous
membranes, and nails and overall physical and mental well-being
health.
[0055] Provided herein are methods and formulations of dietary
supplements that when administered to an individual treat, support
and/or enhance at least one of: neutralization of toxins, eyes and
ears health, natural blood sugar metabolism, male reproductive
health, weight control, skin/soft tissue/skeletal tissue health,
natural blood sugar levels, female reproductive health, healthy
blood pressure levels, male sexual function health, beta cells of
the pancreas, connective tissue health, removal of heavy metal
toxins, circulatory system health, homocysteine levels,
musculoskeletal health, LDL levels, antioxidant health, energy
levels, reproductive health, natural pH levels, natural cellular
uptake of glucose, healthy HDL cholesterol levels, natural stress
responses, natural glutathione levels, natural growth and repair of
tissues, natural biliary levels, natural glucose tolerance, adrenal
function, natural insulin receptor site sensitivity, platelet
function, natural recovery time, brain function and memory, natural
nerve transmission, heart and cardiovascular health, natural cell
division, liver health, natural breakdown of fats, insulin health,
natural bone growth, natural white blood cell levels, natural
tryptophan metabolism, healthy red blood cells, natural
thermogenesis, small blood vessel health, natural iron and sugar
utilization, health and integrity of cellular tissue, natural
secretions of insulin and glucagon, the immune system health,
natural nutrient utilization, metabolism health, natural absorption
of minerals, cardiovascular health, natural protein synthesis,
kidney health, natural production of nucleic acids, creatine
phosphate, gall bladder health, natural heme production, muscle
health, natural enzymatic reactions, bone health, healthy stress
responses, oral health, methionine metabolism, joint health,
maintain a healthy nervous system, hormone health, appetite
control, digestion health, glycemic control, colon health, gene
expression, menstruation health, cellular repair, scalp health,
nutrient transportation, intestinal health, adrenal hormones, beta
cells of the pancreas, chemical reactions, healthy hair/mucous
membranes/nails and physical and mental well-being. In certain
embodiments, the formulations and methods further comprise fish
oils or derivatives thereof, administration of which enhances
and/or supports at least one of: heart health, cardiovascular
health, immune system, natural liver function, natural hormones
function, natural brain function, cell health, natural adrenal
glands function, healthy cholesterol levels, normal blood pressure
levels and insulin health.
[0056] Provided herein are methods and formulations of dietary
supplements that when administered to an individual treat, support
and/or enhance at least one of: blood sugar metabolism, healthy
hair/mucous membranes/nails, weight control, adrenal function,
natural blood sugar levels, natural fat burning, healthy blood
pressure levels, cognitive function, beta cells of the pancreas,
eyes and ears health, triglyceride levels, male reproductive
health, natural white blood cell levels, female reproductive
health, LDL levels, antioxidant health, energy levels, neuro
protection, pH levels, cellular uptake of glucose, healthy HDL
cholesterol levels, stamina, glutathione levels, glucokinase
activity, natural biliary levels, GABA, natural hormone levels,
natural insulin receptor site sensitivity, brain function and
memory, natural insulin health, platelet function, natural adrenal
hormones, heart and cardiovascular health, natural adrenal glands
function, natural liver function, nutrient transportation, insulin
health, digestion health, healthy red blood cells, glycemic
control, colon health, healthy uric acid levels, small blood vessel
health, gene expression, gastrointestinal health, physical and
mental well-being health, hormone health, maintain a healthy
nervous system, health and integrity of cellular tissue, natural
secretions of insulin and glucagon, the immune system health, joint
health, healthy metabolic processes, secretions of insulin and
glucagon, glucose tolerance, natural enzymatic reactions,
tryptophan metabolism, intestinal health, kidney health, cartilage,
thyroid health, peripheral glucose utilization, muscle health,
natural insulin production, bone health, natural stress responses,
oral health, methionine metabolism, the manufacture and utilization
of carbohydrates/fats/amino acids, and formation of
fats/proteins/carbohydrates/amino acids/antibiotics. In certain
embodiments, the formulations and methods further comprise fish
oils or derivatives thereof, administration of which enhances
and/or supports at least one of: heart health, cardiovascular
health, immune system, natural liver function, natural hormones
function, natural brain function, cell health, natural adrenal
glands function, healthy cholesterol levels, normal blood pressure
levels and insulin health.
[0057] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as is commonly understood by one
of skill in the art to which the claimed subject matter
belongs.
[0058] It is to be understood that the foregoing general
description and the following detailed description are exemplary
and explanatory only and are not restrictive of any subject matter
claimed. In this application, the use of the singular includes the
plural unless specifically stated otherwise.
[0059] In the present description, any concentration range,
percentage range, ratio range, or integer range is to be understood
to include the value of any integer within the recited range and,
when appropriate, fractions thereof (such as one tenth and one
hundredth of an integer), unless otherwise indicated. As used
herein, "about" means 10% of the indicated range, value, sequence,
or structure, unless otherwise indicated. It should be understood
that the terms "a" and "an" as used herein refer to "one or more"
of the enumerated components unless otherwise indicated or dictated
by its context. The use of the alternative (e.g., "or") should be
understood to mean either one, both, or any combination thereof of
the alternatives. As used herein, the terms "include" and
"comprise" are used synonymously.
[0060] It is to be understood that the methods, formulations and
compositions described herein are not limited to the particular
methodology, protocols, methods, and reagents described herein and
as such may vary. It is also to be understood that the terminology
used herein is for the purpose of describing particular embodiments
only, and is not intended to limit the scope of the methods and
compositions described herein, which will be limited only by the
appended claims.
[0061] Exemplary Ingredients
[0062] The methods, dietary supplements and formulations described
herein may comprise at least one of the ingredients discussed
below. In certain embodiments, formulations described herein
comprise a plurality of ingredients described below. In certain
embodiments, two or more ingredients are combined in an amount
suitable to provide synergistic effects. Formulations and dietary
supplements described herein may contain other active and inactive
ingredients in addition to one or more ingredients described
herein.
[0063] Biotin: Alternatively called vitamin H or coenzyme R a
water-soluble B-vitamin (vitamin B7). Certain methods and
formulations described herein comprise a suitable amount of biotin
or derivative or analog thereof. In certain embodiments, methods
and formulations of dietary supplements comprise biotin or
derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: blood sugar control, cholesterol
levels, insulin response to glucose load, manufacture and
utilization of carbohydrates/fats/amino acids, maintenance of
insulin receptor site sensitivity, glucokinase activity, hair
growth, nail health and metabolism.
[0064] Chromium Picolinate: In some embodiments, the source of
chromium is chromium polynicotinate. Certain methods and
formulations described herein comprise a suitable amount of
chromium piclionate or derivative or analog thereof, including for
instance any type of chromium. In certain embodiments, methods and
formulations of dietary supplements comprise chromium piclionate or
derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: blood sugar level, cholesterol
level, optimizing the impact of insulin on insulin receptor sites,
thermogenesis, healthy triglyceride levels, healthy HDL
cholesterol, metabolism, regulating food cravings and normal blood
pressure.
[0065] Vitamin A: is a group of unsaturated nutritional organic
compounds, that includes retinol, retinal, retinoic acid, and
several provitamin A carotenoids, among which beta-carotene is the
most important. Certain methods and formulations described herein
comprise a suitable amount of vitamin A or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise vitamin A or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: eye health, healthy vision, cofactors for toxin breakdown,
homocysteine levels, moisture levels for eyes/skin/mucous
membranes, antioxidant levels, heart health, skin/soft
tissue/skeletal tissue health.
[0066] Vitamin C or L-ascorbic acid, or ascorbate: Certain methods
and formulations described herein comprise a suitable amount of
vitamin C or derivative or analog thereof. In certain embodiments,
methods and formulations of dietary supplements comprise vitamin C
or derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: neutralization of toxins,
glutathione levels, immune system, removal of heavy metal toxins,
blood sugar metabolism, beta cells of the pancreas, antioxidation,
and growth and repair of tissues.
[0067] Vitamin D: In some embodiments, the source of Vitamin D is
vitamin D3 (also known as cholecalciferol). In some embodiments,
the source of Vitamin D is vitamin D2 (ergocalciferol). Certain
methods and formulations described herein comprise a suitable
amount of vitamin D or derivative or analog thereof. In certain
embodiments, methods and formulations of dietary supplements
comprise vitamin D or derivative or analog thereof in an amount
suitable to support and/or enhance at least one of: blood sugar
metabolism, heart and cardiovascular health, immune function,
insulin receptor site activity, bone health, reducing the risk of
some forms of cancer, alleviating musculoskeletal pain
[0068] Vitamin E: In some embodiments the source of Vitamin E is a
tocopherol. In some embodiments, the source of Vitamin E is a
tocotrienol. In some embodiments, tocopherol is .gamma.-tocopherol.
In some embodiments, tocopherol is a-tocopherol. In some
embodiments, the source of Vitamin E is a-tocopherol succinate.
Certain methods and formulations described herein comprise a
suitable amount of vitamin E or derivative or analog thereof. In
certain embodiments, methods and formulations of dietary
supplements comprise vitamin E or derivative or analog thereof in
an amount suitable to support and/or enhance at least one of: free
radical elimination, health and integrity of cellular tissue,
healthy insulin receptor site activity, triglyceride levels, LDL
levels, platelet function, glycemic control, antioxidant levels,
and immune function.
[0069] Vitamin B1: In some embodiments, the source of Vitamin B1 is
thiamine (or thiamin). In some embodiments, the source of Vitamin
B1 is thiamine hydrochloride. In some embodiments, the source of
vitamin B1 is Benfotiamine. Certain methods and formulations
described herein comprise a suitable amount of vitamin B1 or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise vitamin B1 or
derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: cofactor levels for energy
production, antioxidation, neuro-protection, small blood vessel
health, blood sugar metabolism, cholesterol levels, energy
production, heart and cardiovascular health, and brain function and
memory.
[0070] Vitamin B2 or riboflavin: Certain methods and formulations
described herein comprise a suitable amount of vitamin B2 or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise vitamin B2 or
derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: antioxidation, energy production,
immune function, energy levels, maintenance of healthy hair, skin,
mucous membranes, and nails, reproductive function, liver and
memory.
[0071] Niacin also known as vitamin B3 or nicotinic acid: Certain
methods and formulations described herein comprise a suitable
amount of niacin or derivative or analog thereof. In certain
embodiments, methods and formulations of dietary supplements
comprise niacin or derivative or analog thereof in an amount
suitable to support and/or enhance at least one of: energy
production, oxidation, cholesterol levels, blood sugar metabolism,
beta cells of the pancreas, adrenal function, support and
maintenance of a healthy nervous system, one or more metabolic
processes, and healthy cardiovascular function.
[0072] Vitamin B6: In some embodiments, the source of Vitamin B6 is
Pyridoxal 5'-phosphate (PLP). In some embodiments, the source of
Vitamin B6 is pyridoxine. Certain methods and formulations
described herein comprise a suitable amount of vitamin B6 or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise vitamin B6 or
derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: antioxidation, energy production,
homocysteine levels, blood sugar metabolism, glucose tolerance,
secretions of insulin and glucagon, tryptophan metabolism and
neuro-protection.
[0073] Vitamin B12 also called cobalamin: In some embodiments the
source of vitamin B12 is methylcobalamin. In some embodiments, the
source of Vitamin B12 is cyanocobalamin. Certain methods and
formulations described herein comprise a suitable amount of vitamin
B12 or derivative or analog thereof. In certain embodiments,
methods and formulations of dietary supplements comprise vitamin
B12 or derivative or analog thereof in an amount suitable to
support and/or enhance at least one of: healthy homocysteine
levels, healthy red blood cells, energy production, immune system
and neuro-protection.
[0074] Magnesium: In some embodiments, the source of magnesium is
magnesium citrate. In some embodiments, the source of magnesium is
magnesium glycinate. Certain methods and formulations described
herein comprise a suitable amount of magnesium or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise magnesium or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: mood stabilization, muscle health, blood pressure,
cardiovascular system, bone health, metabolism, blood sugar levels,
insulin receptor site sensitivity, cholesterol levels and platelet
activity.
[0075] Ginseng: In some embodiments, the ginseng is Asian or Korean
ginseng (Panax ginseng). In some embodiments, the ginseng is
American ginseng (Panax quinquefolius). Certain methods and
formulations described herein comprise a suitable amount of ginseng
or derivative or analog thereof. In certain embodiments, methods
and formulations of dietary supplements comprise ginseng or
derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: immune function, carbohydrate
absorption by the intestines, blood sugar metabolism, insulin
production, menstruation, weight control, physical and mental
well-being and male sexual function
[0076] Fenugreek: Certain methods and formulations described herein
comprise a suitable amount of fenugreek or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise fenugreek or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: blood sugar metabolism, insulin sensitivity, cholesterol
levels, insulin production, minerals inclusive of iron, potassium,
calcium, selenium, copper, zinc, manganese, and magnesium, thiamin,
folic acid, riboflavin, pyridoxine (vitamin B6), niacin, and
vitamins A and C. LDL levels and mental aging.
[0077] Holy Basil Leaf also known as Ocimum sanctum, Ocimum
tenuifloru or Tulsi: Certain methods and formulations described
herein comprise a suitable amount of holy basil leaf or derivative
or analog thereof. In certain embodiments, methods and formulations
of dietary supplements comprise holy basil leaf or derivative or
analog thereof in an amount suitable to support and/or enhance at
least one of: blood sugar metabolism, stress responses, immune
responses, platelet activity, cholesterol levels, storage of
glucose as glycogen, adaptogen and therefore supports healthy
stress responses, and support for gastro-intestinal health.
[0078] Bitter Melon: Certain methods and formulations described
herein comprise a suitable amount of bitter melon or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise bitter melon or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: blood sugar metabolism, pancreatic beta cells,
gastro-intestinal health, and liver function.
[0079] Gymnema also known as Gymnema Sylvestre: Certain methods and
formulations described herein comprise a suitable amount of gymnema
or derivative or analog thereof. In certain embodiments, methods
and formulations of dietary supplements comprise gymnema or
derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: blood sugar metabolism, sugar
cravings, insulin responses, insulin receptor site sensitivity,
cholesterol levels, weight loss, digestion, and pancreatic beta
cells.
[0080] Prickly Pear Cactus (Nopal): Certain methods and
formulations described herein comprise a suitable amount of prickly
pear cactus or derivative or analog thereof. In certain
embodiments, methods and formulations of dietary supplements
comprise prickly pear cactus or derivative or analog thereof in an
amount suitable to support and/or enhance at least one of: blood
sugar metabolism and regulation of cholesterol levels.
[0081] Cinnamon: Certain methods and formulations described herein
comprise a suitable amount of cinnamon or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise cinnamon or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: blood sugar metabolism, digestion, appetite normalization,
alleviation of fungal infection, and cholesterol levels.
[0082] Vanadium: Certain methods and formulations described herein
comprise a suitable amount of vanadium or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise vanadium or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: blood sugar metabolism, cholesterol levels, heart health
and water retention. In some embodiments, the source of vanadium is
vanadium sulfate.
[0083] Lipoic Acid: Certain methods and formulations described
herein comprise a suitable amount of Lipoic Acid or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise Lipoic Acid or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: blood sugar metabolism, enzymatic reactions in the body,
insulin sensitivity, mediation of oxidative stress, liver, bone
health, eye health, neurological system, skin, blood pressure,
cholesterol and weight regulation. In some embodiments, lipoic acid
is R-lipoic acid.
[0084] Zinc: Certain methods and formulations described herein
comprise a suitable amount of zinc or derivative or analog thereof.
In certain embodiments, methods and formulations of dietary
supplements comprise zinc or derivative or analog thereof in an
amount suitable to support and/or enhance at least one of: immune
function, cell division, hormone levels, antioxidation, healthy
stress responses, red blood cells, white blood cells, male
reproductive health, female reproductive health, cardiovascular
system, blood sugar metabolism, brain health, cholesterol
stabilization and mood stabilization. In some embodiments, the
source of zinc is zinc glycinate. In some embodiments the source of
zinc is zinc L-monomethionine.
[0085] Calcium: Certain methods and formulations described herein
comprise a suitable amount of calcium or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise calcium or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: bone health, nerve transmission, blood sugar metabolism,
oral health, weight regulation, colon health, muscle health, heart
health, normal blood pressure, blood sugar metabolism, joint
health, kidney health, pH level, and nutrient transportation. In
some embodiments calcium is calcium ascorbate. In some embodiment
calcium is calcium citrate malate.
[0086] Selenium: Certain methods and formulations described herein
comprise a suitable amount of selenium or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise selenium or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: thyroid health, DNA synthesis, immune function,
reproduction, blood sugar metabolism, antioxidation, and bone
growth. In some embodiments, the source of selenium is
L-selenomethionine.
[0087] Artichoke extract: Certain methods and formulations
described herein comprise a suitable amount of artichoke extract or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise artichoke extract or
derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: cholesterol, heart function, liver
function, blood sugar metabolism, antioxidation, digestion, and
apoptosis.
[0088] Ginkgo Biloba: Certain methods and formulations described
herein comprise a suitable amount of gingko biloba, extract or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise gingko biloba, extract
or derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: platelet function, memory, blood
flow to the brain, oxygen utilization, vision, eyes, and mood
stabilization.
[0089] Vitamin B5. In some embodiments, the source of Vitamin B5 is
Pantothenic Acid. In some embodiments the source of vitamin B5 is
calcium pantothenate. In some embodiments, the source of Vitamin B5
is pantethine. Certain methods and formulations described herein
comprise a suitable amount of Vitamin B5 or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise Vitamin B5 or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: acetylcholine, hair, mood stabilization, stress responses,
heart health, immune health, joint health, adrenal hormones,
formation of fats/proteins/carbohydrates/amino acids/antibiotics,
and stamina.
[0090] Phosphorus: Certain methods and formulations described
herein comprise a suitable amount of phosphorous or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise phosphorus or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: bone, digestion, hormones, energy, cellular repair,
chemical reactions, proper nutrient utilization, kidneys, brain
support and protein formation. In some embodiments, the source of
phosphorus is disodium phosphate.
[0091] Copper: Certain methods and formulations described herein
comprise a suitable amount of copper or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise copper or derivative or analog thereof
in an amount suitable to support and/or enhance at least one of:
joint health, proper growth, connective tissues, brain, enzymatic
reactions, iron and sugar utilization, energy production, thyroid
health, red blood cell formation, immune system, and healthy
cholesterol levels. In some embodiments, the source of copper is
copper gluconate.
