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Weight Loss Patent Abstract
A diet supplement is provided in two parts. One part is provided
in a daytime formulation comprising at least the Calcium and Potassium
double salt of Garcinia Cambogia Extract, and Green Tea Leaf Extract.
The second part is provided in a night time formulation comprising
at least the Calcium and Potassium double salt of Garcinia Cambogia
Extract and Melatonin. The prevent invention provides a daily diet
cycle for enhancing fast weight loss, improving day-time energy,
promoting nighttime relaxation and sleep, controlling appetite and
increasing metabolism.
Weight Loss Patent Claims
1. A diet supplement comprising at least the Calcium and Potassium
double salt of Garcinia Cambogia Extract providing about 60% Hydroxycitric
Acid, and one of Green Tea Leaf Extract and Melatonin.
2. The diet supplement of claim 1, further comprising Gymnema Sylvestre
Extract and Chromium Polynicotinate.
3. The diet supplement of claim 2, further comprising Griffonia
Simplicifolia Extract.
4. The diet supplement of claim 3, further comprising Enriched
Soy Phospholipids.
5. The diet supplement of claim 4, further comprising Anhydrous
Caffeine.
6. The diet supplement of claim 5, further comprising Passionflower.
7. The diet supplement of claim 6, further comprising Chamomile.
8. The diet supplement of claim 7, further comprising Valerian
Root Extract.
9. A diet supplement comprising: about 1.555 g of the Calcium and
Potassium double salt of Garcinia Cambogia Extract providing about
60% Hydroxycitric Acid per serving; about 0.30444 g of Green Tea
Leaf Extract per serving; about 0.133 g of Gymnema Sylvestre Extract
per serving; about 0.02 g of Griffonia Simplicifolia Extract per
serving; about 0.001 g of Enriched Soy Phospholipids per serving;
about 0.075 g of Anhydrous Caffeine per serving; and about 0.00133
g of Chromium Polynicotinate.
10. A diet supplement comprising: about 1.182 g of the Calcium
and Potassium double salt of Garcinia Cambogia Extract providing
about 60% Hydroxycitric Acid per serving; about 0.15 g of Passionflower
per serving; about 0.133 g of Gymnema Sylvestre Extract per serving;
about 0.003 g of Melatonin per serving; about 0.001 g of Chamomile
Extract per serving; about 0.0001 g of Valerian Root Extract per
serving; and about 0.00133 g Chromium Polynicotinate per serving.
11. A method for at least one of promoting fast weight loss, controlling
appetite, improving daytime energy, promoting fast weight loss and
increasing metabolism, comprising the step of administering to a
human or animal the diet supplement of claim 1, wherein the diet
supplement includes Green Tea Leaf Extract.
12. A method for increasing nighttime relaxation comprising the
step of administering to a human or animal the diet supplement of
claim 1, wherein the diet supplement includes Melatonin.
13. The method of claim 11, wherein the diet supplement is administered
twice daily, once before breakfast and once before lunch.
14. The method of claim 12, wherein the diet supplement is administered
once daily before dinner.
15. A method comprising the steps of: administering to a human
or animal twice daily, once before breakfast and once before lunch,
the diet supplement of claim 1, wherein the diet supplement includes
Green Tea Leaf Extract; and administering once daily, before dinner,
the diet supplement of claim 1, wherein the diet supplement includes
Melatonin.
16. A kit comprising: a first composition comprising at least the
Calcium and Potassium double salt of Garcinia Cambogia Extract providing
about 60% Hydroxycitric Acid, and Green Tea Leaf Extract; and and
a second composition comprising at least the Calcium and Potassium
double salt of Garcinia Cambogia Extract providing about 60% Hydroxycitric
Acid, and Melatonin.
17. A method comprising the step of administering the kit of claim
16 as a daily cycle of a diet supplement regime.
18. A method for promoting accelerated weight loss in new mothers
comprising the step of administering the kit of claim 16.
19. A method for manufacturing a daytime formulation of a diet
supplement comprising the step of: forming a caplet comprising at
least the Calcium Hydroxycitrate and Potassium Hydroxycitrate double
salts of Garcinia Cambogia Extract providing at least 60% Hydroxycitric
Acid, and Green Tea Extract; mixing demineralized water, propylene
glycol, titanium dioxide, riboflavin, hydroxypropyl methylcellulose,
carboxymethylcellulose, maltodextrin, dextrose monohydrate, colorings
and soy lecithin; and using the mixture to sweet-coat the caplets.
20. A method for manufacturing a nighttime formulation of a diet
supplement comprising the step of: forming a caplet comprising at
least the Calcium Hydroxycitrate and Potassium Hydroxycitrate double
salts of Garcinia Cambogia Extract providing at least 60% Hydroxycitric
Acid, and Melatonin; mixing demineralized water, propylene glycol,
titanium dioxide, riboflavin, hydroxypropyl methylcellulose, carboxymethylcellulose,
maltodextrin, dextrose monohydrate, polysorbate 80, colorings and
soy lecithin; and using the mixture to sweet-coat the caplets.
Weight Loss Patent Description
RELATED APPLICATIONS
[0001] The application is related to and claims benefit of priority
to Applicant's co-pending U.S. Provisional Patent Application Ser.
