Weight loss abstract
Herbal compositions and methods suitable for weight loss management
and for treating diabetes are disclosed. The compositions comprise
Ferula hermonis or an extract thereof, or Ferula hermonis with selected
herbs, extracts thereof, and mixture thereof. The methods of reducing
weight, and treating diabetes in patients involve oral administration
of the compositions. The invention further relates to a method of
extracting and standardizing Ferula hermonis extracts and tincture
useful for human health.
Weight loss claims
What is claimed is:
1. An oral herbal composition for the treatment of diabetes and
weight loss management in patients consisting of 0.01 to 4.0 grams
of Ferula hermonis, wherein Ferula hermonis consists of the sesquiterpenes:
8,9-epoxy jaeschkeanadiol benzoate (epoxy ferutinol benzoate, (3)):
jaeschkeandiol vanillate (ferutinol vanillate, (4)); jaeschkeanadiol
p-hydroxybenzoate (ferutinin, (1)); jaeschkeanadiol benzoate (Teferdin,
(2)); jaeschkeanadiol (ferutinol, (5)) 8,9-epoxy jaeschjeanadiol
(12); 14-(14'-hydroxybenzoyloxy) dauc-4,8-diene (6); 14-(14'-hydroxy-3'-methoxy-benzoyloxy)
dauc-4,8-diene (7); 14-benzoyloxy-dauc-4,8-diene (10); 8,9-epoxy
jaeschkeanadiol p-hydroxybenzoate (Tenuferidin (11)); and jaeschkeanadiol
p-methoxybenzoate (8); 8,9-epoxy jaeschkeanadiol m,p-dihydroxybenzoate
(9), with one or more of selected herbs, and mixture thereof.
2. The composition according to claim 1, wherein the selected herb
in an effective amount is selected from the group consisting of,
but not limited to, Gaurana, Garcinia cambogia, Ginkgo, Ginseng,
Senna, Juniper, Citrus aurantium, Cichorium, Ephedra, White Willow
bark, Oolong tea, Chromium, Carnitine, Green tea extract, Ginger,
Licorice, Cayenne, Gymnema sylvestre, Bitter melon, Neem, Nigella
sativa, Foeniculum vulgare (Fennel), Salvia officinalis (Sage),
Rosemarinus officinalis (Rosemary), Fenugreek, Majoram, Lupinus
termis (Egyptian lupin), Airelle, Eucalyptus, Rheum Rhubarb, Thyme,
Alpha lipoic acid, Alpinia officinarum, Colchicum, Hawthorn, Cupressus
sempervirens, Phaselous vulgaris, Tamarindus indica, Aloe.
3. The composition of claim 1, wherein Ferula hermonis extract
is extracted by a process consists of: (a) extracting Ferula hermonis
roots with a suitable solvent, including water, an alkyl alcohol,
or a non-polar organic solvent with heating for 5 hours and stirring,
and then further stirred at room temperature for 24 hours, (b) filtering
the resulting extract through a cloth or a filter papa to yield
a tincture or a filtrate, (c) concentrating the filtrate to a small
volume, which on standing at room temperature yield a Ferula hermonis
extract, or (d) evaporating the solvent under vacuum at 40.degree.
C. to yield Ferula hermonis extract.
4. A method of reducing weight end treating diabetes in patients
consists of administration of the composition of claim 1.
5. The method of claim 4, wherein Ferula hermonis is made by the
process of claim 3.
Weight loss description
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 humans by ingesting Ferula
hermonis or an extract thereof, or Ferula hermonis with one or more
of selected herbs, or extracts thereof. In one embodiment, Ferula
hermonis is ingested in an amount of about 2 grams to about 4 grams
per day total, preferably in at least 2 doses.
In another aspect, the present invention relates to a method for
managing weight loss and hyperglycemia in humans, by ingesting Ferula
hermonis or extract thereof, or Ferula hermonis in combination with
one or more of selected herbs. The present invention further relates
to a method of extraction and standardization of a Ferula hermonis
extract useful for human health.
Additional embodiments will be apparent to those skilled in the
art with references to the following detailed description.