[0092] Manganese: Certain methods and formulations described herein
comprise a suitable amount of manganese or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise manganese or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: GABA, bones, antioxidation, blood sugar metabolism, overall
metabolism, inflammation alleviation, thyroid, absorption, brain,
nervous system and digestion. In some embodiments, the source of
manganese is manganese gluconate.
[0093] Molybdenum: Certain methods and formulations described
herein comprise a suitable amount of molybdenum or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise molybdenum or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: uric acid stabilization, sulfation, enzyme levels,
inflammation alleviation, and detoxification. In some embodiments
the source of molybdenum is molybdenum amino acid chelate.
[0094] Trimethylglycine: Certain methods and formulations described
herein comprise a suitable amount of trimethylglycine or derivative
or analog thereof. In certain embodiments, methods and formulations
of dietary supplements comprise trimethylglycine or derivative or
analog thereof in an amount suitable to support and/or enhance at
least one of: methionine metabolism, homocysteine levels and liver
function.
[0095] Evening Primrose Oil also known as Cis-Linoleic Acid Certain
methods and formulations described herein comprise a suitable
amount of evening primrose oil or derivative or analog thereof. In
certain embodiments, methods and formulations of dietary
supplements comprise evening primrose oil or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: skin health and function, inflammation alleviation,
menstruation, neuro-protection, memory, nails, scalp, and hair,
prostaglandin E2, and gastro-intestinal tract.
[0096] Inulin: Certain methods and formulations described herein
comprise a suitable amount of inulin or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise inulin or derivative or analog thereof
in an amount suitable to support and/or enhance at least one of:
intestinal health, immune system, short-chain fatty acids, liver,
cardiovascular functions, absorption of minerals and digestion.
[0097] Medium Chain Triglycerides: Certain methods and formulations
described herein comprise a suitable amount of medium chain
triglycerides or derivative or analog thereof. In certain
embodiments, methods and formulations of dietary supplements
comprise medium chain triglycerides or derivative or analog thereof
in an amount suitable to support and/or enhance at least one of:
absorption, energy, weight control, appetite control,
cardiovascular system, and immune system.
[0098] Quercetin, also known as 3,3',4'5,7-Pentahydroxyflavone,
bioflavonoid, bioflavonoid complex, bioflavonoid concentrate,
bioflavonoid extract: In some embodiments, the source of quercetin
is quercetin dihydrate. Certain methods and formulations described
herein comprise a suitable amount of quercetin or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise quercetin or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: antioxidation, inflammation alleviation, histamine
regulation, respiratory health, cardiovascular system, blood
pressure regulation and stress management.
[0099] Rutin, also called rutoside, quercetin-3-O-rutinoside and
sophorin: Certain methods and formulations described herein
comprise a suitable amount of rutin or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise rutin or derivative or analog thereof
in an amount suitable to support and/or enhance at least one of:
antioxidation, inflammation alleviation, utilization of vitamin C,
high blood pressure regulation, hemorrhoid alleviation, cholesterol
and blood vessel health.
[0100] Hesperidin: Certain methods and formulations described
herein comprise a suitable amount of hersperidin or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise hersperidin or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: antioxidation, inflammation alleviation, blood pressure
regulation, and blood vessel health.
[0101] Milk thistle, also known as silybum marianum, or silymarin:
Certain methods and formulations described herein comprise a
suitable amount of milk thistle or extract or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise milk thistle or extract or derivative
or analog thereof in an amount suitable to support and/or enhance
at least one of: bile levels, biliary cholesterol levels, bile
saturation index, antioxidation, detoxification pathways,
inflammation alleviation and protein synthesis.
[0102] Taurine also known as 2-aminoethanesulfonic acid: In some
embodiment the source of taurine is L-taurine. Certain methods and
formulations described herein comprise a suitable amount of taurine
or derivative or analog thereof. In certain embodiments, methods
and formulations of dietary supplements comprise taurine or
derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: obesity management, blood sugar
metabolism, heart health, life-span improvements, eyes and ears
health, liver health, cardiovascular system, insulin action,
antioxidation, calcium, magnesium, potassium, sodium, blood
pressure, platelet activity, bile acids and cholesterol.
[0103] Choline: In some embodiments, the source of choline is
choline bitartrate. Certain methods and formulations described
herein comprise a suitable amount of choline or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise choline or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: liver function, moods, memory, endurance, and cholesterol
levels.
[0104] Betaine Hydrochloride: Certain methods and formulations
described herein comprise a suitable amount of betaine
hydrochloride or derivative or analog thereof. In certain
embodiments, methods and formulations of dietary supplements
comprise betaine hydrochloride or derivative or analog thereof in
an amount suitable to support and/or enhance at least one of:
digestion and gall bladder function.
[0105] Marshmallow root: Certain methods and formulations described
herein comprise a suitable amount of marshmallow root or extract or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise marshmallow root or
extract or derivative or analog thereof in an amount suitable to
support and/or enhance at least one of: inflammation alleviation,
intestinal and digestive health.
[0106] Curcumin: Certain methods and formulations described herein
comprise a suitable amount of curcumin or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise curcumin or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: inflammation response, antioxidation, liver and brain
health, immune system, dopanergic neurons and neuro-protection
[0107] L-glutamine: Certain methods and formulations described
herein comprise a suitable amount of L-glutamine or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise L-glutamine or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: sulfation, methylation, detoxification, glutathione
storage, oxidative stress management and small intestine
health.
[0108] N-Acetyl-L-Cysteine: Certain methods and formulations
described herein comprise a suitable amount of N-Acetyl-L-Cystine
or derivative or analog thereof. In certain embodiments, methods
and formulations of dietary supplements comprise N-Acetyl-L-Cystine
or derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: glutathione level management, gene
expression, inflammation alleviation, antioxidation and insulin
receptor site sensitivity.
[0109] Ginger root: Certain methods and formulations described
herein comprise a suitable amount of ginger root or extract or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise ginger root or extract
or derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: bile secretion, liver cholesterol
levels, inflammation alleviation, blood sugar metabolism,
cholesterol management, insulin levels, insulin sensitivity,
digestion, heart health, and weight management.
[0110] Bromelain: Certain methods and formulations described herein
comprise a suitable amount of bromelian or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise bromelain or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: digestion, inflammation alleviation, recovery time, and
joint health
[0111] Methyl sulfonyl methane (MSM): Certain methods and
formulations described herein comprise a suitable amount of MSM or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise MSM or derivative or
analog thereof in an amount suitable to support and/or enhance at
least one of: inflammation alleviation, sulfation and liver-gut
axis health.
[0112] S-Adenosyl Methionine (sam-E): Certain methods and
formulations described herein comprise a suitable amount of sam-E
or derivative or analog thereof. In certain embodiments, methods
and formulations of dietary supplements comprise sam-E or
derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: mood stabilization, brain, liver,
joints support.
[0113] Dandelion root: Certain methods and formulations described
herein comprise a suitable amount of dandelion root or extract or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise dandelion root or
extract or derivative or analog thereof in an amount suitable to
support and/or enhance at least one of: liver, gall bladder, bile
function, digestion and cholesterol level.
[0114] Lecithin: Certain methods and formulations described herein
comprise a suitable amount of lecithin or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise lecithin or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: biliary system, lipids, nervous system, circulatory system,
metabolism, heart health, and memory.
[0115] Beet root: Certain methods and formulations described herein
comprise a suitable amount of beet root or extract or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise beet root or extract or derivative or
analog thereof in an amount suitable to support and/or enhance at
least one of: blood pressure, stamina, inflammation management, and
detoxification.
[0116] Superoxide Dismutase: Certain methods and formulations
described herein comprise a suitable amount of superoxide dismutase
or derivative or analog thereof. In certain embodiments, methods
and formulations of dietary supplements comprise superoxide
dismutase or derivative or analog thereof in an amount suitable to
support and/or enhance at least one of: antioxidation, and
inflammation management.
[0117] Sarsparilla root: Certain methods and formulations described
herein comprise a suitable amount of sarsparilla root or extract or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise sarsparilla root or
extract or derivative or analog thereof in an amount suitable to
support and/or enhance at least one of: skin, kidney,
detoxification and inflammation alleviation.
[0118] DL-Methionine: Certain methods and formulations described
herein comprise a suitable amount of DL-methionine or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise DL-methionine or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: liver, breakdown of fats and antioxidation.
[0119] Gotu Kola: Certain methods and formulations described herein
optionally comprise a suitable amount of gotu kola or extract or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise gota kola or extract
or derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: detoxification, liver and venous
system health.
[0120] L-glutathione: Certain methods and formulations described
herein comprise a suitable amount of L-glutathione or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise L-glutathione or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: heart functioning and health, cardiovascular system,
detoxification, liver health, mood stabilization, respiratory
system, antioxidation, and inflammation alleviation.
[0121] L-Glycine: Certain methods and formulations described herein
comprise a suitable amount of L-glycine or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise L-glycine or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: production of nucleic acids, bile acids, creatine
phosphate; breakdown of fats; heme production; mood stabilization;
blood sugar metabolism; muscle growth; hormones and heart
health.
[0122] Watercress Leaf: Certain methods and formulations described
herein comprise a suitable amount of watercress leaf or extract or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise watercress leaf or
extract or derivative or analog thereof in an amount suitable to
support and/or enhance at least one of: antioxidation and DNA
against damage.
[0123] Banaba Leaf: Certain methods and formulations described
herein comprise a suitable amount of banaba leaf or extract or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise banaba leaf or extract
or derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: blood sugar metabolism, peripheral
glucose utilization, weight control, cholesterol maintenance,
insulin sensitivity, cellular uptake of glucose, triglyceride
levels, antioxidation, inflammation response and bone health.
[0124] Berberine Hydrochloride: Certain methods and formulations
described herein comprise a suitable amount of berberine
hydrochloride or derivative or analog thereof. In certain
embodiments, methods and formulations of dietary supplements
comprise berberine hydrochloride or derivative or analog thereof in
an amount suitable to support and/or enhance at least one of: blood
sugar metabolism, weight management, cholesterol, triglycerides,
cognitive function, heart health, cardiovascular, cartilage and
bone health, neuroprotection, inflammation alleviation and
intestinal health.
[0125] Bitter Melon: Certain methods and formulations described
herein comprise a suitable amount of bitter melon or extract or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise bitter melon or
extract or derivative or analog thereof in an amount suitable to
support and/or enhance at least one of: blood sugar
levels/metabolism, cholesterol and weight management,
triglycerides, antioxidation and digestion.
[0126] Citrimax: Certain methods and formulations described herein
comprise a suitable amount of citrimax or extract or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise citrimax or extract or derivative or
analog thereof in an amount suitable to support and/or enhance at
least one of: weight loss and appetite control.
[0127] Guggul: Certain methods and formulations described herein
comprise a suitable amount of guggul or extract or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise guggul or extract or derivative or
analog thereof in an amount suitable to support and/or enhance at
least one of: blood sugar levels/metabolism, cholesterol and weight
management, triglycerides, antioxidation and digestion, thyroid
health, LDL levels, lipid peroxidation and cholesterol
maintenance.
[0128] Poria Cocos Root: Certain methods and formulations described
herein comprise a suitable amount of poria cocos root or extract or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise poria cocos root or
extract or derivative or analog thereof in an amount suitable to
support and/or enhance at least one of: inflammation alleviation,
gastrointestinal health, mood stabilization, water retention
(diuretic), and central nervous system maintenance.
[0129] Rehmannia Glutinosa or Chinese Foxglove: Certain methods and
formulations described herein comprise a suitable amount of
rehmannia glutinosa or extract or derivative or analog thereof. In
certain embodiments, methods and formulations of dietary
supplements comprise rehmannia glutinosa or extract or derivative
or analog thereof in an amount suitable to support and/or enhance
at least one of: inflammation alleviation, blood sugar metabolism,
red blood cell formation, kidneys, and energy.
[0130] Broad Bean: Certain methods and formulations described
herein optionally comprise a suitable amount of broad bean or
extract or derivative or analog thereof. In certain embodiments,
methods and formulations of dietary supplements comprise broad bean
or extract or derivative or analog thereof in an amount suitable to
support and/or enhance at least one of: antioxidation support,
dopamine, and cholesterol maintenance.
[0131] Inositol or cyclohexane-1,2,3,4,5,6-hexol: Certain methods
and formulations described herein comprise a suitable amount of
inositol or derivative or analog thereof. In certain embodiments,
methods and formulations of dietary supplements comprise inositol
or derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: neuroprotection, hair health,
cholesterol stabilization, mood stabilization, blood sugar
metabolism, and digestion.
[0132] L-Carnitine tartrate: Certain methods and formulations
described herein comprise a suitable amount of L-carnitine tartrate
or derivative or analog thereof. In certain embodiments, methods
and formulations of dietary supplements comprise L-carnitine
tartrate or derivative or analog thereof in an amount suitable to
support and/or enhance at least one of: heart health,
cardiovascular system, fat burning, brain, fatty liver alleviation,
insulin sensitivity, blood sugar metabolism, neuroprotection and
cholesterol maintenance.
[0133] Para-aminobenzoic acid (PABA): Certain methods and
formulations described herein comprise a suitable amount of PABA or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise PABA or derivative or
analog thereof in an amount suitable to support and/or enhance at
least one of: antioxidation and utilization of B5.
[0134] Asiatic Dogwood Fruit: Certain methods and formulations
described herein comprise a suitable amount of asiatic dogwood
fruit or extract or derivative or analog thereof. In certain
embodiments, methods and formulations of dietary supplements
comprise asiatic dogwood fruit or extract or derivative or analog
thereof in an amount suitable to support and/or enhance at least
one of: inflammation control, antioxidation, cholesterol
maintenance, liver and kidney health, cardiovascular health,
menstruation, immune system regulation and blood sugar
metabolism.
[0135] Cordyceps: Certain methods and formulations described herein
comprise a suitable amount of cordyceps or extract or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise cordyceps or extract or derivative or
analog thereof in an amount suitable to support and/or enhance at
least one of: cholesterol stabilization, cellular repair, DNA
repair, liver and kidney health, immune system health,
antioxidation and energy.
[0136] Maca also known as Peruvian Ginseng: Certain methods and
formulations described herein comprise a suitable amount of maca or
extract or derivative or analog thereof. In certain embodiments,
methods and formulations of dietary supplements comprise maca or
extract or derivative or analog thereof in an amount suitable to
support and/or enhance at least one of: stress management, and mood
stabilization.
[0137] Suma root: Certain methods and formulations described herein
comprise a suitable amount of suma root or extract or derivative or
analog thereof. In certain embodiments, methods and formulations of
dietary supplements comprise suma root or extract or derivative or
analog thereof in an amount suitable to support and/or enhance at
least one of: blood sugar metabolism, adaptogenic/stress, adrenal
glands, hormones, blood sugar metabolism, energy, heart health and
inflammation alleviation.
[0138] Aswagandha Root, also known as Withania somnifera: Certain
methods and formulations described herein comprise a suitable
amount of aswagandha root or extract or derivative or analog
thereof. In certain embodiments, methods and formulations of
dietary supplements comprise aswagandha root or extract or
derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: stress reduction, adrenal glands
function, liver, antioxidation, thyroid and healthy cortisol
levels.
[0139] Rhodiola Rosea: Certain methods and formulations described
herein comprise a suitable amount of rhodiola rosea or extract or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise rhodiola rosea or
extract or derivative or analog thereof in an amount suitable to
support and/or enhance at least one of: central nervous system,
mood stabilization, heart health, cardiovascular health, healthy
stress response, immune system, cognitive function, and mental
energy.
[0140] Eleutherococcus Senticosus: Certain methods and formulations
described herein comprise a suitable amount of eleutherococcus
senticosus or extract or derivative or analog thereof. In certain
embodiments, methods and formulations of dietary supplements
comprise eleutherococcus senticosus or extract or derivative or
analog thereof in an amount suitable to support and/or enhance at
least one of: stress management, energy, LDL cholesterol, and
adrenal feedback loop.
[0141] Pantethine: Certain methods and formulations described
herein comprise a suitable amount of pantethine or extract or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise pantetheine or extract
or derivative or analog thereof in an amount suitable to support
and/or enhance at least one of: adrenals, adrenal hormones, stress,
and cortisol.
[0142] Salacia oblonga: Certain methods and formulations described
herein comprise a suitable amount of salacia oblonga or extract or
derivative or analog thereof. In certain embodiments, methods and
formulations of dietary supplements comprise salacia oblonga or
extract or derivative or analog thereof in an amount suitable to
support and/or enhance at least one of: blood sugar metabolism,
joint health, menstruation, and weight management.
[0143] Phosphatidyl Serine: Certain methods and formulations
described herein comprise a suitable amount of phosphatidyl serine
or derivative or analog thereof. In certain embodiments, methods
and formulations of dietary supplements comprise phosphatidyl
serine or derivative or analog thereof in an amount suitable to
support and/or enhance at least one of: cellular chemical
signaling, brain health, hippocampus function, stress alleviation,
HPA axis, cortisol levels, and sleep.
[0144] Eicosapentaenoic acid and Docosahexaenoic acid (EPA/DHA):
Certain methods and formulations described herein comprise a
suitable amount of EPA/DHA or derivative or analog thereof. In
certain embodiments, methods and formulations of dietary
supplements comprise EPA/DHA or derivative or analog thereof in an
amount suitable to support and/or enhance at least one of:
inflammation alleviation, heart health, cardiovascular health,
immune system regulation, liver health, hormones, brain health,
cells, adrenal glands, cholesterol management, blood pressure
management, and insulin sensitivity.
[0145] Exemplary Formulations
[0146] Provided herein are formulations useful for treatment and
stabilization of individuals suffering from type II diabetes or at
risk of developing type II diabetes.