No. 60/691,661 entitled "Diet Supplement for Causing Rapid
Weight Loss, Improving Day Time Energy, Promoting Nighttime Relaxation
and Sleep, Controlling Appetite and/or Increasing Metabolism,"
filed Jun. 17, 2005, the disclosure of which is hereby fully incorporated
by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to a diet supplement, that
includes the calcium and potassium double salt of Garcinia Cambogia
and one of Green Tea Leaf Extract or Melatonin. In addition, the
present invention relates to a method for causing fast weight loss,
improving daytime energy, promoting nighttime relaxation and sleep,
controlling appetite and/or increasing metabolism comprising the
step of consuming the diet supplement. In addition, the present
invention relates to a method of manufacturing the diet supplement.
SUMMARY OF THE INVENTION
[0003] The present invention provides for a diet supplement for
causing fast weight loss, improving daytime energy, promoting nighttime
relaxation and sleep, controlling appetite and/or increasing metabolism.
The diet supplement is particularly well suited for mothers, e.g.,
new mothers after childbirth, having a heightened need for fast
weight loss, supplemental daytime energy, improved nighttime relaxation
and sleep, more controlled appetite and/or an increased metabolism.
Advantageously, the diet supplement provides a 24-hour benefit by
way of two compositions. For example, the diet supplement may provide
two or more different compositions, together comprising one daily
diet supplement cycle. A first composition comprising at least the
Calcium and Potassium double salt of Garcinia Cambogia Extract supplying
60% Hydroxycitric Acid, and Green Tea Leaf Extract may be a daytime
formula and may provide benefits most needed by an individual during
the day. A second composition comprising at least the Calcium and
Potassium double salt of Garcinia Cambogia Extract supplying 60%
Hydroxycitric Acid, and Melatonin may be provided as a nighttime
formula and may provide benefits most needed by an individual during
the night.
[0004] The present invention also provides, by the consumption
of the diet supplement, a method for causing fast weight loss, improving
daytime energy, promoting nighttime relaxation and sleep, controlling
appetite and/or increasing metabolism.
[0005] In addition, the present invention relates to a method of
manufacturing a diet supplement for causing fast weight loss, improving
daytime energy, promoting nighttime relaxation and sleep, controlling
appetite and/or increasing metabolism. In one embodiment, there
is provided a method of manufacturing a first composition of a diet
supplement, the first composition comprising at least the Calcium
and Potassium double salt of Garcinia Cambogia Extract supplying
60% Hydroxycitric Acid, and Green Tea Leaf Extract. In a second
embodiment, there is provided a method of manufacturing a second
composition of a diet supplement, the second composition comprising
at least the Calcium and Potassium double salt of Garcinia Cambogia
Extract supplying 60% Hydroxycitric Acid, and Melatonin.
DETAILED DESCRIPTION OF THE INVENTION
[0006] The present invention, according to various embodiments
thereof, is directed to a diet supplement for inducing fast weight
loss, improving daytime energy, promoting nighttime relaxation and
sleep, controlling appetite and/or increasing metabolism.
[0007] The diet supplement is particularly well suited for mothers,
e.g., new mothers after childbirth, having a heightened need for
fast weight loss, supplemental daytime energy, improved nighttime
relaxation and sleep, more-controlled appetite and/or an increased
metabolism. Advantageously, the diet supplement provides a 24-hour
benefit by way of two compositions. For example, the diet supplement
may provide two or more different compositions which together comprise
one daily diet supplement cycle. A first composition may be a daytime
formula and may provide benefits most needed by an individual during
the day. A second composition may be a nighttime formula and may
provide benefits most needed by an individual during the night.
More specifically, the diet supplement may include a first, e.g.,
daytime, composition to be consumed early in the daytime such as
prior to breakfast and/or lunch, and a second, e.g., nighttime,
composition to be consumed prior to the nighttime such as prior
to dinner.
[0008] Calcium and Potassium Double Salt of Garcinia Cambogia (Supplying
60% HCA)
[0009] Hydroxycitric acid (HCA) is extracted from the fruit of
the Garcinia Cambogia plant. It is used to control weight by virtue
of its ability to inhibit fat production and suppress appetite.
[0010] U.S. Pat. No. 6,875,891, entitled "Process for Preparing
Highly Water Soluble Double Salts of Hydroxycitric Acid Particularly
Alkali and Alkaline Earth Metal Double Salts," the disclosure
of which is hereby fully incorporated by reference, describes a
method for producing highly water-soluble Calcium and Potassium
Hydroxycitric Acid salts which are odorless and essentially tasteless.
The process involves the steps of precipitating sparingly soluble
alkaline earth metal salts of Hydroxycitric acid from an aqueous
extract of plants belonging to the Garcinia species, dissolving
said alkaline earth metal salts in aqueous alkali and adjusting
the pH of said alkaline solution by adding an extract of purified
Garcinia fruit extract. From this process, the Calcium salt of Hydroxycitric
Acid can be precipitated. Additionally, said Calcium salt can be
treated with Potassium Hydroxide to form the Potassium and Calcium
double salt of Hydroxycitric Acid which can further be purified
by treatment with activated charcoal, filtered and spray dried.