Ingestion of 3.5 grams of Ferula hermonis with meal two times per
day for one month resulted in lowering blood sugar, and in weight
reduction of 4 to 6 pounds.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to a composition comprising the herb
Ferula hermonis or its extract, or Ferula hermonis with one or more
of selected herbs that produces weight loss and treats diabetes
in patients.
Another object of the present invention is to provide a method
of reducing weight and treating diabetes in patients, which comprises
administering to the patient a composition of Ferula hermonis or
its extract, or a combination of Ferula hermonis with one or more
of selected herbs.
The present invention further comprises at least one herb or an
extract thereof capable of promoting weight loss or treating diabetes.
The composition of the present invention thus provides a combination
of selected herbal extracts, which has been shown to be effective
in producing weight loss, and lowering blood sugar in diabetes.
Herbal plant extracts suitable for incorporation into a composition
of the present invention for achieving a weight loss include, but
is not limited to, herbs disclosed in U.S. Pat. Nos. 5,945,107 and
6,277,396. In addition to ginger, Citrus aurantium and Cayenne.
As will be obvious to those of skill in the art, other herbal extracts
having these active ingredients can also be selected for use in
a composition of the present invention. Herbal extracts for combination
into a composition of the present invention are obtained in accordance
with methods well known and routine to those of skill in the art.
The herbs of the present invention have been part of folk medicine
and have been used for different human ailments and when used as
directed no toxicity has been associated with any of them that are
reportable.
Ferula hermonis (known as Shirsh Zallouh) has recently received
much attention due to its commercial value as an aphrodisiac, and
as an herbal alternative to Viagra.TM. without the side effects.
Shirsh Zallouh is the Arabic for "hairy root", a perennial
of the parsley family.
Shirsh Zallouh has its root in Lebanon; and in northern Lebanon
it is called Hashishat al-Kattira, which means herb of abundance.
Shirsh Zallouh is a small shrub, with pale pink flowers. It grows
at more than 6000 feet on the high mountain areas of northern Lebanon,
and on the biblical Mount Hermon in Southern Lebanon, at the joint
borders of Syria and Israel.
Shirsh Zallouh roots are usually picked in the summer, after they
mature and before the snow-season. There are six different species
of the plant Ferula, one of them contained the poison that killed
the ancient Greek Philosopher Socrates. Ferula hermonis belongs
to the family of plants known as the Umbelliferae. This family contains
plants like the carrot, fennel, Chinese angelica and hemlock. Hemlock,
of course, is extremely poisonous and there are reports that naive
ferula hunters are endangering their lives by picking hemlock, which
is almost identical in appearance to Ferula.
Zallouh' sexual potency was discovered by goat herders who noticed
its strong sexual effects on their herds after eating this plant
during the mating season.
Middle East herbalists have used Shirsh Zallouh for centuries as
a folk remedy to treat frigidity in women, and erectile and sexual
dysfunction in men by increasing blood flow to sexual organs with
dazzling results, and have reported renewed vigor, potency and energy.
Shirsh Zallouh has been used by the elderly, in the Middle East
for centuries to reinvigorate their sex lives.
In humans, the aphrodisiac property and safety of Zallouh has been
demonstrated in clinical trials involving more than 7,000 men with
erectile dysfunction. The studies found that Zallouh improved sexual
function, increased libido and firmness of erections within few
days. Zallouh may work immediately for some, and may take few weeks
for others.
The efficacy and safety of Zallouh in the treatment of erectile
dysfunction was demonstrated in a number of clinical trials. These
trials revealed that 60 to 88 percent of men with erectile dysfunction
experienced improved erections and increased desire within a few
weeks after taking Zallouh root; less than 4 percent experienced
side effects such as headaches and flushing. The studies also found
that Zallouh may work almost immediately for some, and may take
several weeks for others.
Zallouh root also contains naturally occurring vitamins (A, B1,
B2, B6, C, D, and E) and minerals (iron, magnesium, selenium, and
zinc).
The traditional Lebanese way to take this herb is to slit the root
and wait for the resin to ooze out. This process is now replaced
by the more efficient extraction procedure. Lebanese pharmacists
cut up the root and make an extract by a hot extraction and distillation.