[0147] Provided herein is a formulation comprising: group A
components consisting essentially of protein selected from pea
protein isolate, sacha inchi protein, hemp protein, rice protein,
artichoke protein, chia seed protein, beef protein or combinations
thereof, at least one group B component that comprises dandelion
extract, milk thistle extract, phospholipids, ginger, taurine,
turmeric extract, vitamin C, methionine or combinations thereof, at
least one group C component that comprises magnesium,
trimethylglycine, glutathione, N-acetyl-cysteine, glutamine, alpha
lipoic acid, glycine or combinations thereof; at least one group D
component that comprises hesperidin, beet root, enzyme blend,
sarsparilla root, bromelain, betaine, methylsulfonylmethane (MSM),
choline bitartarate, primrose, inulin, watercress leaf, Panax
ginseng root extract, selenium, lecithin, or S-anenosylmethionine
(SAM-e), thiamine, vitamin B5, niacin, vitamin E, riboflavin,
vitamin B6, folate, vitamin B12, biotin, zinc, copper, molybdenum,
carotene, calcium, vitamin D, sodium phosphate, vitamin A, calcium,
phosphorus, chromium, triglyceride, quercetin, rutin, Marshmallow
extract, Jerusalem artichoke tuber, fiber or combinations thereof,
and an excipient. In some embodiments, the enzyme blend comprises a
lactase, a cellulase, a protease, a lipase, a dismutase, a
catalase, or a combination thereof.
[0148] Provided herein are formulations useful for treatment and/or
stabilization of individuals suffering from type II diabetes or at
risk of developing type II diabetes. In some embodiments, provided
is a formulation comprising: group A components consisting
essentially of protein selected from pea protein isolate, sacha
inchi protein, hemp protein, rice protein, artichoke protein, chia
seed protein, beef protein or combinations thereof; at least one
group B component that comprises dandelion extract, milk thistle
extract, phospholipids, ginger, taurine, turmeric extract, vitamin
C, methionine or combinations thereof; at least one group C
component that comprises magnesium, trimethylglycine, glutathione,
N-acetyl-cysteine, Cordyceps sinensis extract, glutamine, alpha
lipoic acid, glycine or combinations thereof; and an excipient. In
some embodiments, the formulation further comprises pea protein
isolate and sacha inchi protein. In some embodiments, the
formulation further comprises a protein derived from a source which
is not pea protein isolate. In some embodiments, the formulation
further comprises a protein derived from a source which is not
sacha inchi protein.
[0149] Further provided is a formulation comprising: group A
components consisting essentially of maca, Cornus officinalis fruit
extract or combinations thereof at least one group B component that
comprises berberine, bitter melon extract, Gymnema sylvestre leaf
extract, banaba, carnitine or combinations thereof; at least one
group C component that comprises vitamin C, Panax ginseng root
extract, Aswagandha root extract, holy basil leaf extract, Rhodiola
rosea extract, Eleutherococcus senticosus extract, vitamin B5,
cactus stem extract, phosphatidylserine, vitamin D or combinations
thereof; and an excipient. In some embodiments, the formulation
further comprises a fish oil formulation. The fish oil formulation
may comprise omega-3 at a range of about 15% to about 100%.
[0150] Also provided is a formulation comprising: group A
components consisting essentially of maca, Cornus officinalis fruit
extract or combinations thereof; at least one group B component
that comprises berberine, bitter melon extract, Gymnema sylvestre
leaf extract, banaba, or carnitine; at least one group C component
that comprises vitamin C, Panax ginseng root extract, Aswagandha
root extract, holy basil leaf extract, Rhodiola rosea extract,
Eleutherococcus senticosus extract, vitamin B5, cactus stem
extract, phosphatidylserine, vitamin D or combinations thereof; at
least one group D component that comprises Cordyceps sinesis
extract, Gingko biloba leaf extract, suma root, Garcinia cambogia
extract, Rehmannia glutinosa extract, Poria cocos root extract,
cinnamon extract, Fenugreek, Guggul, citrimax extract, salacia
oblonga extract, vitamin E, thiamin, riboflavin, niacin, vitamin
B6, folate, vitamin B12, biotin, magnesium, zinc, selenium,
manganese, chromium, vanadium, zinc, biotin, alpha lipoic acid,
N-acetyl-cysteine, 4-aminobenzoic acid (PABA), choline bitartrate,
glutamine, glutathione, protein, fiber, inositol or combinations
thereof; and an excipient.
[0151] Still further provided is a formulation comprising: group A
components consisting essentially of cactus stem extract; at least
one group B component that comprises berberine, bitter melon
extract, Gymnema sylvestre leaf extract, banaba, carnitine or
combinations thereof; at least one group C component that comprises
Garcinia cambogia extract, Rehmannia glutinosa extract, Poria cocos
root extract, cinnamon extract, Fenugreek, Guggul, Vitamin D or
combinations thereof; and an excipient.
[0152] Additionally provided is a formulation comprising: group A
component comprising cactus stem extract; at least one of group B
component that comprises berberine, bitter melon extract, Gymnema
sylvestre leaf extract, banaba, carnitine or combinations thereof;
at least one group C component that comprises Garcinia cambogia
extract, Rehmannia glutinosa extract, Poria cocos root extract,
cinnamon extract, Fenugreek, or Guggul; at least one group D
component that comprises vitamin D, vitamin E, thiamin, riboflavin,
niacin, vitamin B6, folate, vitamin B12, biotin, vitamin B5,
magnesium, zinc, selenium, manganese, chromium, vanadium, alpha
lipoic acid, N-acetyl-cysteine, 4-aminobenzoic acid (PABA), choline
bitartarate, citrimax extract, taurine, coenzyme Q10, calcium,
vitamin K2, vitamin C, protein, fiber, inositol or combinations
thereof; and an excipient.
[0153] In some embodiments, is a formulation comprising: group A
components consisting essentially of at least one protein
optionally selected from a list comprising pea protein isolate and
sacha inchi protein; at least one group B component that comprises
dandelion extract, milk thistle extract, phospholipids, ginger,
taurine, turmeric extract, vitamin C, or methionine; at least one
group C component that comprises magnesium, trimethylglycine,
glutathione, N-acetyl-cysteine, Cordyceps sinensis extract,
glutamine, alpha lipoic acid, or glycine; and an excipient. In some
embodiments, the formulation further comprises pea protein isolate
and sacha inchi protein. In some embodiments, the formulation
further comprises a protein derived from a source which is not pea
protein isolate. In some embodiments, the formulation further
comprises a protein derived from a source which is not sacha inchi
protein. Provided is a formulation comprising: group A components
consisting essentially of at least one protein optionally selected
from a list comprising pea protein isolate and sacha inchi protein;
at least one group B component that comprises about 5% to about 40%
by weight of dandelion extract, about 3% to about 15% by weight of
milk thistle extract, about 1% to about 12% by weight of
phospholipids, about 1% to about 10% by weight of ginger, about
0.5% to about 8% by weight of taurine, about 0.5% to about 8% by
weight of turmeric extract, about 1% to about 8% by weight of
vitamin C, or about 1% to about 11% by weight of methionine; at
least one group C component that comprises about 10% to about 55%
by weight of magnesium, about 1% to about 40% by weight of
trimethylglycine, about 0.5% to about 35% by weight of glutathione,
about 0.5% to about 30% by weight of N-acetyl-cysteine, about 0.5%
to about 6% by weight of Cordyceps sinensis extract, about 0.5% to
about 6% by weight of glutamine, about 0.5% to about 6% by weight
of alpha lipoic acid, or about 0.5% to about 60% by weight of
glycine; and an excipient. In some embodiments, a formulation
described herein is administered to the subject between about 2 and
about 60 days. In some embodiments, the formulation is administered
for about 10, 15, 20, 30, 40, 45, 50, or 60 days. In certain
further embodiments, the formulation is administered for about 30
days. In some additional embodiments, a formulation described
herein may be administered at fixed intervals during administration
of a second formulation described herein. The fixed interval may be
between about two and about four months. In some embodiments, the
fixed interval is about three months.
[0154] Provided is a formulation comprising: group A components
consisting essentially of maca, Cornus officinalis fruit extract,
and optionally broad bean; at least one group B component that
comprises berberine, bitter melon extract, Gymnema sylvestre leaf
extract, banaba, or carnitine; at least one group C component that
comprises vitamin C, Panax ginseng root extract, Aswagandha root
extract, holy basil leaf extract, Rhodiola rosea extract,
Eleutherococcus senticosus extract, vitamin B5, cactus stem
extract, phosphatidylserine, or vitamin D; and an excipient. In
some embodiments, the formulation further comprises a fish oil
formulation. The fish oil formulation may comprise omega-3 at a
range of about 15% to about 100%. The fish oil formulation may also
comprise eicosapentaenoic acid (EPA) at a range of about 5% to
about 100%. In some embodiments, the fish oil formulation comprises
docosahexaenoic acid (DHA) at a range of about 10% to about 100%.
In certain embodiments, a formulation described herein is provided
to a subject for a period of time which is from about one month to
about sixty months. In some embodiments, the period of time may be
from about six months to about thirty six months. In some cases,
this period of time is from about twelve months to about twenty
four months. In certain cases, the period of time is the time
required for the subject to achieve a predetermined change in blood
sugar level. In an embodiment, the period of time is the time
required for the subject to achieve a predetermined reduction in
hemoglobin A1C level.
[0155] Provided is a formulation comprising: group A components
consisting essentially of maca, Cornus officinalis fruit extract,
and optionally broad bean; at least one group B component that
comprises about 6% to about 18% by weight of berberine, about 0.2%
to about 18% by weight of bitter melon extract, about 8% to about
18% by weight of Gymnema sylvestre leaf extract, about 0.2% to
about 18% by weight of banaba, or about 1% to about 5% by weight of
carnitine; at least one group C component that comprises about 2%
to about 9% by weight of vitamin C, about 5% to about 21% by weight
of Panax ginseng root extract, about 4% to about 16% by weight of
Aswagandha root extract, about 3% to about 13% by weight of holy
basil leaf extract, about 2% to about 10% by weight of Rhodiola
rosea extract, about 1% to about 7% by weight of Eleutherococcus
senticosus extract, about 1% to about 7% by weight vitamin B5,
about 1% to about 8% by weight of cactus stem extract, about 20% to
about 90% by weight of phosphatidylserine, or vitamin D; and an
excipient. In some embodiments, the formulation further comprises a
fish oil formulation. The fish oil formulation may comprise omega-3
at a range of about 15% to about 100%. The fish oil formulation may
also comprise eicosapentaenoic acid (EPA) at a range of about 5% to
about 100%. In some embodiments, the fish oil formulation comprises
docosahexaenoic acid (DHA) at a range of about 10% to about
100%.
[0156] Provided is a formulation comprising: group A components
consisting essentially of cactus stem extract and optionally broad
bean; at least one group B component that comprises berberine,
bitter melon extract, Gymnema sylvestre leaf extract, banaba, or
carnitine; at least one group C component that comprises Garcinia
cambogia extract, Rehmannia glutinosa extract, Poria cocos root
extract, cinnamon extract, Fenugreek, Guggul, or Vitamin D; and an
excipient. In some embodiments is provided a formulation
comprising: group A components cactus stem extract and optionally
broad bean; group B components comprising one or more of about 6%
to about 28% by weight of berberine, about 0.2% to about 18% by
weight of bitter melon extract, about 8% to about 18% by weight of
Gymnema sylvestre leaf extract, about 0.2% to about 18% by weight
of banaba, and about 2% to about 5% by weight of carnitine; group C
components comprising one or more of Garcinia cambogia extract,
Rehmannia glutinosa extract, Poria cocos root extract, cinnamon
extract, Fenugreek, and Guggul, wherein the concentration of each
of the group C components is from about 0.2% to about 0.6% by
weight; vitamin D; and an excipient. In certain cases, the
formulation is provided to a subject for a period of time which is
from about 1 month to about the remaining lifetime of the
subject.
[0157] In some embodiments is a formulation described herein,
wherein dandelion extract is dandelion root extract. In some
embodiments is a formulation described herein, wherein the
phospholipids comprise about 40% phosphatidylcholine. In some
embodiments is a formulation described herein, wherein the turmeric
extract comprises about 95% curcumin. In some embodiments is a
formulation described herein, wherein milk thistle extract is milk
thistle seed extract comprises about 80% silymarin. In some
embodiments is a formulation described herein, optionally further
comprising a gotu kola extract, which is optionally a gotu kola
leaf extract. In some embodiments is a formulation described
herein, wherein vitamin C comprises L-ascorbic acid, calcium
ascorbate, or a combination thereof. In some embodiments is a
formulation described herein, wherein magnesium is magnesium
citrate. In some embodiments is a formulation described herein,
wherein glutathione comprises L-glutathione, S-acetyl
L-glutathione, or a combination thereof. In some embodiments is a
formulation described herein, wherein N-acetyl-cysteine is N-Acetyl
L-cysteine. In some embodiments is a formulation described herein,
wherein Cordyceps sinensis extract comprises about 7% cordycepic
acid. In some embodiments is a formulation described herein,
wherein glutamine is L-glutamine. In some embodiments is a
formulation described herein, wherein alpha lipoic acid is alpha
R-lipoic acid. In some embodiments is a formulation described
herein, wherein glycine is L-glycine. In some embodiments is a
formulation described herein, further comprising at least one group
D component that comprises hesperidin, beet root, enzyme blend,
sarsaparilla root, bromelain, betaine, methylsulfonylmethane (MSM),
choline bitartarate, luo han guo, stevia extract rebaudioside,
primrose, inulin, watercress leaf, Panax ginseng root extract,
selenium, or S-anenosylmethionine (SAM-e). In some embodiments is a
formulation described herein, wherein luo han guo comprises about
40% mogrosides. In some embodiments is a formulation described
herein, wherein the stevia extract rebaudioside is stevia extract
97% rebaudioside. In some embodiments is a formulation described
herein, wherein the primrose is evening primrose oil powder. In
some embodiments is a formulation described herein, wherein
hesperidin is hesperidin complex. In some embodiments is a
formulation described herein, wherein beet root is beet root
powder. In some embodiments is a formulation described herein,
wherein the enzyme blend comprises a lactase, a cellulase, a
protease, a lipase, a dismutase, a catalase, or a combination
thereof. In some embodiments is a formulation described herein,
wherein betaine is betaine hydrochloride. In some embodiments is a
formulation described herein, wherein choline is choline
bitartarate. In some embodiments is a formulation described herein,
wherein the watercress leaf is watercress leaf powder. In some
embodiments is a formulation described herein, wherein selenium is
L-selenomethionine. In some embodiments is a formulation described
herein, further comprising at least one group E component that
comprises thiamine, vitamin B5, niacin, vitamin E, vitamin B6,
folate, vitamin B12, biotin, zinc, copper, molybdenum, carotene,
calcium, vitamin D, sodium phosphate, triglyceride, quercetin,
rutin, Marshmallow extract, or Jerusalem artichoke tuber.
[0158] In some embodiments is a formulation described herein,
wherein thiamine is optionally benfotiamine. In some embodiments is
a formulation described herein, wherein vitamin B5 comprises at
least one of pantothenic acid, pantethine, d-calcium pantothenate,
or a combination thereof. In some embodiments is a formulation
described herein, wherein niacin comprises at least one of
niacinamide, nicotinic acid, or a combination thereof. In some
embodiments is a formulation described herein, wherein vitamin E is
d-alpha tocopherol succinate. In some embodiments is a formulation
described herein, optionally further comprising riboflavin, wherein
said riboflavin is optionally riboflavin-5'-phosphate. In some
embodiments is a formulation described herein, wherein vitamin B6
comprises at least one of pyridoxal-5-phosphate, pyridoxine HCl, or
a combination thereof. In some embodiments is a formulation
described herein, wherein folate is L-5-methyltetrahydrofolate.
[0159] In some embodiments is a formulation described herein,
wherein vitamin B12 is methylcobalamin. In some embodiments is a
formulation described herein, wherein zinc is zinc glycinate. In
some embodiments is a formulation described herein, wherein copper
is copper gluconate. In some embodiments is a formulation described
herein, wherein molybdenum is molybdenum amino acid chelate. In
some embodiments is a formulation described herein, wherein
carotene is beta carotene. In some embodiments is a formulation
described herein, wherein calcium is calcium ascorbate. In some
embodiments is a formulation described herein, wherein vitamin D is
vitamin D3. In some embodiments is a formulation described herein,
wherein sodium phosphate is disodium phosphate. In some embodiments
is a formulation described herein, wherein the triglyceride is a
triglyceride comprising about 6-12 carbon fatty acid esters.
[0160] In some embodiments is a formulation described herein,
wherein quercetin is quercetin dihydrate. In some embodiments is a
formulation described herein, wherein Marshmallow extract is
Marshmallow root extract. In some embodiments is a formulation
described herein, wherein the concentration of pea protein isolate
in the formulation is from about 5% to about 70% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of sacha inchi protein in the formulation is from
about 0.5% to about 10% by weight. In some embodiments is a
formulation described herein, wherein the concentration of
dandelion extract in the formulation is from about 5% to about 40%
by weight. In some embodiments is a formulation described herein,
wherein the concentration of milk thistle extract in the
formulation is from about 3% to about 15% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of phospholipids in the formulation is from about 1%
to about 12% by weight. In some embodiments is a formulation
described herein, wherein the concentration of ginger in the
formulation is from about 1% to about 10% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of taurine in the formulation is from about 0.5% to
about 8% by weight.
[0161] In some embodiments is a formulation described herein,
wherein the concentration of turmeric extract in the formulation is
from about 0.5% to about 8% by weight. In some embodiments is a
formulation described herein, wherein the optionally comprising
gotu kola extract in a concentration up to about 8% by weight. In
some embodiments is a formulation described herein, wherein the
concentration of vitamin C in the formulation is from about 1% to
about 8% by weight. In some embodiments is a formulation described
herein, wherein the concentration of methionine in the formulation
is from about 1% to about 11% by weight. In some embodiments is a
formulation described herein, wherein the concentration of
magnesium in the formulation is from about 10% to about 55% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of trimethylglycine in the formulation is
from about 1% to about 40% by weight. In some embodiments is a
formulation described herein, wherein the concentration of
glutathione in the formulation is from about 0.5% to about 35% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of N-acetyl-cysteine in the formulation
is from about 0.5% to about 30% by weight. In some embodiments is a
formulation described herein, wherein the concentration of
Cordyceps sinensis extract in the formulation is from about 0.5% to
about 6% by weight. In some embodiments is a formulation described
herein, wherein the concentration of glutamine in the formulation
is from about 0.5% to about 6% by weight. In some embodiments is a
formulation described herein, wherein the concentration of alpha
lipoic acid in the formulation is from about 0.5% to about 6% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of glycine in the formulation is from
about 0.5% to about 6% by weight.
[0162] In some embodiments is a formulation described herein,
wherein the excipient comprises gelatin, cellulose, medium-chain
triglyceride (MCT) oil, silicon dioxide, stearic acid, xanthan gum,
potassium sorbate, turmeric powder, primrose oil, lemon oil, or
combinations thereof. In some embodiments is a formulation
described herein, wherein the formulation is in a powder form, a
semi-solid form, a liquid form, an emulsion form, or a combination
thereof.
