Title: Composition and method for reducing blood glucose
United States Patent: 6,884,420
Issued: April 26, 2005
Inventors: See; Darryl (Laguna Niguel, CA)
Assignee: Cross Bay, LLC (Las Vegas, NV)
Appl. No.: 440110
Filed: May 19, 2003
A composition for reducing blood sugar in humans in need thereof,
contains Agaricus blazeii, alpha lipoic acid, transfer factor, polymannose,
fenugreek, coenzyme Q-10, selenium, zinc, vitamin C, vitamin E, chromium and
Description of the Invention
BACKGROUND OF THE INVENTION
The invention relates to the field of compositions for treatment of
diabetes, either type II (non-insulin dependent diabetes) or type I
Diabetes Mellitus (DM) is the most common chronic degenerative disease in
the world. In the US alone, it is the third leading cause of disease,
accounts for over 10% of all hospitalizations and costs our health care
system over 20 billion dollars per year. Some populations, such as
Hispanics, Native Americans and the southern Africans, have a prevalence of
over 30%. Despite advances in treatment, complications such as heart
disease, renal failure, glaucoma, blindness, chronic ulcers, painful
neuropathy, Charcot's joints and amputations will occur at a high rate as a
result of chronically elevated serum blood glucose levels.
There are two forms of diabetes, Type I and Type II. Type I, or
insulin-requiring, is characterized by autoimmune destruction of the
insulin-producing islet cells in the pancreas. Molecular mimicry with
certain viruses such as coxsackieviruses and other antigens such as those
found in milk may be the cause. Glutamate decarboxylase on the target islet
cell may be the binding site for the cross-reacting immune cells. Lack of
insulin leads to an excess of glucose in the blood and resultant
complications such as heart and kidney disease.
Type II DM is characterized by cellular resistance to insulin, once again
resulting in high blood glucose levels. The mechanism of Type II DM is
multifactorial. Thus, immunological abnormalities have been found, viruses
have been implicated, target cells have insulin resistance, weight is an
important factor, the pancreas underproduces insulin, and high blood sugar
causes cellular dysfunction in many organ systems. Furthermore,
complications lead to considerable mortality and morbidity.
The therapy for Type I DM is insulin replacement, but either too high or too
low of a dose can lead to disastrous complications like diabetic coma and
heart attacks. Administration of insulin also accelerates the aging process
in cells and tissues, it speeds up plaque production on coronary arteries,
it can actually raise blood sugar levels, it can block DNA, RNA, protein and
glucose synthesis and it can result in central nervous system and
circulatory depression, even leading to death. Oral hypoglycemic agents can
cause nausea, diarrhea, fatigue, excess insulin levels, suppressed cellular
function, headaches, muscle aches, decreased concentration and rashes.
Type II DM can be treated with drugs that lower cellular resistance to
insulin and stimulate its release, but this approach may also lead to
toxicity from the medications.
A natural approach to DM would seem logical given the complications and
shortcomings of treatment with drugs and insulin. The normal body
homeostasis and feedback mechanisms can be maintained to restore normal
blood glucose and insulin levels; side effects are eliminated. The cost to
society may be lowered by reducing cost of treatment of both the disease and
also complications may be decreased.
SUMMARY OF THE INVENTION
It is therefore an object of the invention to provide a composition that
addresses the underlying mechanisms of diabetes mellitus.
To achieve this and other objects, the invention is directed to a
combination of herbs, minerals and natural components of the body, which
reduces blood sugar to lower levels on a consistent basis and may prevent
the mortality and morbidity of this disease, while being non-toxic and
without side effects. Thus, the components of the invention were selected to
lower blood sugar levels, insulin requirements and complications of diabetes
DETAILED DESCRIPTION OF THE INVENTION
The preferred composition of the invention contains, in percent by
weight, the following components in approximate amounts:
|alpha lipoic acid
Agaricus blazeii is a mushroom found in South America, Japan and
Korea. Various mushrooms of the Agaricaceae family are known to have insulin
potentiating activity, as disclosed for example in U.S. Pat. No. 6,200,569
to Cheng. The extract of this mushroom appears to regulate the immune
system, resulting in decreased immune-mediated damage from high glucose
levels and also improving resistance to infection.
Alpha-lipoic acid is a potent antioxidant is found in all cells in small
amounts, and is decreased in diabets patients. Oxidative stress is
responsible for many of the complications of diabetes and this cellular
component may decrease them. Moreover, as discussed in U.S. Pat. No.
5,948,810 to Wessel et al, it has been reported in the literature that R,S-(+,-)-alpha-lipoic
acid has a blood sugar-lowering effect in the case of alloxan-induced
diabetes in the animal model. In this connection, it has not been resolved
whether this effect due to interference with the secretion of insulin or
directly due to the activation of the pyruvate dehydrogenase (C. V. Natraj
et al., J. Biosci. vol. 6(1), 37-46 (1984)). Metabolic deviations resulting
from diabetes, such as hyperglycemia, ketonemia, ketonuria, reduced glycogen
in the tissue and a decreased synthesis of fatty acids in the liver are
corrected in animal experiments by the administration of lipoic acid (S. S.
Wagh, C. V. Natraj et al., J. Biosci. vol. 11, 59-74 (1987)).
Transfer factor is produced by leucocytes and lymphocytes, and comprises
small water soluble polypeptides of about eight amino acids and also
associated cofactors that stimulate or transfer cell mediated immunity from
one individual to another and across species. These immune system hormones
may balance the immune system and prevent it from damaging tissues in
diabetic patients. Since transfer factors are smaller than antibodies, they
do not transfer antibody mediated responses nor do they induce antibody
production. The properties, characteristics and processes for obtaining
transfer factor or transfer factors are discussed in U.S. Pat. Nos.