[0011] HCA has been shown to inhibit fatty acid synthesis and repress
appetite in rats (Watson, J. A., M. Fang, and J. M. Lowenstein,
Tricarballylate and hydroxycitrate: substrate and inhibitor of ATP:
citrate oxaloacetate lyase. Arch Biochem Biophys, 1969. 135(1):
p. 209-17., Louter-van de Haar, J., et al., Comparison of the effects
of three different (-)-hydroxycitric acid preparations on food intake
in rats. Nutr Metab (Lond), 2005. 2: p. 23.). It is additionally
known to be a competitive inhibitor of ATP:citrate lyase; an enzyme
necessary for the conversion of carbohydrates into fat. By inhibiting
this enzyme, HCA blocks the body's ability to produce fat from carbohydrate
sources. Garcinia Cambogia extract has also been shown to improve
glucose metabolism in mice (Hayamizu, K., et al., Effect of Garcinia
cambogia extract on serum leptin and insulin in mice. Fitoterapia,
2003. 74(3): p. 267-73.).
[0012] Several human clinical trials have demonstrated safety and
beneficial effects of HCA in terms of weight management. HCA clinical
studies have shown that its administration is able to produce a
reduction caloric intake (Westerterp-Plantenga, M. S. and E. M.
Kovacs, The effect of (-)-hydroxycitrate on energy intake and satiety
in overweight humans. Int J Obes Relat Metab Disord, 2002. 26(6):
p. 870-2.) while further increasing fat oxidation during exercise
in untrained men and women (Lim, K., et al., (-)-Hydroxycitric acid
ingestion increases fat utilization during exercise in untrained
women. J Nutr Sci Vitaminol (Tokyo), 2003. 49(3): p. 163-7., Tomita,
K., et al., (-)-hydroxycitrate ingestion increases fat oxidation
during moderate intensity exercise in untrained men. Biosci Biotechnol
Biochem, 2003. 67(9): p. 1999-2001.). A randomized controlled trial
which combined data from two earlier trials demonstrated that daily
chromium supplementation with moderate exercise over a period of
8 weeks resulted in increased weight loss as compared to a placebo
group and an improved blood cholesterol profile (Preuss, H. G.,
et al., Efficacy of a novel calcium/potassium salt of (-)-hydroxycitric
acid in weight control. Int J Clin Pharmacol Res, 2005. 25(3): p.
133-44.). Additionally, levels of serotonin, a neurotransmitter
which when low provides a hunger signal particularly associated
with carbohydrate cravings, were significantly increased by HCA.
This could result in a reduction of carbohydrate cravings.
[0013] In an embodiment of the present invention, which is set
forth in greater detail in Example 1 below, the first, e.g., daytime,
composition of the diet supplement may include the Calcium and Potassium
double salt of Garcinia Cambogia Extract supplying 60% Hydroxycitric
Acid. A serving of the first, e.g., daytime, composition of the
diet supplement comprises from at least about 1 mg to about 10 g
of the Calcium and Potassium double salt of Garcinia Cambogia Extract
supplying 60% Hydroxycitric Acid. The preferred dosage of a serving
of the first, e.g., daytime, composition of the diet supplement
comprises about 1.555 g of the Calcium and Potassium double salt
of Garcinia Cambogia Extract supplying 60% Hydroxycitric Acid.
[0014] In an embodiment of the present invention, which is set
forth in greater detail in Example 2 below, the second, e.g., nighttime,
composition of the diet supplement may include the Calcium and Potassium
double salt of Garcinia Cambogia Extract supplying 60% Hydroxycitric
Acid. A serving of the second, e.g., daytime, composition of the
diet supplement may include from about 10 g of the Calcium and Potassium
double salt of Garcinia Cambogia Extract supplying 60% Hydroxycitric
Acid. In a preferred dosage, a serving of the second, e.g., nighttime,
composition of the diet supplement comprises about 1.555 g of the
Calcium and Potassium double salt of Garcinia Cambogia Extract supplying
60% Hydroxycitric Acid.
[0015] Green Tea (Catechins, ECGC, Norepinephrine Increase)
[0016] The active compounds of Green Tea are a family of polyphenols
(Catechins) wherein tannins are the largest of the group. The most
active specific compound is epigallocatechin gallate (ECGC) which
makes up 10-50% of the total Catechins. Green tea also contains
caffeine, although typically significantly less than black tea.
[0017] Green Tea mainly acts in a beneficial way through the polyphenol's
antioxidant activities as evidenced by several laboratory studies.
One clinical study has shown that ingestion of green tea extract
results in a rapid increase in plasma antioxidant activity (Benzie,
I. F., et al., Consumption of green tea causes rapid increase in
plasma antioxidant power in humans. Nutr Cancer, 1999. 34(1): p.
83-7.). Moreover, Green Tea has also been shown to be effective
in aiding weight loss (Chantre, P. and D. Lairon, Recent findings
of green tea extract AR25 (Exolise) and its activity for the treatment
of obesity. Phytomedicine, 2002. 9(1): p. 3-8.). This effect may
be due to two activities. Firstly, Green tea both reduces fat digestion
and secondly, it increases energy expenditure (Berube-Parent, S.,
et al., Effects of encapsulated green tea and Guarana extracts containing
a mixture of epigallocatechin-3-gallate and caffeine on 24 h energy
expenditure and fat oxidation in men. Br J Nutr, 2005. 94(3): p.