[0163] In some embodiments is a formulation described herein,
further comprising at least one component that comprises
hesperidin, beet root, enzyme blend, sarsaparilla root, bromelain,
betaine, methylsulfonylmethane (MSM), choline bitartarate, luo han
guo, stevia extract rebaudioside, primrose, inulin, watercress
leaf, Panax ginseng root extract, selenium, or S-anenosylmethionine
(SAM-e). In some embodiments is a formulation described herein,
further comprising at least one component that comprises thiamine,
vitamin B5, niacin, vitamin E, riboflavin, vitamin B6, folate,
vitamin B12, biotin, zinc, copper, molybdenum, carotene, calcium,
vitamin D, sodium phosphate, triglyceride, quercetin, rutin,
Marshmallow extract, or Jerusalem artichoke tuber. In some
embodiments is a formulation described herein, wherein the
phospholipids comprise about 40% phosphatidylcholine. In some
embodiments is a formulation described herein, wherein the turmeric
extract comprises about 95% curcumin. In some embodiments is a
formulation described herein, wherein milk thistle extract is milk
thistle seed extract comprising about 80% silymarin.
[0164] In some embodiments is a formulation described herein,
further comprising gotu kola extract, wherein optionally said gotu
kola extract is gotu kola leaf extract. In some embodiments is a
formulation described herein, wherein vitamin C comprises
L-ascorbic acid, calcium ascorbate, or a combination thereof. In
some embodiments is a formulation described herein, wherein
glutathione comprises L-glutathione, S-acetyl L-glutathione, or a
combination thereof. In some embodiments is a formulation described
herein, wherein Cordyceps sinensis extract comprises about 7%
cordycepic acid. In some embodiments is a formulation described
herein, wherein luo han guo comprises about 40% mogrosides.
[0165] In some embodiments is a formulation described herein,
wherein the stevia extract rebaudioside is stevia extract 97%
rebaudioside. In some embodiments is a formulation described
herein, wherein the concentration of pea protein isolate in the
formulation is from about 5% to about 70% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of sacha inchi protein in the formulation is from
about 0.5% to about 10% by weight.
[0166] In an embodiment is a formulation described herein, wherein
berberine is berberine hydrochloride. In some embodiments is a
formulation described herein, wherein carnitine is carnitine
tartrate. In some embodiments is a formulation described herein,
wherein carnitine is L-carnitine L-tartrate. In some embodiments is
a formulation described herein, wherein the Cordyceps sinesis
extract is a Cordyceps sinesis mycelium extract. In some
embodiments is a formulation described herein, wherein vitamin C is
L-ascorbic acid. In some embodiments is a formulation described
herein, wherein vitamin B5 comprises at least one of pantothenic
acid, pantethine, d-calcium pantothenate, or a combination thereof.
In some embodiments is a formulation described herein, wherein the
phosphatidylserine is a phospholipid complex supplement. In an
embodiment is a formulation described herein, wherein vitamin D is
a powder. In some embodiments is a formulation described herein,
further comprising at least one component that comprises Cordyceps
sinesis extract, Gingko biloba leaf extract, suma root, Garcinia
cambogia extract, Rehmannia glutinosa extract, Poria cocos root
extract, cinnamon extract, Fenugreek, or Guggul.
[0167] In some embodiments is a formulation described herein,
wherein Rehmannia glutinosa extract is Rehmania glutinosa rhizome
extract. In some embodiments is a formulation described herein,
wherein the Rehmania glutinosa rhizome extract is a Rehmania
glutinosa rhizome 5:1 extract.
[0168] In some embodiments is a formulation described herein,
further comprising a fish oil formulation. In some embodiments is a
formulation described herein, wherein the fish oil formulation
comprises omega-3 at a range of about 15% to about 100%. In some
embodiments is a formulation described herein, wherein the fish oil
formulation comprises eicosapentaenoic acid (EPA) at a range of
about 5% to about 100%. In some embodiments the fish oil
formulation comprises docosahexaenoic acid (DHA) at a range of
about 10% to about 100%. In some embodiments is a formulation
described herein, wherein the fish oil formulation is in a powder
form. In some embodiments is a formulation described herein,
wherein the fish oil formulation is in a liquid form. In some
embodiments is a formulation described herein, wherein the fish oil
formulation is in an emulsion form. In some embodiments is a
formulation described herein, wherein the fish oil formulation
further comprises one or more of citric acid, luo han guo, sodium
citrate, calcium glycinate amino acid complex, magnesium glycinate,
zinc glycinate chelate, zinc L-monomethionine,
pyridoxal-5-phosphate drum, niacin, molybdenum amino acid chelate,
taurine, lecithin, glycerine, and vitamin E.
[0169] In some embodiments is a formulation described herein,
further comprising at least one component that comprises one or
more of vitamin E, thiamin, riboflavin, niacin, vitamin B6, folate,
vitamin B12, biotin, magnesium, zinc, selenium, manganese,
chromium, vanadium, alpha lipoic acid, N-acetyl-cysteine,
4-aminobenzoic acid (PABA), choline bitartrate, or inositol. In
some embodiments is a formulation described herein, wherein the
concentration of berberine hydrochloride in the formulation is from
about 6% to about 28% by weight. In some embodiments is a
formulation described herein, wherein the concentration of bitter
melon extract in the formulation is from about 0.2% to about 18% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of Gymnema sylvestre leaf extract in the
formulation is from about 8% to about 18% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of banaba in the formulation is from about 0.2% to
about 18% by weight. In some embodiments is a formulation described
herein, wherein the concentration of cactus stem extract in the
formulation is from about 1% to about 8% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of L-carnitine L-tartrate in the formulation is from
about 1% to about 5% by weight. In some embodiments is a
formulation described herein, wherein the concentration of Garcinia
cambogia extract in the formulation is from about 0.1% to about 1%
by weight. In some embodiments is a formulation described herein,
wherein the concentration of Rehmannia glutinosa extract in the
formulation is from about 0.1% to about 3% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of Poria cocos root extract in the formulation is
from about 0.1% to about 1% by weight. In some embodiments is a
formulation described herein, wherein the concentration of cinnamon
extract in the formulation is from about 0.1% to about 1% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of Fenugreek extract in the formulation
is from about 0.1% to about 1% by weight.
[0170] In some embodiments is a formulation described herein,
wherein the concentration of Guggul extract in the formulation is
from about 0.1% to about 1% by weight. In some embodiments is a
formulation described herein, optionally comprising broad bean
extract which is optionally in a concentration from about 0.05% to
about 0.25% by weight. In some embodiments is a formulation
described herein, wherein the concentration of Cordyceps sinesis
extract in the formulation is from about 0.5% to about 3% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of maca in the formulation is from about
0.5% to about 3% by weight. In some embodiments is a formulation
described herein, wherein the concentration of Gingko biloba leaf
extract in the formulation is from about 0.5% to about 3% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of suma root extract in the formulation
is from about 0.5% to about 3% by weight. In some embodiments is a
formulation described herein, wherein the concentration of Cornus
officinalis fruit extract in the formulation is from about 0.5% to
about 3% by weight.
[0171] In some embodiments is a formulation described herein,
wherein the concentration of vitamin C in the formulation is from
about 2% to about 9% by weight. In some embodiments is a
formulation described herein, wherein the concentration of Panax
ginseng root extract in the formulation is from about 5% to about
21% by weight. In some embodiments is a formulation described
herein, wherein the concentration of Aswagandha root extract in the
formulation is from about 4% to about 16% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of holy basil leaf extract in the formulation is from
about 3% to about 13% by weight. In some embodiments is a
formulation described herein, wherein the concentration of Rhodiola
rosea extract in the formulation is from about 2% to about 10% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of Eleutherococcus senticosus extract in
the formulation is from about 1% to about 7% by weight.
[0172] In some embodiments is a formulation described herein,
wherein the concentration of vitamin B5 in the formulation is from
about 1% to about 7% by weight. In some embodiments is a
formulation described herein, wherein the concentration of
phosphatidylserine is from about 20% to about 90% by weight. In
some embodiments is a formulation described herein, wherein the
excipient comprises gelatin, cellulose, medium-chain triglyceride
(MCT) oil, silicon dioxide, stearic acid, or combinations
thereof.
[0173] In some embodiments is a formulation described herein,
optionally comprising broad bean. In some embodiments is a
formulation described herein, wherein berberine is berberine
hydrochloride. In some embodiments is a formulation described
herein, wherein carnitine is carnitine tartrate. In some
embodiments is a formulation described herein, wherein carnitine is
L-carnitine L-tartrate. In some embodiments is a formulation
described herein, wherein Rehmannia glutinosa extract is Rehmania
glutinosa rhizome extract. In some embodiments is a formulation
described herein, wherein the Rehmania glutinosa rhizome extract is
a Rehmania glutinosa rhizome 5:1 extract. In some embodiments is a
formulation described herein, wherein vitamin D is a powder. In
some embodiments is a formulation described herein, further
comprising at least one component that comprises vitamin E,
thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12,
biotin, vitamin B5, magnesium, zinc, selenium, manganese, chromium,
vanadium, alpha lipoic acid, N-acetyl-cysteine, 4-aminobenzoic acid
(PABA), choline bitartarate, or inositol. In some embodiments is a
formulation described herein, wherein vitamin E is d-alpha
tocopherol succinate. In some embodiments is a formulation
described herein, wherein thiamin is at least one of benfotiamine
and thiamine HCl. In some embodiments is a formulation described
herein, wherein riboflavin is roboflavin-5'-phosphate. In some
embodiments is a formulation described herein, wherein niacin
comprises at least one of niacinamide, nicotinic acid, or a
combination thereof. In some embodiments is a formulation described
herein, wherein vitamin B6 is at least one of pyridoxal-5-phosphate
and pyridoxine HCl. In some embodiments is a formulation described
herein, wherein folate is L-5-methyltetrahydrofolate.
[0174] In some embodiments is a formulation described herein,
wherein vitamin B12 is cyanocobalamin. In some embodiments is a
formulation described herein, wherein vitamin B5 comprises at least
one of pantothenic acid, d-calcium pantothenate, pantethine, or a
combination thereof. In some embodiments is a formulation described
herein, wherein magnesium is magnesium citrate.
[0175] In some embodiments is a formulation described herein,
wherein zinc is zinc glycinate. In some embodiments is a
formulation described herein, wherein selenium is
L-selenomethionine. In some embodiments is a formulation described
herein, wherein manganese is manganese gluconate. In some
embodiments is a formulation described herein, wherein chromium is
chromium niacin complex. In some embodiments is a formulation
described herein, wherein vanadium is vanadium sulfate. In some
embodiments is a formulation described herein, wherein alpha lipoic
acid is alpha R-lipoic acid. In some embodiments is a formulation
described herein, wherein N-acetyl-cysteine is N-Acetyl L-cysteine.
In some embodiments is a formulation described herein, wherein the
concentration of berberine hydrochloride in the formulation is from
about 6% to about 28% by weight. In some embodiments is a
formulation described herein, wherein the concentration of bitter
melon extract in the formulation is from about 0.2% to about 18% by
weight. In some embodiments is a formulation described herein,
wherein the concentration of Gymnema sylvestre leaf extract in the
formulation is from about 8% to about 18% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of banaba in the formulation is from about 0.2% to
about 18% by weight. In some embodiments is a formulation described
herein, wherein the concentration of cactus stem extract in the
formulation is from about 3% to about 8% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of L-carnitine L-tartrate in the formulation is from
about 2% to about 5% by weight.
[0176] In some embodiments is a formulation described herein,
wherein the concentration of Garcinia cambogia extract in the
formulation is from about 0.2% to about 0.6% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of Rehmannia glutinosa extract in the formulation is
from about 0.2% to about 0.6% by weight.
[0177] In some embodiments is a formulation described herein,
wherein the concentration of Poria cocos root extract in the
formulation is from about 0.2% to about 0.6% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of cinnamon extract in the formulation is from about
0.2% to about 0.6% by weight. In some embodiments is a formulation
described herein, wherein the concentration of Fenugreek in the
formulation is from about 0.2% to about 0.6% by weight. In some
embodiments is a formulation described herein, wherein the
concentration of Guggul in the formulation is from about 0.2% to
about 0.6% by weight.
[0178] In some embodiments is a formulation described herein,
optionally further comprising broad bean powder in a concentration
from about 0.2% to about 0.6% by weight. In some embodiments is a
formulation described herein, wherein the excipient comprises
gelatin, cellulose, medium-chain triglyceride (MCT) oil, silicon
dioxide, stearic acid, xanthan gum, potassium sorbate, turmeric
powder, primrose oil, lemon oil, or combinations thereof.
[0179] In some embodiments, formulations that comprise ingredients
at additional concentrations are also contemplated. In some
instances, the concentration of dandelion extract is from about 5%
to about 40%, about 6% to about 36%, about 8% to about 35%, about
9% to about 34%, or about 10% to about 30% by weight.
[0180] In some instances, the concentration of milk thistle extract
is from about 1% to about 20%, about 3% to about 15%, about 5% to
about 12%, or about 8% to about 10% by weight.
[0181] In some instances, the concentration of phospholipids is
from about 1% to about 15%, about 1% to about 12%, about 2% to
about 10%, or about 5% to about 8% by weight. In some cases, the
concentration of ginger is from about 0.5% to about 15%, about 1%
to about 10%, about 2% to about 8%, or about 3% to about 6% by
weight. In some instances, the concentration of taurine is from
about 0.5% to about 10%, about 1% to about 8%, about 2% to about
7%, or about 3% to about 6% by weight. In some instances, the
concentration of curcumin is from about 0.5% to about 10%, about 1%
to about 8%, about 2% to about 7%, or about 3% to about 6% by
weight.
[0182] In some embodiments, the concentration of turmeric extract
is from about 0.5% to about 10%, about 1% to about 8%, about 2% to
about 6%, or about 3% to about 5% by weight. In some instances, the
concentration of vitamin C about 1% to about 10%, about 1% to about
8%, about 2% to about 7%, or about 3% to about 6% by weight. In
some instances, the concentration of vitamin B is from about 0.5%
to about 10%, about 1% to about 10%, about 1% to about 8%, about 2%
to about 7%, or about 3% to about 6% by weight. In some
embodiments, the concentration of methionine is from about 0.5% to
about 15%, about 1% to about 11%, % to about 10%, about 1% to about
8%, about 2% to about 7%, or about 3% to about 6% by weight.
[0183] In some cases, the concentration of magnesium is from about
5% to about 60%, about 10% to about 55%, about 12% to about 50%, or
about 15% to about 40% by weight.
[0184] In some instances, the concentration of trimethylglycine is
from about 0.5% to about 50%, about 1% to about 40%, about 2% to
about 35%, about 3% to about 30%, or about 5% to about 20% by
weight.
[0185] In some instances, the concentration of glutathione is from
about 0.5% to about 40%, about 0.5% to about 35%, about 1% to about
30%, about 6% to about 25%, or about 8% to about 20% by weight.
[0186] In some embodiments, the concentration of N-acetyl-cysteine
is from about 0.5% to about 40%, about 0.5% to about 35%, about 1%
to about 30%, about 6% to about 25%, or about 8% to about 20% by
weight.
[0187] In some instances, the concentration of Cordyceps sinensis
extract is from about 0.5% to about 6%, about 0.8% to about 5%,
about 1% to about 4%, or about 1.2% to about 3% by weight.
[0188] In some cases, the concentration of glutamine is from about
0.5% to about 6%, about 0.8% to about 5%, about 1% to about 4%, or
about 1.2% to about 3% by weight.
[0189] In some instances, the concentration of alpha lipoic acid is
from about 0.5% to about 6%, about 0.8% to about 5%, about 1% to
about 4%, or about 1.2% to about 3% by weight.
[0190] In some instances, the concentration of glycine is from
about 0.5% to about 6%, about 0.8% to about 5%, about 1% to about
4%, or about 1.2% to about 3% by weight.
[0191] In some instances, the concentration of selenium is from
about 0.1% to about 5% by weight. In some instances, the
concentration of selenium is about 0.2%, 0.4%, 0.6%, 0.8%, 1%,
1.2%, 1.4%, 1.6%, 1.8%, 2%, 3%, 4%, or 5% by weight.
[0192] In some embodiments, the concentration of SAMe is from about
0.1% to about 5% by weight. In some instances, the concentration of
selenium is about 0.2%, 0.4%, 0.6%, 0.8%, 1%, 1.2%, 1.4%, 1.6%,
1.8%, 2%, 3%, 4%, or 5% by weight.
[0193] In some instances, the concentration of pea protein isolate
is from about 10% to about 60%, about 11% to about 57%, about 15%
to about 55%, or about 20% to about 40% by weight.
[0194] In some instances, the concentration of sacha inchi protein
is from about 0.5% to about 10%, about 1% to about 10%, about 1% to
about 8%, about 2% to about 7%, or about 3% to about 6% by
weight.
[0195] In some embodiments, the concentration of maca is from about
0.5% to about 3%. In some embodiments, the concentration of maca is
about 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.5%, 2%0, 2.5%/0, or 3% by
weight.
[0196] In some instances, the concentration of Cornus officinalis
is from about 0.5% to about 3%. In some embodiments, the
concentration of Cornus officinalis is about 0.6%, 0.7%, 0.8%,
0.9%, 1%, 1.5%, 2%, 2.5%, or 3% by weight.
[0197] In some cases, the concentration of berberine is from about
3% to about 40%, about 5% to about 30%, about 6% to about 28%,
about 6% to about 18% by weight.
[0198] In some instances, the concentration of bitter melon extract
is from about 0.1% to about 20%, about 0.2% to about 18%, about
0.5% to about 15%, about 1% to about 12%, or about 4% to about 8%
by weight.
[0199] In some instances, the concentration of Gymnema sylvestre
leaf extract is from about 3% to about 30%, about 5% to about 20%,
about 6% to about 18%, about 8% to about 18%, or about 10% to about
15% by weight.
[0200] In some instances, the concentration of banaba is from about
0.1% to about 20%, about 0.2% to about 18%, about 0.5% to about
15%, about 1% to about 12%, or about 4% to about 8% by weight.
[0201] In some cases, the concentration of carnitine is from about
1% to about 5% or about 2% to about 5% by weight. In some
instances, the concentration of carnitine is about 2%, 3%, or
4%.