It is recommended that men take 50 drops (two and half ml) of an
alcohol (alcohol concentration of over ninety percent) extract of
Zallouh root at night and again first thing in the morning. This
regimen should be followed for at least four weeks. For women suffering
from menstrual/menopausal complaints, 50 drops three times daily,
after meals. The roots can also be soaked in wine or ground into
powder and then taken in capsules or mixed with tea. In Syria, the
powder is mixed with honey.
The suggested dose ranges from two to eight grams of Zallouh root
taken as a tea. Some studies also indicated that a significant number
of males experienced increased number of erections by taking Zallouh
one to three hours prior to the anticipated sexual encounter.
Because of the vasodilatation effects of Zallouh, people with cardiovascular
or neurological disorder should consult a heath care professional
before taking this supplement. The common side effects associated
with Zallouh are headaches, flushing, and gastrointestinal tract.
Profiling of Sesquiterpenes from Ferula Hermonis Using LC/MS
Liquid chromatography/mass spectroscopy (LC/MS) method was used
for the determination and profiling of sesquiterpenes in Ferula
hermonis extracts.
Ferula genus (Umbelliferae) constitutes about 150 species, and
these are widely distributed throughout the Mediterranean area to
central Asia. Medicinal properties of Ferula plants include antispasmodic,
carminative, digestive, expectorant, sedative, antihysteric, laxative,
aphrodisiac, antiseptic, and analgesic. The genus ferula species
are rich in the sesquiterpenes daucanes, humulanes, carotanes, himachalanes,
and guaianes.
Previous phytochemical investigations on Ferula hermonis revealed
the presence of .alpha.-bisabolol and the daucane sesquiterpenes:
8,9-epoxy jaeschkeanadiol benzoate (epoxy ferutinol benzoate, (3)),
jaeschkeanadiol vanillate (ferutinol vanillate, (4)), jaeschkeanadiol
p-hydroxybenzoate (ferutinin, (1)), jaeschkeanadiol benzoate (Teferdin,
(2)), jaeschkeanadiol (ferutinol, (5)), 8,9-epoxy jaeschjeanadiol
(12), 14-(14'-hydroxybenzoyloxy) dauc-4,8-diene(6),and 14-(14'-hydroxy-3'-methoxy-benzoyloxy)
dauc-4,8-diene (7).
Compounds (1) and (6) have been shown to exhibit antimicrobial
activity against Staphylococcus aures and Methicillin-resistant
s. aureus. Ferutinine (1) and Tenuferidine (11) have been shown
to have esterogenic activity, and may contribute to its aphrodisiac
activity.
In a recent study on HPLC analysis of Ferula hermonis, compounds
(1), (2), (3), and (4) were quantified as the marker sesquiterpenes
esters, with (1) and (2) as the major components. We used liquid
chromatography coupled with mass spectroscopy to standardize Ferula
hermonis products, and I discovered sesquiterpenes (8), (9), (10)
and (11) not previously reported in Ferula hermonis.
Development of accurate quantitative profile of analysis for specific
marker compounds in herbal manufacturing is critical for determining
the quality and consistency of raw materials and finished products.
To identify the individual peaks in the HPLC chromatogram of the
Ferula hermonis extract, we used LC-atmospheric pressure chemical
ionization in both the positive and negative mode MS analyses
In accordance with previous phytochemistry studies, the mass spectrum
of a methanol extract of Ferula hermonis we obtained showed peaks
in the positive ion mode at m/z=341 and m/z=371 corresponding to
compounds (6) and (7), respectively; and peaks in the negative mode
at m/z=357 and m/z=341 corresponding to compounds (1) and (2), respectively.
In addition to ions at m/z 325 (positive mode); and 373, and 389
(negative mode), which we assigned to compounds ((14-benzoyloxy)dauc-4,8-diene,
(10)); (8,9-epoxy jaeschkeanadiol p-hydroxybenzoate, Tenuferidin
(11)); and (8,9-epoxy jaeschkeanadiol m,p-dihoxybenzoate, (9)),
respectively; and a peak at m/z=373 (positive mode) corresponding
to jaeschkeandiol p-methoxybenzoate (8). The Teferdin (4) was also
seen in the mass spectrum of the alcoholic tincture at 387 (negative
mode), Table (1).