432-6.). The increase in energy expenditure may result from fat
stores via the oxidation of fat (thermogenesis) (Choo, J. J., Green
tea reduces body fat accretion caused by high-fat diet in rats through
beta-adrenoceptor activation of thermogenesis in brown adipose tissue.
J Nutr Biochem, 2003. 14(11): p. 671-6, Dulloo, A. G., et al., Efficacy
of a green tea extract rich in catechin polyphenols and caffeine
in increasing 24-h energy expenditure and fat oxidation in humans.
Am J Clin Nutr, 1999. 70(6): p. 1040-5.). The thermogenic activity
of Green Tea may be greatly enhanced by synergistic cooperation
with caffeine (Dulloo, A. G., et al., Green tea and thermogenesis:
interactions between catechin-polyphenols, caffeine and sympathetic
activity. Int J Obes Relat Metab Disord, 2000. 24(2): p. 252-8.).
[0018] The mechanism of action of Green Tea may be, at least partially,
due to an increase in norepinephrine. Catechins are known to inhibit
catechol-O-methyl-transferase (COMT), an enzyme that degrades norepinephrine
(Borchardt, R. T. and J. A. Huber, Catechol O-methyltransferase.
5. Structure-activity relationships for inhibition by flavonoids.
J Med Chem, 1975. 18(1): p. 120-2.). In turn, norepinephrine inhibits
degradation of intracellular cyclic AMP (cAMP), an important signaling
molecule involved in many metabolic processes including thermogenesis.
[0019] The first, e.g., daytime, composition of the diet supplement
includes Green Tea Dry Leaf Extract (camellia sinensis). A serving
of the first, e.g., daytime, composition of the diet supplement
may include about 1.0 mg to about 10 g of Green Tea Dry Leaf Extract
(camellia sinensis). The preferred dosage of the first, e.g., daytime,
composition of the diet supplement includes about 304.44 mg of Green
Tea Dry Leaf Extract (camellia sinensis).
[0020] Anhydrous Caffeine
[0021] Caffeine is a naturally occurring xanthine alkaloid found
in some plants where it serves as a natural pesticide. In humans,
however, it may have numerous beneficial effects, the most common
of which uses caffeine as a supplement to the central nervous system.
In this capacity, it is used as a stimulant and performance enhancer.
A meta-analysis complied from forty double-blind studies support
the use of caffeine to increase physical endurance (Doherty, M.
and P. M. Smith, Effects of caffeine ingestion on exercise testing:
a meta-analysis. Int J Sport Nutr Exerc Metab, 2004. 14(6): p. 626-46.;
Graham, T. E., E. Hibbert, and P. Sathasivam, Metabolic and exercise
endurance effects of coffee and caffeine ingestion. J Appl Physiol,
1998. 85(3): p. 883-9.; Kovacs, E. M., J. Stegen, and F. Brouns,
Effect of caffeinated drinks on substrate metabolism, caffeine excretion,
and performance. J Appl Physiol, 1998. 85(2): p. 709-15.).
[0022] Caffeine is also widely used to control weight, which may
occur through multiple mechanisms. Significant weight loss related
to caffeine supplementation has been observed in obese women (Yoshida,
T., et al., Relationship between basal metabolic rate, thermogenic
response to caffeine, and body weight loss following combined low
calorie and exercise treatment in obese women. Int J Obes Relat
Metab Disord, 1994. 18(5): p. 345-50.) which may be, at least in
part, due to increased lipolysis as fat is metabolized (Jung, R.
T., et al., Caffeine: its effect on catecholamines and metabolism
in lean and obese humans. Clin Sci (Lond), 1981. 60(5): p. 527-35.).
Caffeine has additionally been shown to increase the basal metabolic
rate (Roberts, A. T., et al., The effect of an herbal supplement
containing black tea and caffeine on metabolic parameters in humans.
Altern Med Rev, 2005. 10(4): p. 321-5.) wherein this also adds to
its weight-lowering effects.
[0023] Biochemically, caffeine as it is structurally similar, binds
to, but does not activate, adenosine receptors which are normally
activated by adenosine to induce sleep (Shi, D., et al., Chronic
caffeine alters the density of adenosine, adrenergic, cholinergic,
GABA, and serotonin receptors and calcium channels in mouse brain.
Cell Mol Neurobiol, 1993. 13(3): p. 247-61.).
[0024] The first, e.g., daytime, composition of the first, e.g.,
daytime, composition of the diet supplement may include anhydrous
caffeine. A serving of the first, e.g., daytime, composition of
the diet supplement may include from about 0.1 mg to about 1000
mg of anhydrous caffeine. In a preferred dosage, a serving of the
first, e.g., daytime, composition of the diet supplement comprises
about 75 mg of anhydrous caffeine.
[0025] Chromium Polynicotinate
[0026] Chromium is an essential trace mineral that is used to control
blood sugar levels by aiding insulin, which can help control or
reduce weight. Chromium, as it is poorly absorbed by the body, must
therefore be combined with a more efficiently absorbed compound
such as niacin (found in polynicotinate). Chromium likely exerts
its main function as a component of the glucose tolerance factor,
which is involved in insulin sensitivity.