[0202] In some instances, the concentration of Panax ginseng root
extract is from about 3% to about 30%, about 5% to about 21%, about
6% to about 18%, or about 8% to about 15% by weight.
[0203] In some instances, the concentration of Aswagandha root
extract is from about 1% to about 30%, about 2% to about 20%, about
4% to about 16%, or about 6% to about 12% by weight.
[0204] In some instances, the concentration of holy basil leaf
extract is from about 1% to about 15%, about 3% to about 13%, or
about 4% to about 10% by weight.
[0205] In some instances, the concentration of Rhodiola rosea
extract is from about 1% to about 15%, about 2% to about 10%, or
about 3% to about 8% by weight.
[0206] In some cases, the concentration of Eleutherococcus
senticosus extract is from about 1% to about 10%, or about 1% to
about 7% by weight.
[0207] In some instances, the concentration of cactus stem extract
is from about 1% to about 15%, or about 1% to about 8% by
weight.
[0208] In some embodiments, the concentration of phosphatidylserine
is from about 20% to about 90%, about 30% to about 80%, or about
40% to about 60% by weight.
[0209] In some instances, the concentration of broad bean is from
about 0.05% to about 0.3% or from about 0.1% to about 0.2% by
weight.
[0210] In some embodiments, the concentration of Garcinia cambogia
extract is from about 0.1% to about 1%, about 0.1% to about 0.7%,
about 0.2% to about 0.6%, or about 0.4% to about 0.6% by
weight.
[0211] In some instances, the concentration of Rehmania glutinosa
extract is from about 0.1% to about 1%, about 0.1% to about 0.7%,
about 0.2% to about 0.6%, or about 0.4% to about 0.6% by
weight.
[0212] In some embodiments, the concentration of Poria cocos root
extract is from about 0.1% to about 1%, about 0.1% to about 0.7%,
about 0.2% to about 0.6%, or about 0.4% to about 0.6% by
weight.
[0213] In some instances, the concentration of cinnamon extract is
from about 0.1% to about 1%, about 0.1% to about 0.7%, about 0.2%
to about 0.6%, or about 0.4% to about 0.6% by weight.
[0214] In some cases, the concentration of Fenugreek is from about
0.1% to about 1%, about 0.1% to about 0.7%, about 0.2% to about
0.6%, or about 0.4% to about 0.6% by weight.
[0215] In some embodiments, the concentration of Guggul is from
about 0.1% to about 1%, about 0.1% to about 0.7%, about 0.2% to
about 0.6%, or about 0.4% to about 0.6% by weight.
[0216] In some embodiments, the concentration of omega-3 is from
about 15% to about 100%, about 20% to about 90%, or about 25% to
about 80%. In some instances, the concentration of omega-3 is about
30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, or 75%. In some cases,
the omega-3 concentration is calculated based on the concentration
of eicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA).
In some instances, the concentration of EPA is from about 15% to
about 100%, about 2% to about 90%, or about 25% to about 80%. In
some instances, the concentration of EPA is about 30%, 35%, 40%,
45%, 50, 55%, 60%, 65%, 70%, or 75%. In some embodiments, the
concentration of DHA is from about 15% to about 100%, about 20% to
about 90%, or about 25% to about 80%. In some embodiments, the
concentration of DHA is about 30%, 35%, 40%, 45%, 50%, 55%, 60%,
65%, 70%, or 75%.
[0217] In some embodiments, at least one formulation disclosed
herein is suitable for reducing the need for insulin
administration. In some embodiments, at least one formulation
disclosed herein is used for hippocampus rehabilitation. In some
embodiments, at least one formulation disclosed herein is suitable
for supporting, controlling, restoring, maintaining or enhancing
blood sugar metabolism. In some embodiments, at least one
formulation disclosed herein is suitable for stabilizing or
reducing hemoglobin A1C levels. In some embodiments, at least one
formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing liver function in
a subject. In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining enhancing normal liver function in a subject. In some
embodiments, at least one formulation disclosed herein is suitable
for supporting, controlling, restoring, maintaining or enhancing
gall bladder function in a subject. In some embodiments, at least
one formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing liver
detoxification in a subject. In some embodiments, at least one
formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing the immune system
in a subject. In some embodiments, at least one formulation
disclosed herein is suitable for supporting, controlling,
restoring, maintaining or enhancing healthy brain function in a
subject. In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing digestion in a subject. In some
embodiments, at least one formulation disclosed herein is suitable
for supporting, controlling, restoring, maintaining or enhancing
platelet activity in a subject.
[0218] In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing blood sugar metabolism. In some
embodiments, at least one formulation disclosed herein is suitable
for supporting, controlling, restoring, maintaining or enhancing
blood sugar in a subject with insufficient insulin. In some
embodiments, at least one formulation disclosed herein is suitable
for supporting, controlling, restoring, maintaining or enhancing
liver function. In some embodiments, at least one formulation
disclosed herein is suitable for supporting, controlling,
restoring, maintaining or enhancing normal cholesterol level. In
some embodiments, at least one formulation disclosed herein is
suitable for supporting, controlling, restoring, maintaining or
enhancing red blood cell formation. In some embodiments, at least
one formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing a healthy salt
balance within the body fluid. In some embodiments, at least one
formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing gastrointestinal
health. In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing gall bladder function. In some
embodiments, at least one formulation disclosed herein is suitable
for supporting, controlling, restoring, maintaining or enhancing
liver detoxification. In some embodiments, at least one formulation
disclosed herein is suitable for supporting, controlling,
restoring, maintaining or enhancing the immune system. In some
embodiments, at least one formulation disclosed herein is suitable
for supporting, controlling, restoring, maintaining or enhancing a
healthy brain function. In some embodiments, at least one
formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing digestion. In some
embodiments, at least one formulation disclosed herein is suitable
for supporting, controlling, restoring, maintaining or enhancing
platelet activity. In some embodiments, at least one formulation
disclosed herein is suitable for supporting, controlling,
restoring, maintaining or enhancing healthy adrenal feedback loop
function. In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing a normal sleep pattern. In some
embodiments, at least one formulation disclosed herein formulation
is suitable for supporting, controlling, restoring, maintaining or
enhancing mental alertness or wakefulness. In some embodiments, at
least one formulation disclosed herein formulation is suitable for
supporting, controlling, restoring, maintaining or enhancing normal
bone density. In some embodiments, at least one formulation
disclosed herein formulation is suitable for supporting,
controlling, restoring, maintaining or enhancing hormonal balance.
In some embodiments, at least one formulation is suitable for
supporting, controlling, restoring, maintaining or enhancing
cognitive function. In some embodiments, at least one formulation
is suitable for supporting, controlling, restoring, maintaining or
enhancing thyroid function. In some embodiments, at least one
formulation is suitable for supporting, controlling, restoring,
maintaining or enhancing normal menstruation. In some embodiments,
at least one formulation is suitable for supporting, controlling,
restoring, maintaining or enhancing joint health. In some
embodiments, at least one formulation is suitable for supporting,
controlling, restoring, maintaining or enhancing insulin receptor
function. In some embodiments, at least one formulation is suitable
for supporting, controlling, restoring, maintaining or enhancing
healthy arterial wall. In some embodiments, at least one
formulation is suitable for supporting, controlling, restoring,
maintaining or enhancing a healthy heart function. In some
embodiments, at least one formulation is suitable for supporting,
controlling, restoring, maintaining or enhancing DNA repair
function. In some embodiments, at least one formulation is suitable
for supporting, controlling, restoring, maintaining or enhancing
dopamine production and function.
[0219] In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing the health of those suffering from
diabetes (or complication from diabetes) or those who are
predisposed to pre-diabetes. In some embodiments, at least one
formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing the health of
those concerned with maintaining proper blood sugar control or
those who currently have normal blood sugar but who have a history
of blood sugar control problem.
[0220] In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing natural liver function, natural blood
sugar metabolism, natural blood sugar levels, glycemic control,
natural insulin response to glucose load, insulin health, natural
iron and sugar utilization, peripheral glucose utilization, natural
cellular uptake of glucose, secretions of insulin and glucagon,
natural glucose tolerance, natural insulin receptor site
sensitivity, or the activity of glucokinase.
[0221] In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing organ health. In some embodiments, at
least one formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing the health of the
circulatory system, eyes, ears, skin, mouth (oral), soft tissue,
scalp, skeletal tissue, cartilage, connective tissue, liver,
kidney, gall bladder, muscle, bone, joint, hair, nails,
musculoskeletal, or mucous membranes.
[0222] In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing natural bone growth, natural growth and
repair of tissues, gene expression, cellular repair, or health and
integrity of cellular tissue.
[0223] In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing reproductive health. In some embodiments,
at least one formulation disclosed herein is suitable for
supporting, controlling, restoring, maintaining or enhancing female
reproductive health, male reproductive health, menstruation health,
or male sexual function health.
[0224] In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing hormone health. In some embodiments, at
least one formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing hormone health in
a subject suffering from Polycystic Ovarian Syndrome (PCOS). In
some embodiments, at least one formulation disclosed herein is
suitable for supporting, controlling, restoring, maintaining or
enhancing adrenal function or adrenal hormones.
[0225] In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing heart and cardiovascular health. In some
embodiments, at least one formulation disclosed herein is suitable
for supporting, controlling, restoring, maintaining or enhancing
healthy red blood cells, natural white blood cell levels, natural
heme production, small blood vessel health, healthy blood pressure
levels, or platelet function.
[0226] In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing healthy cholesterol levels. In some
embodiments, at least one formulation disclosed herein is suitable
for supporting, controlling, restoring, maintaining or enhancing
triglyceride levels, natural breakdown of fats, or natural biliary
levels. In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing digestive health. In some embodiments, at
least one formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing colon health,
nutrient transportation, intestinal health, natural absorption of
minerals, or natural nutrient utilization.
[0227] In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing a healthy nervous system. In some
embodiments, at least one formulation disclosed herein is suitable
for supporting, controlling, restoring, maintaining or enhancing
neuro-protection, brain function and memory, natural nerve
transmission, or GABA. In some embodiments, at least one
formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing healthy stress
responses, natural stress responses, or physical and mental
well-being health. In some embodiments, at least one formulation
disclosed herein is suitable for supporting, controlling,
restoring, maintaining or enhancing respiratory health. In some
embodiments, at least one formulation disclosed herein is suitable
for supporting, controlling, restoring, maintaining or enhancing
appetite control or weight control. In some embodiments, at least
one formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing, homocysteine
levels, natural production of nucleic acids and creatine phosphate,
the manufacture and carbohydrate utilization, fats, and amino
acids, natural protein synthesis, natural enzymatic reactions, or
chemical reactions. In some embodiments, at least one formulation
disclosed herein is suitable for supporting, controlling,
restoring, maintaining or enhancing detoxification or
neutralization of toxin. In some embodiments, at least one
formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing antioxidant health
or natural glutathione levels. In some embodiments, at least one
formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing energy levels
(stamina). In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing natural pH levels. In some embodiments, at
least one formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing natural recovery
time. In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing metabolism health. In some embodiments, at
least one formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing natural tryptophan
metabolism, natural blood sugar metabolism, or methionine
metabolism. In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing natural thermogenesis. In some
embodiments, at least one formulation disclosed herein is suitable
for supporting, controlling, restoring, maintaining or enhancing
natural cell division. In some embodiments, at least one
formulation disclosed herein is suitable for supporting,
controlling, restoring, maintaining or enhancing the immune system
health. In some embodiments, at least one formulation disclosed
herein is suitable for supporting, controlling, restoring,
maintaining or enhancing healthy uric acid levels. In some
embodiments, at least one formulation is suitable for controlling
stress. In some embodiments, at least one formulation is suitable
for relieving stress.
[0228] In some embodiments, one or more formulations described
herein may be used as a dietary supplement and/or anticancer agent.
The formulations may comprise either the above listed ingredients,
its active compounds, or said ingredients and active compounds plus
one or more pharmaceutically acceptable carriers. In addition to
the ingredients discussed above, methods of determining active
ingredients and screening for activity in the formulations
described herein can be carried out according to methods known to
those of skill in the art, and according to methods described in
the examples herein. Formulations described herein may be mixed
with pharmaceutically acceptable carriers or excipients known to
those of skill in the art, and administered according to methods
known to those of skill in the art including:
[0229] i.) Oral Administration in the form of juice, powders,
tablets, suspension, emulsifiers, capsules, granules, troches,
pills, suspensions, spirits, syrups, and limonades;
[0230] ii.) Injectable Administration intravenously or
otherwise;
[0231] iii) Topical Administration in the form of ointments,
solids, suspensions, powders, paps, suppositories, aerosols,
cataplasms, liniments, lotions, enemas, and emulsifiers.
[0232] In addition, well-known excipients in the form of solid or
liquid maybe used. The several examples of excipients used to
administer the dosage forms are as follows:
[0233] Excipients in powders and other oral powders: lactose,
crystalline cellulose, starch, dextrin, calcium phosphate, calcium
carbonate, synthetic and natural aluminum dioxide, magnesium oxide,
dried aluminum hydroxide, magnesium stearate, and sodium
bicarbonate;
[0234] Excipients in topical powders: zinc oxide, talc, starch,
kaolin, borate powder, zinc stearate, magnesium stearate, magnesium
carbonate, precipitated calcium carbonate, bismuth subgallate, and
potassium aluminum sulfate powder;
[0235] Excipients in liquids: water, glycerin, propylene glycol,
sweet-taste syrup, ethanol, fatty oil, ethylene glycol,
polyethylene glycol, and sorbitol;
[0236] Excipients in ointments: hydrophobic or hydrophilic base
(including oil soluble base, water-soluble base and suspended base)
prepared by mixing fat, fatty oil, lanoline, Vaseline, glycerin
wax, Japan wax, paraffin, paraffin sulphate, resins, higher
alcohols, plastics, glycols, water, or surfactant.
[0237] Formulations discussed herein can be administered in any of
the forms considered herein, or otherwise known to those of skill
in the art. In some embodiments, the formulation is administered
orally in a liquid form, either as an extract, concentrated extract
or other liquid form. In some embodiments, the formulation is
administered orally twice a day, three times a day, or four times a
day, with each dosing varying between 5 oz-20 oz. depending on the
person's state of health, weight, severity of disease, response of
disease or conditions.
[0238] A formulation described herein may be administered as a
dietary supplement to facilitate normal physiological function and
growth.
[0239] In certain instance, it is appropriate to administer the
formulation disclosed herein in combination with an additional
therapeutic agent. In some embodiments, the additional therapeutic
agent comprises insulin, metformin, sulfonylureas, meglitinides,
thiazolidinediones, DPP-4 inhibitors, GLP-1 receptor agonists,
SGLT2 inhibitors, diuretics, beta-blockers, ACE inhibitors,
angiotensin II receptor blockers, calcium channel blockers, alpha
blockers, alpha-2 receptor agonist, central agonists, peripheral
adrenergic inhibitors, vasodilators or a combination thereof. In
some embodiments, the additional therapeutic agent comprises CETP
inhibitors, FXR agonist, LXR agonist, HMG-CoA reductase inhibitors,
bile acid sequestrants, niacin and related compounds, PPARalpha
agonists, cholesterol absorption inhibitors, ACAT inhibitors,
phenolic anti-oxidant, LDL receptor inducers, platelet aggregation
inhibitors, ileal bile acid transporter or a combination
thereof.
TABLE-US-00001 TABLE A Representative ingredients and nutritional
details of one serving of an exemplary formulation described
herein. The formulation may also contain one or more additional
ingredients not listed in Table A. Supplemental Facts.dagger.
Serving size: 1 Pouch (14.5 g) Amount Per Serving % Daily Value
Calories 40 1%* Total fat 0.5 1%* Total carbohydrate 4 g 7%*
Dietary fiber 2 g Sugars 0 g Protein 6 g Vitamin A 850 IU 17%
Vitamin C 250 mg 416% Vitamin D 50 IU 12% Vitamin E 17 IU 56%
Thiamine 57.5 mg 3833% Riboflavin 12 mg 705% Niacin 25 mg 125%
Vitamin B6 14 mg 700% Folate 1250 mcg 312% Vitamin B12 700 mcg
11667% Biotin 2000 mcg 667% Pantothenic acid 22 mg 220% Calcium 150
mg 15% Phosphorus 10 mg 1% Magnesium 190 mg 48% Zinc 12.5 mg 84%
Selenium 10 mcg 15% Copper 210 mcg 11% Manganese 4 mg 200% Chromium
40 mcg 33% Molybdenum 200 mcg 266% Trimethylglycine 550 mg *
Evening Primrose oil powder 450 mg * Inulin 460 mg * Medium Chain
Triglycerides 260 mg * Oil powder Quercetin Dihydrate 88 mg * Rutin
88 mg * Hesperidin complex 70 mg * Milk Thistle extract 230 mg
L-Taurine 98 mg * Choline bitartrate 100 mg * Betaine Hydrochloride
110 mg * Marshmallow 30 mg * Curcumin 140 mg * L-Glutamine 250 mg *
N-Acetyl L-Cysteine 100 mg * Ginger root 40 Bromelain Concentrate
0.5 1%* Methylsulfonymethane 4 g 1%* S-Anenosylmethionine 2 g 7%*
Dandelion Root Powder 0 g Lecithin Powder 6 g Beet Root Powder 850
IU 17% Protease 250 mg 416% Superoxide Dismutase 50 IU 12% Catalase
17 IU 56% Sarsaparilla Root 57.5 mg 3833% DI-Methionine 12 mg 705%
L-Glutathione 25 mg 125% Ginseng Root Powder 14 mg 700% L-Glycine
1250 mcg 312% Alpha R-Lipoic Acid 700 mcg 11667% Watercress Leaf
Powder 2000 mcg 667% Cellulase 22 mg 220% Lactase 150 mg 15% Lipase
10 mg 1% Jerusalem Artichoke 190 mg 48% .dagger.Daily Values are
based on a 2,000 calorie diet *Daily Value (DV) not established
TABLE-US-00002 TABLE B Representative ingredients and nutritional
details of one serving of an exemplary formulation described
herein. The formulation may also contain one or more additional
ingredients not listed in Table B. Supplemental Facts.dagger.
