Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2002-01-31
2004-08-24
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S401000, C424S451000, C424S464000
Reexamination Certificate
active
06780440
ABSTRACT:
DESCRIPTION
FIELD OF THE INVENTION
The invention relates to herbal compositions for weight loss management and treating diabetes in humans. The invention further relates to a method comprising the composition for reducing weight and treating diabetes in humans. The invention further relates to a method for extraction and standardization of a
Ferula hermonis
extract useful for human health.
BACKGROUND OF THE INVENTION
Obesity and overweight are associated with diabetes, hypertension and other diseases that cause morbidity, mortality and high health-care expenditure.
Obesity is the number one nutritional problem in the U.S. An estimated one third of Americans are overweight, with an additional 25 percent being classified as obese. Being overweight significantly increases a person's risk of developing diabetes, heart disease, stroke, and other diseases. Diabetes is a chronic disease that affects 16 million people in the U.S., and more than 125 million people worldwide. Diabetes is the fourth-leading cause of death by disease in the United States. About two-thirds of the nearly 16 million people with type II diabetes in the U.S. are overweight, according to the American Diabetes Association. This form of the disease occurs when the body does not properly respond to insulin. The body uses insulin, a hormone, to help regulate the blood level of glucose, or blood sugar.
In people with diabetes, the pancreas produces little or no insulin, the hormone responsible for facilitating uptake of glucose by cells to give energy as ATP, resulting in a high level of glucose in the blood, causing excessive urination and constant thirst and hunger.
There are two main types of diabetes mellitus, Type I and Type II. In Type I, the more severe form and accounts for 5 to 10 percent diabetes, the body does not produce any insulin, most often occurring in children and young adults. Without regular injections of insulin the sufferer lapses into a coma and dies. Individuals suffering from Type I diabetes are totally insulin dependent.
Type II diabetes, the most prevalent type of diabetes, is usually of gradual onset and occurs mainly in people over 40. Type II diabetes is a metabolic disorder resulting from the body's inability to make enough, or properly use, insulin to meet the body's needs, especially when the person is overweight. It is the most common form of the disease. Type II diabetes accounts for 90 to 95 percent of diabetes. Type II diabetes is nearing epidemic proportions due to a greater prevalence of obesity and sedentary lifestyles. Initially, the combination of dietary measures, weight reduction and oral medication can keep the condition under control for a period of time, but most people with Type II diabetes ultimately require insulin injections.
Medical complications arise from diabetes include athreosclerosis, hyperlipidemia, retinal damage, neurological damage, and blindness.
Diabetes may be controlled with insulin and in some cases through careful diet. There is a need for a safe and effective treatment for diabetes with minimal side effects and without the invasive procedure, such as insulin injection.
Weight loss is considered the cornerstone of treatment in people with Type II diabetes because it allows the body to better use insulin and thus lowers blood sugar. Out-of-control levels of blood sugar are responsible for many of the devastating side effects of diabetes.
Researchers at Harvard found that more than 90 percent of the 3,300 women who developed diabetes over a 16-year study period were overweight, inactive, and smokers. These data come from the ongoing Nurse's Health Study, which began in 1976. The researchers followed 85,000 female nurses who were free of heart disease, diabetes, and cancer at the beginning of the study. The low risk group had a body-mass index (calculated as weight in kilograms divided by the square of height in meters) of less than 25 and a diet high in fibers and polyunsaturated fat and low in trans fat and glycemic load (which reflects the effect of diet on the blood glucose level). Being overweight or obese was the most important diabetes risk predictor, followed by lack of exercise. The study suggests that most of diabetes can be prevented through diet and exercise. Maintaining a healthy weight is the most important way to reduce risk of Type II diabetes. Effective methods for weight reduction are constantly being sought. No one approach, whether dietetic management, or commercial weight loss program, can alone solve the obesity problem. Most weight reduction treatment regimens involve caloric restriction, which is based on the principle that if intake of food is less than energy expenditure, stored calories, will be consumed, mainly in the form of fat. However, once the diet regimen is stopped, weight is quickly regained.
Other treatment regimens are based on the principle of increasing metabolism. By increasing metabolism, calories are burned thereby decreasing body weight. Herbs and their extracts have also been used to control weight, for example U.S. Pat. No. 5,945,107 describes compositions and methods containing herbal plant extracts for weight reduction. Guarana which contains caffeine, as an active ingredient, has been incorporated into weight loss products (Hurel, J. -P., 1993, FR 2 712 191-A1). Primez (Belgium Patent 100593A7) describes a phyto-active mixture referred to as Lycopodium, which contains Guarana and other plant extracts including
Scillia maritime, Ephedra vulgaris
, and
Betula alba
to produce weight loss.
Dietary supplements containing a thermogenic substance, an adrenal support substance, thyrogenic substance and a blood sugar regulation substance are disclosed in U.S. Pat. No. 6,277,396. The thermogenic substance, to increase metabolism and accelerate calorie expenditures, is selected from a group consisting of caffeine, catechins, MaHuang, ephedrine, synephrine, norephedrine, psuedoephedrine, and White Willow. The adrenal support substance, to maintain and/or improve adrenal functions and to reduce stress, is selected from a group consisting of Cordyceps, Ashwagandha, Astragalus, ginseng, Schisandra, Siberian ginseng, licorice, Asian ginseng, Codonopsis, adrenal glandular extract, embryo extract. The thyrogenic substance, to support and/or improve thyroid functions, is selected from a group consisting of Guggul (guggelsterones), thyroid glandular extract, and tyrosine.
The blood sugar regulation substance, to regulate or manipulate blood sugar levels and/or glucose metabolism and to help stabilize normal sugar levels and increase the body's ability to lose stored body fat, is selected from a group consisting of Bitter Melon (
Momordica charantia
), vanadium, allano lactone, Fenugreek (
Trigonella foenumgraecum
), Garcinia (
Garcinia cambogia
), gymnema (
Gymnema sylvestra
), marshmallow (
Althaea officinalis
), chromium, chromium GTF, chromium picolinate, chromium polynicotinate, alpha lipoic acid, inula racemusa, zinc, magnesium, cyclo-hispor,
Agaricus campestris
(mushroom),
Medicago sativa
(Lucema), pinitol (
Bougainvillea spectabilis
).
U.S. Pat. No. 6,042,834 discloses an herbal composition comprising
Trigonella foenum
-
graecum, Nigella sativa, Origanum vulgare, Rosemarinus officinalis, Lupinus termis, Lawsonia inermis
and
Foeniculum vulgare
for the treatment of diabetes.
Several other herbal compositions have also been developed for reducing weight and treating diabetes in humans; for example U.S. Pat. No. 5,055,460 discloses a composition for reducing weight comprising ephedrine, acetyl salicylic acid and caffeine.
However, none of the compositions and methods for weight reduction or treatment of diabetes in humans disclose a composition and a method consisting
Ferula hermonis
or an extract thereof, or
Ferula hermonis
and one or more of selected herbs or extracts thereof, and mixture thereof, which are disclosed in the present invention.
SUMMARY OF THE INVENTION
The present invention relates to compositions for weight loss management and reducing serum glucose levels in h
Page Thurman K.
Tran S.
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