[0027] Chromium has been shown clinically to additionally increase
lean mass (Bahadori, B., et al., [Effect of chromium yeast and chromium
picolinate on body composition of obese, non-diabetic patients during
and after a formula diet]. Acta Med Austriaca, 1997. 24(5): p. 185-7.)
and reduce body fat when combined with exercise (Grant, K. E., et
al., Chromium and exercise training: effect on obese women. Med
Sci Sports Exerc, 1997. 29(8): p. 992-8.). Furthermore, Chromium
has also been shown to increase HDL (`good`) cholesterol (Riales,
R. and M. J. Albrink, Effect of chromium chloride supplementation
on glucose tolerance and serum lipids including high-density lipoprotein
of adult men. Am J Clin Nutr, 1981. 34(12): p. 2670-8.).
[0028] Moreover, in an animal study designed to assess the effectiveness
of Chromium Polynicotinate supplementation on Metabolic Syndrome,
as defined by a cluster of risk factors including obesity, increased
abdominal fat, insulin resistance, hypertension and blood lipid
abnormalities, it was shown that compared to control groups Chromium
Polynicotinate was effective in lowering systolic blood pressure
(Talpur N., et al., Effects of Niacin-bound chromium, maitake mushroom
fraction SX and (-)-Hydroxycitric acid on the Metabolic Symdrome
in Aged Zucker Fatty Rats. Mol and Cell Biochem, 2003. 252 (1-2):
p. 369-77.). This study also observed less free radical damage in
the liver and kidney tissue as compared to controls, indicating
antioxidant properties. Additionally, this study suggests Chromium
supplementation may also benefit persons suffering from diabetes.
Further to the animal studies, a clinical study has shown that Niacin-bound
Chromium supplementation for 8 weeks is able to result in a significant
loss of body fat in overweight subjects as compared to a placebo
group, while sparing muscle from loss (Crawford V., et al., Supplementation
on body composition in overweight African-American women. Diabetes
and Obes Metab, 1999. 1(6): p. 331-37.).
[0029] In addition or alternatively, the first, e.g., daytime,
composition of the diet supplement may include Chromium Polynicotinate.
A serving of the first, e.g., daytime, composition of the diet supplement
may include from about 1 mcg to about 1000 mcg of Chromium Polynicotinate.
In a preferred dosage, a serving of the first, e.g., daytime, composition
of the diet supplement comprises about 133 mcg of Chromium Polynicotinate.
[0030] In addition or alternatively, the second, e.g., night-time,
composition of the diet supplement may include Chromium Polynicotinate.
A serving of the second, e.g., nighttime, composition of the diet
supplement may include from about 1 mcg to about 1000 mcg of Chromium
Polynicotinate. In a preferred dosage, a serving of the second,
e.g., nighttime, composition of the diet supplement comprises about
133 mcg of Chromium Polynicotinate.
[0031] Gymnema Sylvestre
[0032] Gymnema Sylvestre is a plant used in traditional Eastern
medicine to treat diabetes by virtue of its ability to inhibit glucose
absorption and suppress the taste of `sweetness`. In mice, a peptide
isolated from Gymnema Sylvestre has been shown to specifically inhibit
the mice's response to sucrose (Ninomiya, Y. and T. Imoto, Gurmarin
inhibition of sweet taste responses in mice. Am J Physiol, 1995.
268(4 Pt 2): p. R1019-25.). Moreover, Gymnema Sylvestre extracts
have also been shown to suppress cellular glucose uptake in various
animal models (Shimizu, K., et al., Suppression of glucose absorption
by some fractions extracted from Gymnema sylvestre leaves. J Vet
Med Sci, 1997. 59(4): p. 245-51.).
[0033] Gymnema Sylvestre extract in conjunction with insulin has
been shown to be more effective than insulin alone at controlling
blood glucose levels in patients with insulin-dependent diabetes
mellitus, Shanmugasundaram, E. R., et al., Use of Gymnema sylvestre
leaf extract in the control of blood glucose in insulin-dependent
diabetes mellitus. J Ethnopharmacol, 1990. 30(3): p. 281-94.). It
has further been shown to raise insulin levels in such patients
(Baskaran, K., et al., Antidiabetic effect of a leaf extract from
Gymnema sylvestre in non-insulin-dependent diabetes mellitus patients.
J Ethnopharmacol, 1990. 30(3): p. 295-300.) with insulin-dependent
diabetes mellitus. Gymnema Sylvestre extract has also been combined
with HCA to produce greater weight loss (Preuss, H. G., et al.,
Effects of a natural extract of (-)-hydroxycitric acid (HCA-SX)
and a combination of HCA-SX plus niacin-bound chromium and Gymnema
sylvestre extract on weight loss. Diabetes Obes Metab, 2004. 6(3):
p. 171-80.) in experimental settings.
[0034] The first, e.g., daytime, composition of the diet supplement
may include Gymnema Sylvestre Leaf Extract. A serving of the first,
e.g., daytime, composition of the diet supplement may include from
about 1 mg to about 2000 mg of Gymnema Sylvestre Leaf Extract. In
a preferred dosage, a serving of the first, e.g., daytime, composition
of the diet supplement comprises about 133 mg of Gymnema Sylvestre
Leaf Extract.