Serving size: 1 Pouch (15.4 g) Amount Per Serving % Daily Value
Calories 35 Calories from Fat 5 Total fat 0.5 1%* Total
carbohydrate 3 g 1% Dietary fiber 2 g 8% Sugars 0 g Protein 6 g
Vitamin C 150 mg 250% Vitamin E 1400 IU 350% Thiamine 90 IU 300%
Riboflavin 35 mg 2333% Niacin 10 mg 588% Vitamin B6 45 mg 225%
Folate 3.8 190% Vitamin B12 160 mcg 40% Biotin 14 mcg 234%
Magnesium 650 mg 217% Zinc 50 mg 13% Selenium 10 mg 67% Manganese
40 mcg 84% Chromium 280 mcg 15% Vanadium 20 mcg 11% R-Alpha-Lipoic
Acid 84 mg 200% Banaba 300 mg 33% Berberine Hydrochloride 500 mg
266% Bitter Melon 301 mg * Cactus Stem Extract 125 mg * Choline
Bitartrate 85 mg * Cinnamon Extract 7 mg * Citrimax Extract 7 mg *
Fenugreek 7 mg * Guggul 7 mg * Poria Cocos Root Extract 7 mg *
Rehmannia Glutinosa 40 mg * Rhizome Gymnema Sylvestre Leaf 450 mcg
* Extract Inositol 11 mg * L-Carnitine L-Tartrate 96 mg * PABA 10
mg * Asiatic Dogwood Fruit 33 mg * Extract Cordyceps Sinensis 33 mg
* Gingko Biloba leaf extract 33 mg * Maca 33 mg * Suma Root 33 mg *
Aswagandha Root 200 mg * Holy Basil Leaf Extract 200 mg * Rhodiola
Rosea Extract 200 mg * Eleutherococcus 100 mg * Pantethine 180 mg *
Superoxide Dismutase 165 mg * Milk Thistle 80% Silymarin 70 mg *
Ginseng Root Extract 350 mg * Salacia Oblonga Extract 250 mg *
Phospholipid Complex 330 mg * Phosphotidyl Serine 165 mg * S-Acetyl
L-Glutathione 240 mg * N-Acetyl L-Cysteine 305 mg * L-Glutamine 195
mg * .dagger.Daily Values are based on a 2,000 calorie diet *Daily
Value (DV) not established
TABLE-US-00003 Representative ingredients and nutritional details
of one serving of an exemplary formulation described herein. The
formulation may also contain one or more additional ingredients not
listed in Table C. Supplemental Facts.dagger. Serving size: 1 Pouch
(12.5 g) Amount Per Serving % Daily Value Calories 35 Calories from
Fat 5 Total fat 0.5 1%* Total carbohydrate 3 g 1%* Dietary fiber 2
g 7%* Sugars 0 g Protein 6 g Vitamin C 360 mg 600% Vitamin D 1000
IU 250% Vitamin E 90 IU 300% Vitamin K2 40 mcg 50% Thiamine 29 mg
1933% Riboflavin 10 mg 588% Niacin 25 mg 125% Vitamin B6 10 mg 500%
Folate 1600 mcg 40% Vitamin B12 12 mcg 200% Biotin 650 mcg 200%
Calcium 50 mg 5% Magnesium 25 mg 6% Zinc 6 mg 40% Selenium 40 mcg
60% Manganese 5 mg 250% Chromium 280 mcg 235% Molybdenum 70 mcg 93%
Vanadium 20 mcg * R-Alpha-Lipoic Acid 85 mg * Banaba 160 mg *
Berberine Hydrochloride 340 mg * Bitter Melon Extract 160 mg *
Cactus Stem Extract 60 mg * Choline Bitartrate 85 mg * Cinnamon
Extract 9 mg * Citrimax Extract 12 mg * Fenugreek 12 mg * Guggul 9
mg * Pantethine 75 mg * Poria Cocos Root Extract 9 mg * Rehmannia
Glutinosa 9 mg * Rhizome Gymnema Sylvestre Leaf 300 mg * Extract
Inositol 12 mg * L-Carnitine L-Tartrate 60 mg * PABA 10 mg *
N-Acetyl L-Cysteine 310 mg * CoQ-10 10 mg * Taurine 90 mg
.dagger.Daily Values are based on a 2,000 calorie diet *Daily Value
(DV) not established
[0240] Exemplary Methods
[0241] Provided herein are methods comprising administration of at
least one formulation described herein, for the treatment of
diabetes in in subject. In some embodiments, are methods for the
treatment of pre-diabetic symptoms in a subject. In certain
embodiments are methods for the regulation of blood sugar in a
subject. Certain methods described herein may comprise
administration of a formulation described herein for the regulation
of insulin levels in a subject.
[0242] Provided are methods for the treatment of type II diabetes
in a subject comprising: administering to the subject a first
formulation described herein for at least about 10 days;
administering to the subject a second formulation described herein
for at least about 30 days; and optionally administering to the
subject a third formulation described herein. In some embodiments,
a formulation described herein is administered with an additional
agent. The additional agent may comprise insulin, metformin,
sulfonylureas, meglitinides, thiazolidinediones, DPP-4 inhibitors,
GLP-1 receptor agonists, SGLT2 inhibitors, or a combination
thereof.
[0243] In some embodiments is a method of supporting glucose level
in a subject's blood comprising administering to the subject one or
more formulations described herein. In some embodiments is a method
of supporting glucose level in a subject's blood comprising
administering to the subject a formulation described herein, and
optionally administering to the subject a second formulation
described herein.
[0244] Provided are methods comprising administration of at least
one formulation described herein, wherein at least one formulation
is administered orally, intravenously, intraperitoneal,
subcutaneous, topically, or a combination thereof. Optionally, at
least one formulation is administered as a pill, or as two or more
pills. In some embodiments, the two or more pills are administered
simultaneously, sequentially, or intermittently. In some
embodiments, at least one formulation is administered as a powder
formulation. In some embodiments, at least one formulation is
administered as a combination of one or more pills and a powder
formulation. The combination maybe administered simultaneously,
sequentially, or intermittently.
[0245] In some methods provided herein, at least one formulation is
administered as a liquid formulation. In some cases, the liquid
formulation may be obtained by reconstituting a powder formulation
in a liquid. In some cases, at least one formulation is
administered as a combination of one or more pills and a liquid
formulation. In certain embodiments, the combination is
administered simultaneously, sequentially, or intermittently.
[0246] In some methods provided herein, at least one formulation is
administered as an emulsion formulation. In certain embodiments, at
least one formulation is administered as a combination of one or
more pills and an emulsion formulation. The combination maybe
administered simultaneously, sequentially, or intermittently.
[0247] In some methods provided herein, at least one formulation is
mixed in food. In some cases, the food is a beverage, a shake, or a
snack. In some instances, the beverage is tea, coffee, or energy
drink. In an embodiment, the food is consumed by the subject as
part of a meal or diet plan.
[0248] Provided herein are methods of controlling blood sugar in a
subject with insufficient insulin comprising administering to the
subject a formulation described herein. In some embodiments, is a
method of controlling blood sugar in a subject with insufficient
insulin comprising administering to the subject a formulation
described herein, and optionally administering to the subject at
least one second formulation described herein.
[0249] Provided is a method of supporting liver function comprising
administering to a subject in need thereof a formulation described
herein. In some embodiments is a method of supporting liver
function comprising administering to the subject a formulation
described herein, and optionally administering to the subject at
least one second formulation described herein.
[0250] Provided is a method of maintaining normal cholesterol level
comprising administering to a subject in need thereof a formulation
described herein. In certain embodiments, is a method of
maintaining normal cholesterol level comprising administering to
the subject a formulation described herein, and optionally
administering to the subject at least one second formulation
described herein. In some embodiments are methods of supporting
normal cholesterol level comprising administering to a subject in
need thereof a formulation described herein. In some embodiments
are methods of maintaining healthy arterial wall comprising
administering to a subject in need thereof a formulation described
herein.
[0251] Provided is a method of supporting red blood cell formation
comprising administering to a subject in need thereof a formulation
described herein.
[0252] In some embodiments is a method of for supporting,
controlling, restoring, or maintaining blood sugar levels in an
individual comprising administering to the individual an amount of
at least one formulation comprising: group A components consisting
essentially of at least one protein optionally selected from a list
comprising pea protein isolate and sacha inchi protein; at least
one group B component that comprises dandelion extract, milk
thistle extract, phospholipids, ginger, taurine, turmeric extract,
vitamin C, or methionine; at least one group C component that
comprises magnesium, trimethylglycine, glutathione,
N-acetyl-cysteine, Cordyceps sinensis extract, glutamine, alpha
lipoic acid, or glycine; and an excipient.
[0253] Provided is a method of for supporting, controlling,
restoring, or maintaining blood sugar metabolism in an individual
comprising administering to the individual an amount of at least
one formulation comprising: group A components consisting
essentially of maca, Cornus officinalis fruit extract, and
optionally broad bean; at least one group B component that
comprises berberine, bitter melon extract, Gymnema sylvestre leaf
extract, banaba, or carnitine; at least one group C component that
comprises vitamin C, Panax ginseng root extract, Aswagandha root
extract, holy basil leaf extract, Rhodiola rosea extract,
Eleutherococcus senticosus extract, vitamin B5, cactus stem
extract, phosphatidylserine, or vitamin D; and an excipient.
[0254] Provided is a method of for supporting, controlling,
restoring, or maintaining blood sugar metabolism in an individual
comprising administering to the individual an amount of at least
one formulation comprising: group A components consisting
essentially of cactus stem extract and optionally broad bean; at
least one group B component that comprises berberine, bitter melon
extract, Gymnema sylvestre leaf extract, banaba, or carnitine; at
least one group C component that comprises Garcinia cambogia
extract, Rehmannia glutinosa extract, Poria cocos root extract,
cinnamon extract, Fenugreek, Guggul, or Vitamin D; and an
excipient.
[0255] In some embodiments, is a method described herein, wherein
the individual suffers from insulin insufficiency. In certain
embodiments, the individual is diabetic. In some embodiments, the
individual is pre-diabetic. In certain embodiments, a formulation
described herein is administered to the individual for a period of
about 10, 15, 20, 30, 40, 45, 50, or 60 days. In some embodiments,
a formulation described herein may be administered to the
individual said formulation for a period of about one month to
about sixty months.
[0256] In some embodiments, a method described herein further
comprises use of a diet plan. In certain embodiments, the diet plan
further comprises recipes. In some embodiments, the diet plan
further comprises recipes for at least one of breakfast, lunch,
snacks, and dinner.
[0257] Exemplary Kits
[0258] Provided are kits for use in the methods described herein.
In some embodiments are provided kits comprising at least one
formulation described herein; and instructions for use thereof. In
certain embodiments is a kit described herein, further comprising
at least one diet plan or meal plan. In some embodiments, the kit
further comprises at least one recipe.
[0259] In some embodiments is a kit useful for supporting,
controlling, restoring, or maintaining blood sugar levels in an
individual comprising: at least one formulation described herein;
instructions for use of the at least one formulation; and
optionally at least one diet plan.
[0260] A diet plan described herein may further comprise recipes.
In some embodiments, the diet plan further comprises recipes for at
least one of breakfast, lunch, snacks, and dinner.
[0261] In some embodiments, at least one diet plan is tailored to
complement said at least one formulation. In some embodiments, the
diet plan is tailored based on the level of at least one indicator
in the individual. In certain cases, the at least one indicator is
body mass index (BMI), liver fat level or hemoglobin A1C count.
[0262] In some embodiments, a kit described herein is useful for
the treatment of diabetes. In some cases, the kit is useful for the
management of blood sugar. In certain cases, the kit further
comprises at least one additional therapeutic agent. In a few
cases, the additional agent comprises insulin, metformin,
sulfonylureas, meglitinides, thiazolidinediones, DPP-4 inhibitors,
GLP-1 receptor agonists, SGLT2 inhibitors, or a combination
thereof.
[0263] Exemplary Diet Plans
[0264] In some embodiments provided herein are diet plans (also
referred to as diet regimen or simply regimen) for implementation
in conjugation with the methods and formulations described herein.
A diet plan described herein maybe included in a method and/or kit
described herein. In certain embodiments, a diet plan described
herein is tailored for the individual based on an understanding of
the symptoms exhibited by the individual. In some embodiments, a
diet plan described herein works in synergy with a method and/or
formulation described herein to achieve a desired result. In some
embodiments, the desired result in a reduction or stabilization of
blood glucose levels. In certain embodiments, the desired result is
a reduction or elimination of insulin administration. In certain
embodiments, the desired result is a reduction in BMI. In certain
embodiments, the desired result is a reduction or elimination of
one or more symptoms of type II diabetes or an associated condition
described herein.
[0265] In some embodiments, the diet plans described herein, are
designed to support some of the integral systems of human
physiology, which include, but are not limited to, blood sugar
metabolism, insulin receptor site sensitivity, anti-inflammatory
support, liver function, gastro-intestinal system, immune system,
brain function, adrenal gland functions, anti-oxidant support. In
some embodiments, the plans and regimens described herein, are
designed to ameliorate diabetes directly. In some embodiments, the
regimens described herein, are designed to ameliorate the most
common underlying issues associated with your diabetes.
[0266] In some embodiments, the diet plans described herein
comprises administration of the compositions and formulations
described herein to an individual. In some embodiments, the
compositions and formulations described herein are administered in
the form of pills, tablets, liquid formulations, shakes etc. In
some embodiments, the shakes are flavored. In some embodiments, the
compositions described herein are in the form of powders and
packaged in packets or pouches. In some embodiments, the
formulation in the regimen is a powder that can be mixed with cold
water or unsweetened almond milk. In some embodiments the contents
of the packets or pouches are mixed with a potable liquid, until
the powder is completely in solution, to prepare a shake. In some
embodiments the formulation in the regimen is stirred.
[0267] In some embodiments, each packet represents one dose. In
some embodiments the formulation is placed in a container with a
lid that can be shaken. In some embodiments the contents of the
packets or pouches are mixed with up-to 8 ounces of water, to
prepare a shake. In some embodiments the contents of the packets or
pouches are mixed with less than 8 ounces of water, to prepare a
shake. In some embodiments the contents of the packets or pouches
are mixed with up-to 8 ounces of unsweetened almond milk, to
prepare a shake. In some embodiments the contents of the packets or
pouches are mixed with less than 8 ounces of unsweetened almond
milk, to prepare a shake. In some embodiments, the amount of water
or milk may be adjusted according to desired consistency of the
prepared shake. In some embodiments, the contents of the packets or
pouches are not mixed with almond milk, for administration to
individuals who are allergic to nuts.
[0268] In some embodiments, the compositions or formulations
described herein are administered, to individuals, as shakes three
times a day. In some embodiments, the formulation in the regimen is
taken for 30 days. In some embodiments, the diet regimen is
followed until desired quality of life outcomes are achieved.
Exemplary desired quality of life outcomes can include, but are not
limited to, weight loss, improved sleep patterns, reduced limb
pains, reduced joint pains, normalized blood pressure etc. In some
embodiments, the diet regimen is followed until normalized blood
sugar levels are achieved.
[0269] In some embodiments, the compositions described herein are
taken with breakfast. In some embodiments, the compositions
described herein are taken with lunch. In some embodiments, the
compositions described herein are taken with dinner. In some
embodiments, the compositions described herein are taken with
breakfast and dinner. In some embodiments, the compositions
described herein are taken with breakfast, lunch and dinner.
[0270] In some embodiments, the regimen is accompanied by plenty of
water. In some embodiments, the regimen is accompanied by herbal
teas. In some embodiments, the regimen is accompanied by decaf
green tea. In some embodiments, the regimen is accompanied by fresh
fruits (including blueberries, strawberries, blackberries, lemon,
banana, apple). In some embodiments, the regimen is accompanied by
vegetables (including celery, carrots, zucchini, cucumbers,
avocado, beets, eggplant, asparagus, onion, garlic, spinach,
lettuce, butternut squash, cauliflower, broccoli, peppers, yams and
sweet potatoes), beans (pinto, black, navy, white, red kidney), and
peas (including fresh, split, snap). In some embodiments, the
regimen is accompanied by fish. In some embodiments, the regimen is
accompanied by moderate amounts of chicken. In some embodiments,
the regimen is accompanied by moderate amounts of turkey. In some
embodiments, the regimen is accompanied by moderate amounts of
lamb. In some embodiments, the regimen is accompanied by olive oil.
In some embodiments, the regimen is accompanied by coconut oil. In
some embodiments, the regimen is accompanied by flaxseed oil (in
moderation). In some embodiments, the regimen is accompanied by
seeds and nuts. In some embodiments, peanuts are excluded. In some
embodiments, the regimen is accompanied by almond butter. In some
embodiments, the regimen is accompanied by cashew butter. In some
embodiments, the regimen is accompanied by unsweetened almond or
coconut milk. In some embodiments, the regimen is accompanied by
turkey bacon (nitrate/nitrite and gluten free). In some
embodiments, the regimen is accompanied by turkey sausage patties
(nitrate/nitrite and gluten free). In some embodiments, the regimen
is accompanied by skinny crisps--Plain Jane or Onion. In some
embodiments, the regimen is accompanied by Stevia, xylitol, Grade B
Maple Syrup, or coconut sugar. In some embodiments, the formulation
in the regimen is accompanied by a snack. In some embodiments the
snack comprises fresh berries, fruits, nuts, almond, cashew butter
on apples, celery, jicama, bananas, avocado, skinny crisps-plain
Jane or onion, or a combination thereof.
[0271] In some embodiments, dairy (milk, cheeses, yogurt, butter)
should be avoided. In some embodiments, eggs, margarine and
shortening should be avoided, while being on the regimen. In some
embodiments, foods prepared with gluten should be avoided, while
being on the regimen. In some embodiments, all grains (including
corn, rice, quinoa) should be avoided, while being on the regimen.
In some embodiments, tomatoes, tomato sauces, corn, and white
potatoes should be avoided. In some embodiments, peanuts or peanut
butter should be avoided, while being on the regimen. In some
embodiments, soy or products made from soy (including soymilk, meat
substitutes and tofu) should be avoided, while being on the
regimen. In some embodiments, beef should be avoided. In some
embodiments, pork should be avoided, while being on the regimen. In
some embodiments, cold cuts should be avoided, while being on the
regimen. In some embodiments, bacon should be avoided, while being
on the regimen. In some embodiments, hotdogs should be avoided. In
some embodiments, canned meat should be avoided, while being on the
regimen. In some embodiments, sausage should be avoided, while
being on the regimen. In some embodiments, shellfish should be
avoided, while being on the regimen. In some embodiments, honey,
sugar or artificial sweeteners should be avoided, while being on
the regimen. In some embodiments, alcohol should be avoided, while
being on the regimen. In some embodiments, caffeine (including
coffee, decaf coffee, black tea, soda/diet soda) should be avoided,
while being on the regimen. In some embodiments, fruit juices
should be avoided, while being on the regimen.