4,816,563, 5,080,895, 5,840,700, 5,883,224 and 6,506,413.
Polymannose is a long chain essential saccharide known to stimulate the
immune system and sold for example, as in a composition under the trade mark
"Manapol" by Carrington Laboratories. Polymannose is a component of the herb
aloe barbensis and glycosylates enzymes in the liver that are resonsibe for
glucose production (gluconeogenesis), which can be abnormal in diabetes
patients, thus lowering blood glucose levels and glucose production when the
liver senses they are too high. Furthermore, the mannose can glycosylate
cell mebrane glycoproteins important in insulin binding, leading to improved
cellular response to insulin.
Fenugreek, a slender annual herb of the pea family, may decrease cortisol
production in the body when it is too high, leading to lowered blood glucose
levels and complications of elevated cortisol such as accelerated aging and
heart disease. Its dried seeds have been used for generations as a food, a
flavoring, and a medicine. Steroidal saponins may account for many of the
beneficial effects of fenugreek, particularly the inhibition of cholesterol
absorption and synthesis. The seeds are rich in dietary fiber. The use of
fenugreek in a composition for treatment of diabetes is disclosed, for
example, in U.S. Pat. No. 6,451,355 to Reisner.
Co-enzyme Q-10 (ubiquinone) is a dietary supplement used to treat a variety
of problems. It is both an important antioxidant lowering oxidative stress
and is also crucial for normal heart function. Levels are decreased in
diabetes patients, and raising them may lower the risk of heart disease,
which is the number one killer in diabetics, and also lowers glucose
requirements in the heart, resulting in lower blood levels. U.S. Pat. No.
6,300,377 to Chopra discloses the use of a combination of ubiquinone and
alpha lipoic acid for treatment of diabetes.
The remaining components of the composition are known dietary supplements.
Selenium is crucial for many cellular functions and is deficient in
diabetics. Normalized levels may stimulate insulin production in type II
diabetics, and also may prevent complications in other tissues.
Vitamin C is crucial for multiple processes in the human body. It tends to
be deficient in diabetics and replacement appears to improve the active
transport of glucose from the bloodstream across the cell membrane into
Vitamin E is also deficient in diabetics. Restoring normal levels improves
antioxidant function and also enhances glucose transport across the cell
membrane by helping to normalize and upregulate insulin receptors.
Chromium is crucial in cell metabolism. Normalizing metabolism by restoring
normal levels decreases the need for glucose in cells, feeding back a
message to the pancreas to produce less insulin and the liver to produce
Vanadium is a trace mineral which is low in almost all diabetics. It can
lower blood sugar levels in all diabetics by enhancing glucose metabolism
inside the cells.
Zinc is a mineral necessary for proper immune function, and is deficient in
almost all diabetic patients, contributing to the complications.
Preferably, zinc is added as zinc glycinate, selenium as selenomethionine,
chromium as chromium picolinate, vanadium as vanadyl sulfate and vitamin E
as d-alpha-tocopherol succinate.
In a typical composition according to the invention, the components
described above are ground and formed into a tablet, optionally with
adjuvants as are known in the art. Each dose typically contains:
|alpha lipoic acid
|selenium (as selenomethionine)
|zinc (as zinc glycinate)
|vitamin C (as ascorbic acid)
|vitamin E (as d-α-tocopherol
|chromium (as chromium picolinate)
|vanadium (as vanadyl sulfate)
Confluent monolayers of murine islet, fat and hepatic cells were
periodically stimulated to produce glucose into the supernatant by
withholding Fetal Bovine Serum (FBS) in the presence of the typical
inventive composition above, individual components added at 1 h intervals
(50 μg/ml each) and no additive (negative control).
Results: supernatant blood sugar levels measured ½ h after sequentially
adding each component (90 min after withholding FBS) resulted in supernatant
glucose levels as follows:
p<0.01: there is less than 1 in 100 chance that the differences noted in
the study are random rather than based on the results of the medications
Use of the composition of the invention resulted in significantly lower
glucose levels produced by islet cells as compared to the individual
ingredients added sequentially. We attempted to duplicate real-life
conditions by continuous levels in the supernatant, as may be expected by
dosing all ingredients at the same time, versus adding the ingredients
sequentially, as may be the situation when a patient attempts to take the
ingredients throughout the day (which is the recommended method since taking
such a large number of supplements simultaneously is not feasible from a
gastrointestinal tolerability aspect). While not wishing to be held to any
particular explanation, it is theorized that the combination of components
work synergistically and simultaneously on hepatic, fat and islet cells to
produce lowered glucose levels while individual components lack synergy when
A 30 day study was conducted of 20 persons with type II DM according to the
Patients with documented type II diabetes mellitus were eligible. They
received the composition of the invention described above as the typical
composition in tablet form 3 times per day, while reducing their normal
diabetes medication as appropriate, based on their reduced blood sugar
levels. Patients closely monitored their blood sugar by glucometer,
fingerstick strips or urine, daily during the 30-day trial. A physician team
carefully evaluated patients by lab values, physical exams and symptoms for
any potential problems. Participants were monitored once per week, at which
time a serum blood glucose, hemoglobin A1C, chemistry panel, CBC and
urinalysis were obtained. A follow-up visit 1 month after the conclusion of
the active phase of the study occurred.
The results of the study are set forth in the table below.
Out of nine patients taking insulin, eight were able to reduce insulin
usage, five by more than 50%. Out of eleven patients taking oral
hypoglycemics, nine were able to reduce medication usage by more than 50%.
The average fasting blood sugar for the patient group was reduced by more
Claim 1 of 7 Claims
1. A composition for reducing blood sugar in humans in need thereof,
comprising effective amounts of:
alpha lipoic acid;
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