[0035] In addition or alternatively, the second, e.g., night-time,
composition of the diet supplement may include Gymnema Sylvestre
Leaf Extract. A serving of the second, e.g., nighttime, composition
of the diet supplement may include from about 1 mg to about 2000
mg of Gymnema Sylvestre Leaf Extract. In a preferred dosage, a serving
of the second, e.g., nighttime, composition of the diet supplement
comprises about 133 mg of Gymnema Sylvestre Leaf Extract.
[0036] Enriched Soy Phospholipids
[0037] Soy phospholipids (also known as phosphatides) are a major
class of lipids found in all living organisms. Phospholipids specific
to living organisms include phosphatidylcholine, phosphatidylethanolamine,
phosphatidylserine, and phosphatidylinositol. These phospholipids
have been shown to aid in the absorption of fat and may improve
cholesterol metabolism. A clinical trial demonstrated that administration
of a preparation containing soy phospholipids to subjects lowered
blood lipid-levels twice as much compared with a preparation devoid
phospholipids (Hoie, L. H., et al., A double-blind placebo-controlled
clinical trial compares the cholesterol-lowering effects of two
different soy protein preparations in hypercholesterolemic subjects.
Eur J Nutr, 2005. 44(2): p. 65-71.).
[0038] In addition, Phosphatidylserine has been demonstrated by
way of clinical trials to reduce stress and lower cortisol levels
(Monteleone, P., et al., Effects of phosphatidylserine on the neuroendocrine
response to physical stress in humans. Neuroendocrinology, 1990.
52(3): p. 243-8.; Monteleone, P., et al., Blunting by chronic phosphatidylserine
administration of the stress-induced activation of the hypothalamo-pituitary-adrenal
axis in healthy men. Eur J Clin Pharmacol, 1992. 42(4): p. 385-8.)
while positively affect mood (Benton, D., et al., The influence
of phosphatidylserine supplementation on mood and heart rate when
faced with an acute stressor. Nutr Neurosci, 2001. 4(3): p. 169-78.).
Cortisol is a hormone, which among its many effects, acts to breakdown
muscle. Phosphatidylserine also has been evidenced to increase exercise
capacity (Kingsley, M. I., et al., Effects of phosphatidylserine
on exercise capacity during cycling in active males. Med Sci Sports
Exerc, 2006. 38(1): p. 64-71.).
[0039] Phosphatidylcholine is a source of choline, which is required
for fat transport and normal brain functioning. It has been observed
that choline levels drop as a result of athletic activity such as
running (Conlay, L. A., L. A. Sabounjian, and R. J. Wurtman, Exercise
and neuromodulators: choline and acetylcholine in marathon runners.
Int J Sports Med, 1992. 13 Suppl 1: p. S141-2.). Therefore, choline
supplementation may aid in athletic performance. When used in combination
with carnitine and caffeine, choline can confer weight loss equal
to exercise in animal models (Hongu, N. and D. S. Sachan, Caffeine,
carnitine and choline supplementation of rats decreases body fat
and serum leptin concentration as does exercise. J Nutr, 2000. 130(2):
p. 152-7.). Clinical trials have demonstrated that choline combined
with carnitine aids weight loss (Hongu, N. and D. S. Sachan, Carnitine
and choline supplementation with exercise alter carnitine profiles,
biochemical markers of fat metabolism and serum leptin concentration
in healthy women. J Nutr, 2003.133(1): p. 84-9.).
[0040] The first, e.g., daytime, composition of the diet supplement
may include enriched Soy Phospholipids. A serving of the first,
e.g., daytime, composition of the diet supplement may include from
about 0.1 mg to about 100 mg of enriched Soy Phospholipids. In a
preferred dosage, a serving of the first, e.g., daytime, composition
of the diet supplement comprises about 1 mg of enriched Soy Phospholipids.
[0041] Griffonia Simplicifolia
[0042] Griffonia Simplicifolia seed is a source of 5-hydroxy-L-tryptophan
(5-HTP), which is a derivative of the amino acid tryptophan. In
the body, tryptophan can be converted to 5-HTP which can, in turn,
be converted into serotonin. Serotonin is a neurotransmitter which
when low signals hunger, particularly carbohydrate cravings (Schweiger,
U., et al., Macronutrient intake, plasma large neutral amino acids
and mood during weight-reducing diets. J Neural Transm, 1986. 67(1-2):
p. 77-86.).
[0043] Numerous clinical studies have found 5-HTP to be of benefit
in the treatment of such conditions as depression, fibromyalgia,
insomnia, headaches and obesity (reviewed in: Birdsall, T. C., 5-Hydroxytryptophan:
a clinically-effective serotonin precursor. Altern Med Rev, 1998.
3(4): p. 271-80.). Furthermore, at least three clinical trials have
demonstrated that 5-HTP can be used safely and effectively to aid
in weight loss (Cangiano, C., et al., Eating behavior and adherence
to dietary prescriptions in obese adult subjects treated with 5-hydroxytryptophan.
Am J Clin Nutr, 1992. 56(5): p. 863-7.; Cangiano, C., et al., Effects
of 5-hydroxytryptophan on eating behavior and adherence to dietary
prescriptions in obese adult subjects. Adv Exp Med Biol, 1991. 294:
p. 591-3.; Ceci, F., et al., The effects of oral 5-hydroxytryptophan
administration on feeding behavior in obese adult female subjects.