[0272] In some embodiments, junk foods (e.g.--soda pops, cookies,
cakes, candies, ice creams etc.) should be avoided, while being on
the regimen. In some embodiments, refined foods should be avoided,
while being on the regimen. In some embodiments, foods that contain
dairy, corn, wheat, gluten, soy should be avoided, while being on
the regimen. In some embodiments, consumption of alcohol should be
significantly reduced, while being on the regimen. In some
embodiments, consumption of caffeine should be significantly
reduced, while being on the regimen. In some embodiments, damaged
and harmful fats (e.g.--hydrogenated oils, trans fats etc.) should
be avoided, while being on the regimen. In some embodiments,
artificial sweeteners should be avoided, while being on the
regimen.
[0273] In certain embodiments, the introduction of additional food
items are allowed, while an individual is administered compositions
described herein. Additional food items can include, but are not
limited to, grains (including corn, rice), quinoa, tomatoes, tomato
sauces, corn, white potatoes, peanut butter, soy products, pork,
cold cuts, bacon, hot dog, canned meat, sausage, honey, sugar,
artificial sweeteners, caffeine (including coffee, decaf coffee,
black tea, soda/diet soda), fruit juices, and caffeine. In some
embodiments, only one additional food item is introduced to the
regimen and no other additional items are introduced for about
three days to about five days. In some embodiments, one or more
additional items are introduced to the regimen, after about three
days to about five days of introducing the only one additional
item.
[0274] In some embodiments, the diet plan is associated with a
myriad of improved physiological outcomes, which include, but are
not limited to, increase in urine output, increase in the number of
daily bowel movements, decrease in blood sugar, blood pressure, and
cholesterol levels, increased energy, weight loss, decrease in need
for prescription medication, decrease in insulin requirements,
better sleep habits, rested feeling upon rising, overall better
sense of well-being, subsiding and or complete elimination of
various other negative symptoms.
[0275] In some embodiments, the diet plan or regimen comprising
administration of the compositions described herein may be
associated with decreased blood sugar, blood pressure and
cholesterol levels. In some embodiments, the reduction of blood
sugar levels are indicated by, low glucometer reading,
irritability, light-headedness, sweating, brain fog or confusion,
shakiness, fatigue, lethargy, nervousness, anxiety, confusion,
rapid heartbeat or pulse, nausea, hunger, tingling or numbness in
the lips or tongue, lack of coordination, nightmares or crying out
during sleep, seizures, or unconsciousness. In some embodiments,
the individual following the regimens described herein, by
consumption of the compositions described herein, experiencing low
blood sugar levels, is recommended to consult a medical
practitioner, to manage and normalize the blood sugar levels. In
some embodiments, the blood sugar levels are managed and normalized
by food intake in frequent intervals. In some embodiments, the
frequent interval is between about 2 hr to about 3 hr. In some
embodiments, the blood sugar levels are managed and normalized by
altering the dose of blood sugar medicine. In some embodiments, the
blood sugar medicine is Insulin. In some embodiments, the blood
sugar levels are managed and normalized by eating a health snack or
a meal. In some embodiments, the blood sugar medicine is Insulin.
In some embodiments, the blood sugar levels are managed and
normalized by eating food items that raise blood sugar levels
rapidly.
[0276] In some embodiments, the reduction of blood pressure levels
are indicated by symptoms comprising headaches, fatigue, lethargy,
lowered body temperature, chill or cold feeling, or dizziness. In
some embodiments, the individual following the regimens described
herein, by consumption of the compositions described herein, is
recommended to monitor his or her blood pressure levels at regular
intervals. In some embodiments, the individual following the
regimens described herein, by consumption of the compositions
described herein, experiencing low blood pressure levels, is
recommended to consult a medical practitioner, to manage and
normalize the blood pressure levels. In some embodiments, the
reduction of cholesterol levels are indicated by symptoms
comprising, cognitive changes, depression, mood changes, behavioral
changes, suicidal tendencies, or sexual dysfunction. In some
embodiments, the individual following the regimens described
herein, by consumption of the compositions described herein,
experiencing lower than optimal cholesterol levels, is recommended
to consult a medical practitioner, to manage and normalize the
cholesterol levels.
[0277] In some embodiments, the regimen or diet plan is a metabolic
cleansing program, also known as a detoxification program. In some
embodiments, symptoms that are consistent with detoxification may
be observed. In some embodiments, the symptoms consistent with
detoxification comprise headaches, skin breakouts, gas, increased
bowel movements, body aches, bloating, irritability, brain fog,
fatigue/low energy, food cravings, constipation, diarrhea, or a
combination thereof. In some embodiments, these symptoms subside in
a few days. In some embodiments, the symptoms listed above may be
previously existing, prior to starting the regimen.
[0278] In some embodiments, the gas or bloating, constipation,
and/or diarrhea may be managed by adhering to one or more of the
following recommendations:
[0279] Ensuring enough intake of water to stay well hydrated.
[0280] Ensuring that the dietary recommendations are being followed
as close to 100% as possible.
[0281] Reading ingredient labels to make sure you are not consuming
anything that is restricted with the regimen.
[0282] Consuming high quality source of fiber in nutritional
supplement form. Fiber can add bulk to the stool and can be
effective in relieving diarrhea.
[0283] Reducing the dosage of the compositions described herein by
about 50% to about 75%.
[0284] If a reduction of 75% of the original dose does not cause
the symptoms to significantly reduce to a tolerable level or reduce
them completely stopping consumptions of the compositions described
herein for a few days, while continuing the other dietary
recommendations.
[0285] Eliminating any new dietary items that the individual was
not eating prior to starting the regimen, and only introduced to
his or her diet as part of the regimen.
[0286] If after eliminating those foods the gas and bloating are
reduces to a tolerable level or are eliminated completely the
individual following the regimen is recommended to add the
eliminated foods back one at a time to identify the offending
food.
[0287] If the gas and bloating were present prior to starting the
regimen it is likely to subside in a few days to about a week as
the system rebalances.
[0288] If any negative symptom persists for longer than 7 days or
progresses and the above steps have been taken with no improvement
it is recommended to discontinue the program all together and
consult a health care provider.
[0289] Exemplary Indications
[0290] Provided herein are methods, formulations and kits
comprising dietary supplements for administration to a subject that
may be suffering from one or more indications described herein.
Exemplary indications that can be treated, supported, prevented or
cured by a method, composition, formulation, or kit comprising
dietary supplements described herein are stated or enumerated
throughout this description. Certain exemplary indications are
discussed in further depth below.
[0291] For instance, disclosed herein are methods, formulations and
kits for administration to an individual diagnosed with diabetes
and/or complications associated with diabetes.
[0292] Diabetes: Diabetes mellitus is a metabolic disorder
characterized by hyperglycemia and disturbances of carbohydrate,
protein and fat metabolisms or relative lack of the hormone
insulin. Diabetes mellitus, often simply referred to as diabetes,
is a group of metabolic diseases in which a person has high blood
sugar, either because the body does not produce enough insulin or
because cells do not respond to the insulin that produce enough
insulin or because cells do not respond to the insulin that is
produced. This high blood sugar produces the classical symptoms of
polyuria (frequent urination), polydipsia (increased thirst) and
polyphagia (increased hunger).
[0293] Types of Diabetes: Type I diabetes is characterized by loss
of the insulin-producing beta cells of the islets of Langerhans in
the pancreas leading to insulin deficiency. This type of diabetes
is further classified as immune-mediated or idiopathic. The
majority of type I diabetes is of the immune-mediated nature, where
beta cell loss is a T-cell mediated autoimmune attack. There is no
known preventive measure against type I diabetes, which causes
approximately 10% of diabetes mellitus cases in North America and
Europe. Most affected people are otherwise healthy and of a healthy
weight when onset occurs. Sensitivity and responsiveness to insulin
are usually normal, especially in the early stages. Type I diabetes
affects children or adults but was traditionally termed "juvenile
diabetes" because it represents a majority of the diabetes cases in
children. Type II diabetes is characterized by insulin resistance
which may be combined with relatively reduced insulin secretion.
The defective responsiveness of body tissues to insulin is believed
to involve the insulin receptor. However, the specific defects are
not known. Diabetes mellitus due to a known defect are classified
separately. Type II diabetes is the most common type. In the early
stage of type II diabetes, the predominant abnormality is reduced
insulin sensitivity. At this stage hyperglycemia can be reversed by
a variety of measures and medications that improve insulin
sensitivity or reduce glucose production by the liver. Type II
diabetes, is believed to develop when: the receptors on cells in
the body that normally respond to the action of insulin fail to be
stimulated by it (insulin resistance). In response to this more
insulin may be produced, and this over-production exhausts the
insulin-manufacturing cells in the pancreas; insufficient insulin
available; and the insulin that is available may be abnormal and
therefore doesn't work properly. In certain embodiments, methods,
formulations and kits described herein are useful for support
and/or treatment of an individual suffering from diabetes. In
certain embodiments the diabetes is type I diabetes. In some cases,
the individual is diagnosed to type II diabetes. In certain
embodiments, the individual is identified as pre-disposed to
diabetes. In certain instances, the predisposition is societal or
genetic.
[0294] Complications associated with diabetes: In certain
embodiments, methods, formulations and kits described herein are
useful for support and/or treatment of an individual demonstrating
or diagnosed with complications associated with diabetes.
[0295] Skin complications: diabetes affects every part of the body,
including the skin. In fact, such problems are sometimes the first
sign that a person has diabetes. These include bacterial
infections, fungal infections, and itching. Other skin problems
happen mostly or only to people with diabetes. These include but
are not limited to acanthosis nigricans, diabetic dermopathy,
necrobiosis lipoidica diabeticorum, diabetic blisters, eruptive
xanthomatosis, digital sclerosis, and disseminated granuloma
annulare. Diabetes can cause changes in the skin of the feet. At
times the feet may become very dry. The skin may peel and crack. In
certain cases, the nerves that control the oil and moisture in the
feet are no longer functioning. In certain embodiments, methods,
formulations and kits described herein are useful for support
and/or treatment of an individual suffering from skin complications
associated with diabetes.
[0296] Eye complications: these include glaucoma (people with
diabetes are 40% more likely to suffer from glaucoma than people
without diabetes), cataracts (people with diabetes are 60% more
likely to develop cataract), retinopathy (including
nonproliferative retinopathy, macular edema, and proliferative
retinopathy). In certain embodiments, methods, formulations and
kits described herein are useful for support and/or treatment of an
individual suffering from eye complications associated with
diabetes.
[0297] Neuropathy (nerve damage): nerve damage from diabetes is
called diabetic neuropathy.
[0298] About half of all people with diabetes have some form of
nerve damage. It is more common in those who have had the disease
for a number of years and can lead to many kinds of problems. If
the blood glucose levels are kept on target, it may help prevent or
delay nerve damage. Although it can hurt, diabetic nerve damage can
also lessen the ability to feel pain, heat, and cold. Loss of
feeling often means the patient may not feel a foot injury. Nerve
damage can also lead to changes in the shape of the feet and toes.
In certain embodiments, methods, formulations and kits described
herein are useful for support and/or treatment of an individual
suffering from neuropathy.
[0299] Foot complications: such as calluses, foot ulcers, poor
circulation or amputation. Calluses occur more often and build up
faster on the feet of people with diabetes. Foot ulcers occur most
often on the ball of the foot or on the bottom of the big toe.
Ulcers on the sides of the foot are usually due to poorly fitting
shoes. People with diabetes are far more likely to have a foot or
leg amputated than other people. Many people with diabetes have
peripheral arterial disease (PAD), which reduces blood flow to the
feet. Also, many people with diabetes have nerve disease, which
reduces sensation. Together, these problems make it easy to get
ulcers and infections that may lead to amputation. In certain
embodiments, methods, formulations and kits described herein are
useful for support and/or treatment of an individual suffering from
or at risk of foot complications that may be associated with
diabetes.
[0300] Diabetic ketoacidosis (DKA): Diabetic ketoacidosis (DKA) is
a serious condition that can lead to diabetic coma (passing out for
a long time) or even death. When the cells don't get the glucose
they need for energy, the body begins to burn fat for energy, which
produces ketones. Ketones are acids that build up in the blood and
appear in the urine when the body doesn't have enough insulin. They
are a warning sign that the diabetes is out of control. High levels
of ketones can poison the body. In certain embodiments, methods,
formulations and kits described herein are useful for support
and/or treatment of an individual suffering from or at risk of
diabetic ketoacidosis.
[0301] Kidney disease (Nephropathy): Inside kidneys are millions of
tiny blood vessels that act as filters. Their job is to remove
waste products from the blood. Sometimes this filtering system
breaks down. Diabetes can damage the kidneys and cause them to
fail. Failing lose their ability to filter out waste products,
resulting in kidney disease. Diabetes can damage this system. High
levels of blood sugar make the kidneys filter too much blood. All
this extra work is hard on the filters. After many years, they
start to leak and useful protein is lost in the urine. Having small
amounts of protein in the urine is called microalbuminuria. In
certain embodiments, methods, formulations and kits described
herein are useful for support and/or treatment of an individual
suffering from or at risk of kidney disease.
[0302] High blood pressure (Hypertension): nearly 1 in 3 American
adults has high blood pressure and 2 in 3 people with diabetes
report having high blood pressure or take prescription medications
to lower their blood pressure. The heart has to work harder when
blood pressure is high, and the risk for heart disease, and other
problems goes up. In certain embodiments, methods, formulations and
kits described herein are useful for support and/or treatment of an
individual suffering from or at risk of high blood pressure.
[0303] Hyperosmolar Hyperglycemic Nonketotic Syndrome (HHNS): this
is a serious condition most frequently seen in older persons. HHNS
can happen to people with either type 1 or type 2 that is not being
controlled properly, but it occurs more often in people with type
2. HHNS is usually brought on by something else, such as an illness
or infection. In HHNS, blood sugar levels rise, and the body tries
to get rid of the excess sugar by passing it into the urine. Lots
of urine is made at first, and the patient has to go to the
bathroom more often. Later the patient may not have to go to the
bathroom as often, and the urine becomes very dark. Also, the
patient may be very thirsty. If HHNS continues, the severe
dehydration will lead to seizures, coma and eventually death. HHNS
may take days or even weeks to develop. In certain embodiments,
methods, formulations and kits described herein are useful for
support and/or treatment of an individual suffering from or at risk
of HHNS.
[0304] Gastroparesis: Disorder affecting people with both type 1
and type 2 diabetes in which the stomach takes too long to empty
its contents (delayed gastric emptying). The vagus nerve controls
the movement of food through the digestive tract. If the vagus
nerve is damaged or stops working, the muscles of the stomach and
intestines do not work normally, and the movement of food is slowed
or stopped. Just as with other types of neuropathy, diabetes can
damage the vagus nerve if blood glucose levels remain high over a
long period of time. High blood glucose causes chemical changes in
nerves and damages the blood vessels that carry oxygen and
nutrients to the nerves. In certain embodiments, methods,
formulations and kits described herein are useful for support
and/or treatment of an individual suffering from or at risk of
gastroparesis.
[0305] Heart diseases: People with diabetes have a
higher-than-average risk of having a heart attack or stroke. These
strike people with diabetes more than twice as often as people
without diabetes. There's a big link between diabetes, heart
disease, and stroke. In fact, two out of three people with diabetes
die from heart disease or stroke, also called cardiovascular
disease. Clogged blood vessels can lead to heart attack, stroke,
and other problems. But there are treatments for heart disease,
stroke, and blood vessel disease. In certain embodiments, methods,
formulations and kits described herein are useful for support
and/or treatment of an individual suffering from or at risk of
heart diseases.
[0306] Inflammation: People with type 2 diabetes don't produce
enough insulin or their bodies can't use the insulin adequately.
Insulin may also have an impact on tissue in the body. Its effects
on tissue are influenced by many factors, including obesity and the
accumulation of fat around the belly and on major organs in the
abdomen. The fat cells can produce chemicals that lead to
inflammation. Scientists are only beginning to understand the role
this form of internal inflammation may play in the development of
chronic diseases like diabetes. In certain embodiments, methods,
formulations and kits described herein are useful for support
and/or treatment of an individual suffering from or at risk of
inflammation.
[0307] Mental health: People with diabetes often deal with natural
emotions like stress, sadness, anger and denial before they lead to
depression. In certain embodiments, methods, formulations and kits
described herein are useful for support and/or treatment of an
individual suffering from or at risk of mental health issues.
[0308] Disclosed herein are methods, formulations and kits for
treating skin complications resulting from diabetes. Disclosed
herein are methods, formulations and kits for treating eye
complications resulting from diabetes. Disclosed herein are
methods, formulations and kits for treating neuropathy resulting
from diabetes. Disclosed herein are methods, formulations and kits
for treating foot complications resulting from diabetes. Disclosed
herein are methods, formulations and kits for treating diabetic
ketoacidosis. Disclosed herein are methods, formulations and kits
for treating kidney disease resulting from diabetes. Disclosed
herein are methods, formulations and kits for treating high blood
pressure resulting from diabetes. Disclosed herein are methods,
formulations and kits for treating hyperosmolar hyperglycemic
nonketotic syndrome resulting from diabetes. Disclosed herein are
methods, formulations and kits for treating gastroparesis resulting
from diabetes. Disclosed herein are methods, formulations and kits
for treating heart disease resulting from diabetes. Disclosed
herein are methods, formulations and kits for treating mental
diseases resulting from diabetes. Disclosed herein are methods,
formulations and kits for treating inflammation resulting from
diabetes.
[0309] High cholesterol: Abnormal cholesterol levels
(hypercholesterolemia)--higher concentrations of LDL particles and
lower concentrations of functional HDL particles--are strongly
associated with cardiovascular disease because these promote
atheroma development in arteries (atherosclerosis). This disease
process leads to myocardial infarction (heart attack), stroke, and
peripheral vascular disease. Since higher blood LDL, especially
higher LDL particle concentrations and smaller LDL particle size,
contribute to this process more than the cholesterol content of the
HDL particles, LDL particles are often termed "bad cholesterol"
because they have been linked to atheroma formation. On the other
hand, high concentrations of functional HDL, which can remove
cholesterol from cells and atheroma, offer protection and are
sometimes referred to as "good cholesterol". These balances are
mostly genetically determined, but can be changed by body build,
medications, food choices, and other factors. Disclosed herein are
methods, formulations and kits for treating high cholesterol and
complications resulting from high cholesterol.