The 14-benzoyloxy-daucane esters (6) and (7) were co-eluted at
9.5 minutes, with (M+1).sup.+ at m/z 341 and 371, respectively;
followed by (10) with a retention time (rt) 11.9 minutes and (M+1).sup.+
at m/z 325. All the peaks at m/z 341, 371, 325 (in the positive
mode) showed m/z 203 corresponding to M-ester group (122 for benzoate,
168 for vanillate, 138 for p-hydroxy benzoate). The epoxy jaeschkeanadiol
derivatives were eluted in the following order: (9) (rt=6.4 min),
(11) (rt=6.8 min); and the jaeschkeanadiol derivative (1) at rt=9.4
min.
Compounds (2) and (4) were also observed in the alcoholic tincture
of Ferula hermonis.
Compounds (8), (9), (10), and (11) were not reported in the previous
phytochemistry studies on Ferula hermonis.
TABLE 1 Pertinent parameters of the LC/MS analyses of Ferula hermonis
extracts Compound rt(min) (M - 1).sup.+ (M + 1).sup.+ 2 1.52 341
4 1.52 387 9 6.3 389 8 6.4 371 11 6.8 373 1.sup.c 9.4 357 6.sup.a
9.5 341 7.sup.b 9.5 371 10 325 8 373 .sup.a 14-(4'-hydroxybenzoyloxy)dauc-4,8-diene
.sup.b 14-(4'-hydroxy-3'-methoxybenzoyloxy)dauc-4,8-diene .sup.c
jaeschkeanadiol-p-hydroxybenzoate
TABLE 2 Compound Formula Calculated Found 9 C.sub.22 H.sub.30 O.sub.6
389.1964 389.1961 1 C.sub.22 H.sub.30 O.sub.4 357.2066 357.2075
6 C.sub.22 H.sub.28 O.sub.3 341.2116 341.2118 7 C.sub.23 H.sub.30
O.sub.4 371.2222 371.2211 10 C.sub.22 H.sub.28 O.sub.2 325.2167
325.2177 2 C.sub.22 H.sub.30 O.sub.3 373.2379 373.2368 8 C.sub.23
H.sub.32 O.sub.4 389.1964 389.1961
Numerous modifications and variations of the present invention
are possible in light of the above teachings. It is therefore to
be understood that within the scope of the attendant claims attached
hereto, this invention may be practiced otherwise than as specifically
disclosed herein.
As will be apparent to persons skilled in the art, modifications
and adaptations to the above-described invention can be made without
departing from the spirit and scope of the invention.
From the foregoing description, it will be apparent to one of ordinary
skill in the art that certain modifications and changes can be made
without departing from the spirit and scope of the invention.
REFERENCES
Hu F B, Manson J E et al. Diet, Life style, and the risk of Type
2 diabetes mellitus in women. The New England Journal of Medicine
2001; 345:790-797
Al-Yahia M A, Muhammad I, Mirza H H, El-Feraly F S. Antibacterial
constituents from the rhizomes of Ferula communis. Phytotherapy
Research 1998; 12:335-339
Khleifat K, Homady M H, Tarawneh K A, Shakhanbeh J. Effect of ferula
hormonis extract on social aggression, fertility and some physiological
parameters in prepubertal male mice. Endocr J 2001; 48:473
El-Thaher T S, Matalka K Z, Taha H A, Badwan A A. Ferula harmonis
`Zaalouh` and enhancing erectile function in rat-efficacy and toxicity
study. Int J Impot Res 2001; 13:247
Ahmed A A. Daucanes and other constituents from Ferula sinaica.
Phytochemistry 1991; 30:1207-1210
Abramov A Y, Zamaraeva M V, Hagelgans A I, Azimov R R, Krasilnikov
O V. Influence of plant terpenoids on the permeability of mitochondria
and lipid bilayers. Biochimica et Biophysica Acta 2001; 1512:98
Galal A. Sesquiterpenes from Ferula hermonis Boiss. Pharmazie 2000;
55:961-962
Galal A M, Abourashed E A, Ross S A, ElSohly M A, Al-Said, M S,
El-Feraly F S. Daucane sesquiterpenes from Ferula hermonis. J Nat
Prod 2001; 64:399-400
Abourashed E A, Galal A M, El-Feraly, Khan I A. Separation and
quantification of the major Daucane esters of Ferula hermonis by
HPLC. Planta Med 2001; 67:681 |