J Neural Transm, 1989. 76(2): p. 109-17.).
[0044] The first, e.g., daytime, composition of the diet supplement
may include Griffonia Simplicifolia Seed Extract. A serving of the
first, e.g., daytime, composition of the diet supplement may include
from about 1 mg to about 1000 mg of Griffonia Simplicifolia Seed
Extract. In a preferred dosage, a serving of the first, e.g., daytime,
composition of the diet supplement comprises about 20 mg of Griffonia
Simplicifolia Seed Extract.
[0045] Valerian Root
[0046] Valerian has traditionally been used to treat insomnia and
stress. There may be a specific active compound, or alternatively
a combination of compounds, contained in the Valerian Root Extract
that is responsible for the beneficial effects of Valerian in aiding
sleep. Compounds from Valerian Root are known to interact with the
GABA, melatonin, and/or adenosine receptor systems through binding
to certain melatonin and serotonin receptor subtypes (Abourashed,
E. A., U. Koetter, and A. Brattstrom, In vitro binding experiments
with a Valerian, hops and their fixed combination extract (Ze91019)
to selected central nervous system receptors. Phytomedicine, 2004.
11(7-8): p. 633-8.), particularly the 5-HT.sub.5A subtype (Dietz,
B. M., et al., Valerian extract and valerenic acid are partial agonists
of the 5-HT5a receptor in vitro. Brain Res Mol Brain Res, 2005.138(2):
p. 191-7.).
[0047] Clinical trials have demonstrated that Valerian Root is
safe and effective for treating stress and anxiety (Kohnen, R. and
W. D. Oswald, The effects of valerian, propranolol, and their combination
on activation, performance, and mood of healthy volunteers under
social stress conditions. Pharmacopsychiatry, 1988. 21(6): p. 447-8.)
as well as aiding sleep (Donath, F., et al., Critical evaluation
of the effect of valerian extract on sleep structure and sleep quality.
Pharmacopsychiatry, 2000. 33(2): p. 47-53.; Leathwood, P. D., et
al., Aqueous extract of valerian root (Valeriana officinalis L.)
improves sleep quality in man. Pharmacol Biochem Behav, 1982.17(1):
p. 65-71.).
[0048] The second, e.g., night-time, composition of the diet supplement
may include Valerian Root Extract (valeriana officianalis). A serving
of the second, e.g., nighttime, composition of the diet supplement
may include from about 1.0 mg to about 1000 mg of Valerian Root
Extract (valeriana officianalis). In a preferred dosage, a serving
of the second, e.g., nighttime, composition of the diet supplement
comprises about 150 mg of Valerian Root Extract (valeriana officianalis).
[0049] Melatonin
[0050] Melatonin is a hormone produced by the pineal gland and
is derived from tryptophan. It is involved in sleep regulation and
is often used to treat sleep disorders such as insomnia and `jet
lag`.
[0051] Melatonin has been shown to alleviate the symptoms of jet
lag (Petrie, K., et al., Effect of melatonin on jet lag after long
haul flights. Bmj, 1989. 298(6675): p. 705-7.; Suhner, A., et al.,
Effectiveness and tolerability of melatonin and zolpidem for the
alleviation of jet lag. Aviat Space Environ Med, 2001. 72(7): p.
63846.) is able to shift circadian rhythms, aiding in sleep (Lewy,
A. J., et al., Melatonin shifts human circadian rhythms according
to a phase-response curve. Chronobiol Int, 1992. 9(5): p. 380-92.;
Zhdanova, I. V., et al., Sleep-inducing effects of low doses of
melatonin ingested in the evening. Clin Pharmacol Ther, 1995. 57(5):
p. 552-8.; Hughes, R. J., R. L. Sack, and A. J. Lewy, The role of
melatonin and circadian phase in age-related sleep-maintenance insomnia:
assessment in a clinical trial of melatonin replacement. Sleep,
1998. 21(1): p. 52-68.). Melatonin has also be successfully been
used to treat seasonal depression (Lewy, A. J., et al., Melatonin
treatment of winter depression: a pilot study. Psychiatry Res, 1998.
77(1): p. 57-61.). Blood pressure and stress hormones have further
been shown to be reduced by the daily oral administration of melatonin
in healthy men (Arangino, S., et al., Effects of melatonin on vascular
reactivity, catecholamine levels, and blood pressure in healthy
men. Am J Cardiol, 1999. 83(9): p. 1417-9.). In mice, melatonin
has been shown to reduce diet-induced weight gain (Prunet-Marcassus,
B., et al., Melatonin reduces body weight gain in Sprague Dawley
rats with diet-induced obesity. Endocrinology, 2003. 144(12): p.
5347-52.).
[0052] In addition or alternatively, the second, e.g., night-time,
composition of the diet supplement may include Melatonin. A serving
of the second, e.g., nighttime, composition of the diet supplement
may include from about 0.1 mg to about 100 mg of Melatonin. In a
preferred dosage, a serving of the second, e.g., nighttime, composition
of the diet supplement comprises about 3 mg of Melatonin.