[0310] It is understood that the examples and embodiments described
herein are for illustrative purposes only and that various
modifications or changes in light thereof will be suggested to
persons skilled in the art and are to be included within the spirit
and purview of this application and scope of the appended
claims.
EXAMPLES
[0311] It is understood that the examples and embodiments described
herein are for illustrative purposes only and that various
modifications or changes in light thereof will be suggested to
persons skilled in the art and are to be included within the spirit
and purview of this application and scope of the appended
claims.
[0312] The reagents employed in the examples are commercially
available or can be prepared using commercially available
instrumentation, methods, or reagents known in the art. The
foregoing examples illustrate various aspects of the invention and
practice of the methods of the invention. The examples are not
intended to provide an exhaustive description of the many different
embodiments of the invention. Thus, although the forgoing invention
has been described in some detail by way of illustration and
example for purposes of clarity of understanding, those of ordinary
skill in the art will realize readily that many changes and
modifications can be made thereto without departing from the spirit
or scope of the appended claims.
Example 1
[0313] Formulations and diet plans described herein were
administered to 311 individuals, to assess the effect of a diet
comprising the formulations described herein, on biological markers
and other parameters indicative of blood glucose control. Blood
levels were measured, before and after the administration of
formulations and diet plans described herein, for the following
biological markers: glycated hemoglobin (HbA1C), total cholesterol,
triglycerides, homocysteine, C-reactive protein (CRP), vitamin D.
Other parameters that were monitored before and after the
administration of formulations and diet plans described herein
included overall weight Change, requirement for oral diabetes
medications and/or insulin injections.
[0314] Out of the 311 participants, 152 (about 48%) were fully
compliant with proper administration of formulations and diet plans
described herein, for the entire duration of the study. The average
change in the biological markers assessed are listed in Table
1.
TABLE-US-00004 TABLE 1 Biological Markers before and after
administration Biological Marker Average Change in Blood Levels
HbA1C 17% reduction Total Cholesterol 3.2% reduction Triglycerides
30% reduction Homocysteine 10% reduction C-reactive protein 5%
increase Vitamin D 70% increase
[0315] The total number of participants, who experienced reduction
in oral and parenteral (insulin) diabetic medication requirements,
are listed below in Table 2.
TABLE-US-00005 TABLE 2 Diabetic medication requirements before and
after administration of formulations and diet plans described
herein Number of Participants/% Parameter of Compliant Participants
Off Oral Medication 85/(55%) Off Insulin Injections 32/(21%)
Participant became Non-Diabetic 85/(55%) at the end of the
Study
[0316] The study participants also experienced varying degrees of
weight loss, and the results, grouped according to starting weights
are shown below, in Table 3.
TABLE-US-00006 TABLE 3 Weight loss after Life Support Diet Starting
Weight Range Final Weight Range Average Weight Loss 300-350 lbs.
280-320 lbs. 40 lbs. 250-300 lbs. 190-260 lbs. 31 lbs. 200-250 lbs.
150-240 lbs. 24 lbs. 135-200 lbs. 120-190 lbs. 16 lbs.
[0317] Collectively, the clinical study indicated that
administration of a formulation described herein optionally
combined with a diet plan described herein resulted in significant
improvement in management of a wide range of conditions associated
with type 11 diabetes.
Example 2--Case Studies on Type II Diabetes Patients
[0318] The following examples describe case studies of six
participants, who experienced remarkable improvements in diabetes
and other associated conditions, after being on the regimen, by
administration of the compositions described herein.
[0319] Study Goals: The primary goal of the study was to assess the
effects of administering a composition described herein, using
methods described herein, on the overall glucose homeostatis in the
participant. Secondary goals included monitoring blood levels of
other markers associated with improper glucose homeostasis.
[0320] Study Design and Assessment: The participants were
administered with at least one formulation or composition described
herein, and blood marker levels were assessed before beginning
administration and after being in a method or regimen comprising
administration of at least one formulation for various lengths of
time.
[0321] Participant No. 1:
[0322] Clinical Background of Participant: The participant had a
family history of diabetes, elevated blood glucose levels and was
under various medications to manage cardiovascular, endocrinal,
digestive, and ocular issues.
[0323] The participant was diagnosed to have impairment in the
following mechanisms, as a result of hyperglycemia: dysglycemia,
inflammation, viral infection pattern, adrenal fatigue, hippocampus
dysfunction, dysregulation of hypothalamic-pituitary-adrenal axis,
vitamin D deficiency, and intestinal dysbiosis.
[0324] Formulations described herein were administered to the
individual. The following ingredients were to address dysglycemia
were present in one or more formulations administered to the
individual:
[0325] Gymnema Sylvestre: The natural substance has demonstrated
positive impacts in managing and supporting insulin resistance
patterns. Specifically, it has been associated with a reduction in
insulin requirements, decrease fasting blood sugar, enhance the
action of insulin, aid in the regeneration of pancreatic beta
cells, thereby correcting insulin resistance.
[0326] Chromium: Chromium levels are known to play a role in
insulin resistance. In view of that knowledge, chromium was
included in the compositions described herein, to improve insulin
resistance. The mineral was found to increases the health and
sensitivity of the receptor sites, resulting in better transport of
glucose molecules across the cell membrane, and utilization of
glucose for energy production, in the form of ATP.
[0327] Vanadium: This was also a critical mineral included in the
compositions described herein, for managing insulin resistance.
[0328] Alpha Lipoic acid: This ingredient was also included in the
compositions described herein, as it is known to improve insulin
resistance by increasing activation of glucose transporter 1 and 4
which enhance glucose disposal by sensitizing tissues to insulin
and by restoring proper intracellular redox states which then reset
signalling and response to insulin.
[0329] Banaba Leaf Extract: The natural substance, containing
triterpenoid, lager stroemin, flosin B, reginin A, and corosolic
acid, which have been shown to help regulate glucose levels, was
included in the compositions described herein, to produce glucose
lowering effects by enhancing peripheral glucose utilization.
[0330] Bitter Melon: The popular plant used worldwide to support
patients with diabetes.
[0331] Vitamin D: Blood levels of the prohormone Vit. D have been
shown to be very important in blood sugar metabolism, insulin
receptor site activity, immune function, cardiovascular health,
bone health, reduced risk of some forms of cancer, musculoskeletal
pain, preventative role in Type 1 diabetes, and some
neurodegenerative disease etc.
[0332] In addition, to manage intestinal dysbiosis, probiotic
therapy was carried out. The supplementation of probiotics has been
shown to facilitate and normalize healthy gut flora. Unhealthy gut
flora (intestine dysbiosis) has been associated with intestinal
permeability, malabsorption, irritable bowel disease, inflammatory
bowel disease, reduced immune function, digestive distress etc.
[0333] Table 4, shows the blood levels of selected markers,
measured before and after six weeks of administering the
compositions described herein, to participant no. 1, using the
methods described herein.
TABLE-US-00007 TABLE 4 Prior to After six weeks of administration
of administration of Blood Marker Claimed Compositions Claimed
Compositions HbA1c (glycated 7.2 6.4 hemoglobin) Total Cholesterol
126 mg/dL 108 mg/dL Vitamin D 34.1 ng/mL 64.7 ng/mL Absolute
Lymphocyte 3.5 2.3 Count
[0334] Apart from the blood work results listed above, the
participant also experienced the following quality of life
improvements:
[0335] A weight loss of 15 lbs. without any exercise, which
indicated that the glucose metabolism was returning to
homeostasis.
[0336] A reduction in the amount of prescription medication was
observed within a month of being on the Life Support regimen,
carried out by administration of the composition described
herein.
[0337] Increased energy levels were observed within a month of
being on the Life Support regimen, carried out by administration of
the composition described herein.
[0338] An improvement in eyesight, verified by an ophthalmologist,
was observed within a month and a half of administration of the
composition described herein.
[0339] Complete elimination of peripheral neuropathy and numbness
in both feet, was observed within four months of being on the Life
Support regimen, carried out by administration of the composition
described herein.
[0340] The reduction in weight achieved only by administration of
the compositions described herein, without any exercise was
beneficial and especially helpful for people who have medical
restrictions and are not advised exercise. The glycated hemoglobin
levels were indicative of a reversal from diabetic to pre-diabetic
state. The reduction in lymphocyte count indicated that the immune
system responded to the administration of compositions described
herein, and the viral infection pattern was also ameliorated.
[0341] Participant No. 2:
[0342] Clinical Background of Participant: The participant suffered
from Type II diabetes and was under insulin medication, at a dosage
of 20-30 units, four times a day.
[0343] The participant was diagnosed to have irregularities in the
following mechanisms, as a result of hyperglycemia: dysglycemia,
inflammation, liver dysfunction, fatty liver, intestinal
dysbiosis.
[0344] The participant was administered formulations described
herein. The following ingredients were present in one or more
formulations administered to the participant:
[0345] Magnesium: It improved insulin resistance by optimizing
insulin secretion, activating glucose transport for insulin
mediated glucose uptake.
[0346] Biotin: It improved insulin response to glucose load,
lowered post-prandial glucose levels, and upregulated the enzyme
glucokinase, which is responsible for the first step in glucose
utilization by the liver.
[0347] Glutathione and Superoxide dismutase: One of the most
powerful antioxidants known to the human species, thus very
important in the management of inflammation. The status of
glutathione is considered the single most accurate indicator of the
health of a cell.
[0348] Blood sugar disorders deplete both nutrients. Also important
for heart health, liver detox, immune modulation, fatty liver and
other conditions.
[0349] Carnitine, choline, inositol, taurine, L-methionine, and
N-acetyl cysteine promote the synthesis of phospholipids which are
the building blocks of the lipoprotein used to transport lipids out
of the liver.
[0350] Table 5, shows the blood levels of selected markers,
measured before and after six weeks of administering the
compositions described herein, to participant no. 2, using the
methods described herein.
TABLE-US-00008 TABLE 5 Prior to After six weeks of administration
of administration of Blood Marker Claimed Compositions Claimed
Compositions HbA1c (glycated 8.4 6.9 hemoglobin) Alanine
Aminotrans- 49 IU/L 22 IU/L ferase (Liver Enzyme) Triglycerides 243
mg/dL 179 mg/dL Total Cholesterol 170 mg/dL 146 mg/dL VLDL (Very
Low 49 mg/dL 36 mg/dL Density Lipoprotein) C-Reactive Protein 4.14
mg/dL 1.94 mg/dL Vitamin D 29.7 ng/dL 60 g/dL
[0351] Apart from the blood work results listed above, the
participant also experienced quality of life improvements, some of
which are outlined in FIG. 1A:
[0352] Reduction of Insulin from 30 units daily to 10 units daily.
On certain days, no Insulin administration was needed, based on the
low blood glucose readings.
[0353] Increased energy levels were observed within a week of being
on the Life Support regimen, carried out by administration of the
composition described herein.
[0354] Pain in joints and symptoms of restless legs were reduced
within a month of being on the Life Support regimen, carried out by
administration of the composition described herein.
[0355] A weight loss of 25 lbs. without any exercise, which
indicated that the glucose metabolism was returning to
homeostasis.
[0356] Participant No. 3:
[0357] Clinical Background of Participant: The participant suffered
from Type II diabetes and was under insulin medication, about six
to seven times per day.
[0358] The participant was diagnosed to have impairment in the
following mechanisms, as a result of hyperglycemia: adrenal gland
dysfunction, dysregulation of the HPA axis, evidence suggesting
deterioration of hippocampus. Saliva test performed on samples from
the participant indicated adrenal stress index which is
characterized by excess cortisol production and hippocampal
dysfunction.
[0359] Formulations described herein were provided to the
participant. One or more formulations comprising the following
ingredients were administered:
[0360] Ashwagandga root: The natural substance has adaptogenic
properties, which imparts it with a capability of dealing with
adrenal dysfunction at times of high as well as low function. The
glucocorticoid activity makes it helpful in adrenal stress
syndrome. It also has the ability to counteract some of the adverse
physical responses to stress such as changes in blood sugar
metabolism.
[0361] Holy basil leaf extract: Studies have shown that the holy
basil prevents the increased plasma levels of cortisol induced
exposure to both chronic and acute stress, supports normal blood
sugar levels, modulates HPA activity etc.
[0362] Rhodiola: It is an adaptogenic plant that has demonstrated
Central Nervous system enhancement, anti-depressant properties,
anti-carcinogenic properties, and cardioprotective properties.
[0363] Pantethine and/or Pantothenic Acid: An important nutrient in
stress conditions. It has demonstrated the ability to down regulate
the exaggerated secretion of cortisol under times of stress as well
as the ability to support adrenal cortical functions when
needed.
[0364] Phosphatidylserine: Has shown the ability to enhance
cellular metabolism and communication, protect cells from oxidative
damage, decrease anxiety, improve mood, motivation and depression,
enhance memory and cognition, and decrease cortisol. Its activity
in decreasing cortisol makes it an important factor in
rehabilitating the hippocampus
[0365] Table 6, shows the blood levels of selected markers,
measured before and after six weeks of administering the
compositions described herein, to participant no. 4, using the
methods described herein.
TABLE-US-00009 TABLE 6 Prior to After six weeks of administration
of administration of Blood Marker Claimed Compositions Claimed
Compositions Triglycerides 199 mg/dL 169 mg/dL Total Cholesterol
195 mg/dL 143 mg/dL LDL (Low Density 116 mg/dL 78 mg/dL
Lipoprotein)
[0366] Apart from the blood work results listed above, the
participant also experienced the following quality of life
improvements, some of which are noted in FIG. 1B:
[0367] The patient did not have to continue taking any prescription
drugs after two months of being on the regimen.
[0368] The insulin dosage was reduced within a month, when the
patient needed to take only one insulin dose at night.
[0369] There was also significant reduction in foot pain,
indicative of amelioration of diabetic neuropathy, within two
months.
[0370] A total weight loss of 20 lbs, with no exercise, which
indicated that the glucose metabolism was returning to
homeostasis.
[0371] Participant No. 4:
[0372] Clinical Background of Participant: The participant suffered
from Type II diabetes and presented with very high glucose in
hemoglobin levels.
[0373] Table 7, shows the blood levels of selected markers,
measured before and after six weeks of administering the
compositions, to participant no. 4, described herein, using the
methods described herein.
TABLE-US-00010 TABLE 7 Prior to After six weeks of administration
of administration of Blood Marker Claimed Compositions Claimed
Compositions HbA1c (glycated 9.1 7.6 hemoglobin) Vitamin D 13.2
ng/dL 62.7 ng/dL
[0374] Apart from the blood work results listed above, the
participant also experienced the following quality of life
improvements, some of which are outlined in FIG. 1C:
[0375] The patient was able to eliminate all cholesterol
medications within 2 months and began feeling better immediately
after starting the regimen.
[0376] Insulin needs were reduced within one week.
[0377] The blood sugar levels were reduce from 300 mg/dL to an
average of 105 mg/dL concurrently with reduction and elimination
with the need for Insulin.
[0378] A total weight loss of 10 lbs, in one and half months, with
no exercise, which indicated that the glucose metabolism was
returning to homeostasis.
[0379] Participant No. 5:
[0380] Table 8, shows the blood levels of selected markers,
measured before and after six weeks of administering the
compositions described herein, to participant no. 5, using the
methods described herein.
TABLE-US-00011 TABLE 8 Prior to After six weeks of administration
of administration of Blood Marker Claimed Compositions Claimed
Compositions Glucose 326 mg/dL 181 mg/dL HbA1c (glycated 14.8 10.8
hemoglobin) Vitamin D 13.2 ng/dL 62.7 ng/dL Triglycerides 3504
mg/dL 209 mg/dL Total Cholesterol 564 mg/dL 194 mg/dL LDH (lactic
289 IU/L 133 IU/L dehydrogenase) GGT (Liver Enzyme) 78 IU/L 41 IU/L
(amelioration of fatty liver pattern) C-Reactive Protein 6.5 mg/L
3.42 mg/L Glucose in Urine 3+ Trace Ketones in Urine 2+
Negative
[0381] Participant No. 6:
[0382] Clinical Background of Participant: The participant suffered
from Type II diabetes and had a heart surgery just before starting
a regimen using the compositions described herein. The patient was
taking over 300 units on Insulin daily, with no improvement in
blood glucose management.
[0383] Table 9, shows the blood levels of selected markers,
measured before and after six weeks of administering the
compositions described, herein to participant no. 6, using the
methods described herein.
TABLE-US-00012 TABLE 9 Prior to After six weeks of administration
of administration of Blood Marker Claimed Compositions Claimed
Compositions HbA1c (glycated 8.4 6.3 hemoglobin) Aspartate
Aminotrans- 63 IU/L 22 U/L ferase (Liver Enzyme) Alanine
Aminotrans- 79 U/L 23 U/L ferase (Liver Enzyme) Triglycerides 182
mg/dL 95 mg/dL LDH (lactic 289 IU/L 133 IU/L dehydrogenase) GGT
(Liver Enzyme) 78 IU/L 41 IU/L (amelioration of fatty liver
pattern) C-Reactive Protein 6.5 mg/L 3.42 mg/L Glucose in Urine 3+
Trace Ketones in Urine 2+ Negative
[0384] Apart from the blood work results listed above, the
participant also experienced the following quality of life
improvements:
[0385] The patient was able to completely eliminate insulin,
lisinopril, cozaar, omeprazole, HCTZ, byetta, and synthroid.
[0386] The only medication that the patient had to continue taking
was metformin, but only half of the usual dose.
[0387] A total weight loss of 150 lbs, in one and half months, with
no exercise, which indicated that the glucose metabolism was
returning to homeostasis.
[0388] Summary of Case Studies:
[0389] The Type 2 diabetes patients using formulations, methods
and/or kits described herein, prepared using dietary supplements
that were carefully constructed to deal with the underlying
mechanisms that cause diabetes, were shown to have desirable and
positive clinical outcomes.
[0390] It is to be understood that the terminology used herein is
used for the purpose of describing specific embodiments, and is not
intended to limit the scope of the present invention. It should be
noted that as used herein, the singular forms of "a", "an" and
"the" include plural references unless the context clearly dictates
otherwise. In addition, unless defined otherwise, all technical and
scientific terms used herein have the same meaning as commonly
understood by one of ordinary skill in the art to which this
invention belongs.
[0391] While preferable embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
* * * * *