[0053] Chamomile
[0054] Chamomile is a popular herbal ingredient, wherein it is
typically served as a tea. It is primarily known as a relaxant as
well as a calming agent.
[0055] Ingesting chamomile tea results in indications of boosted
immunity in humans (Wang, Y., et al., A metabonomic strategy for
the detection of the metabolic effects of chamomile (Matricaria
recutita L.) ingestion. J Agric Food Chem, 2005. 53(2): p. 191-6.).
Studies in mice indicate that Chamomile has anti-allergic properties
(Kobayashi, Y., et al., Dietary intake of the flower extracts of
German chamomile (Matricaria recutita L.) inhibited compound 48/80-induced
itch-scratch responses in mice. Phytomedicine, 2003. 10(8): p. 657-64.).
Chamomile may also have anti-chemical dependence properties according
to studies in rats (Gomaa, A., et al., Matricaria chamomilla extract
inhibits both development of morphine dependence and expression
of abstinence syndrome in rats. J Pharmacol Sci, 2003. 92(1): p.
50-5.).
[0056] Chamomile is known for inducing relaxation and possessing
anxiolytic properties. Compounds present in Chamomile Extracts,
namely Apigenin can bind to the benzodiazepine binding site in the
gamma-aminobutyric acid receptor type A (GABA(A)) (Fernandez, S.
P., et al., Synergistic interaction between hesperidin, a natural
flavonoid, and diazepam. Eur. J. Pharmacol., 2005. 512(2-3): p.
189-98). The action of this ligand leads to sedation and a reduction
in locomotor activity (Avallone, R. et al., Pharmacological profile
of apigenin, a flavonoid isolated from Matricadia chamomilla. Biochem.
Pharmacol. 2000. 59(11): p. 1387-94) without impairing memory or
motor skills (Salgueiro, J. B., et al., Anxiolytic natural and synthetic
flavonoid ligands of the central benzodiazepine receptor have no
effect on memory tasks in rats. Pharmacol. Biochem. Behav., 1997.
58(4): p. 887-91).
[0057] The second, e.g., night-time, composition of the diet supplement
may include chamomile, e.g., Chamomile from flower (matricaria recutita).
A serving of the second, e.g., nighttime, composition of the diet
supplement may include from about 0.1 mg to about 100 mg of Chamomile,
e.g., Chamomile from flower (matricaria recutita). In a preferred
dosage, a serving of the second, e.g., nighttime, composition of
the diet supplement comprises about 1 mg of Chamomile, e.g., Chamomile
from flower (matricaria recutita).
[0058] Passionflower
[0059] Passionflower is used as a sleep-aid in addition to a treatment
for anxiety. Clinical studies have shown Passionflower has benefits
as a treatment for opiate-withdrawal (Akhondzadeh, S., et al., Passionflower
in the treatment of opiates withdrawal: a double-blind randomized
controlled trial. J Clin Pharm Ther, 2001. 26(5): p. 369-73.) and
anxiety treatment (Akhondzadeh, S., et al., Passionflower in the
treatment of generalized anxiety: a pilot double-blind randomized
controlled trial with oxazepam. J Clin Pharm Ther, 2001. 26(5):
p. 363-7.). In rats, Passionflower has been shown to be a potent
sedative (Capasso, A. and L. Sorrentino, Pharmacological studies
on the sedative and hypnotic effect of Kava kava and Passiflora
extracts combination. Phytomedicine, 2005. 12(1-2): p. 39-45.).
Moreover, it contains a compound that is a known ligand for benzodiazepine
receptors (Medina, J. H., et al., Chrysin (5,7-di-OH-flavone), a
naturally-occurring ligand for benzodiazepine receptors, with anticonvulsant
properties. Biochem Pharmacol, 1990. 40(10): p. 2227-31.), which
typically convey relaxation signals.
[0060] The second, e.g., night-time, composition of the diet supplement
may include passionflower, e.g., Passionflower from aerial parts
(passiflora incarnate). A serving of the second, e.g., nighttime,
composition of the diet supplement may include from about 0.01 g
to about 1 g of passionflower, e.g., Passionflower from aerial parts
(passiflora incarnate). In a preferred dosage, a serving of the
second, e.g., nighttime, composition of the diet supplement comprises
about 0.150 g of, e.g., Passionflower from aerial parts (passiflora
incarnate).
[0061] The diet supplement according to this invention provides
a method for causing fast weight loss, improving daytime energy,
promoting nighttime relaxation and sleep, controlling appetite and/or
increasing metabolism. Advantageously, consumption of the diet supplement
is combined with a reduced calorie diet and a program of regular
exercise.
[0062] According to various embodiments of the present invention,
the diet supplement may be consumed in any form. For instance, the
dosage form of the diet supplement may be provided as, e.g., a powder
beverage mix, a liquid beverage, a ready-to-eat bar or drink product,
a capsule, a tablet, a caplet, or as a dietary gel.
[0063] Preferably, the diet supplement is consumed by an individual
in accordance with the following: As a dietary supplement, 2 caplets
of the first, e.g., daytime, composition of the diet supplement
may be taken with an 8 oz. glass of water approximately 30 to 60
minutes before breakfast. In addition, 2 caplets of the first, e.g.,
daytime, composition of the diet supplement may be taken with an
8 oz. glass of water approximately 30 to 60 minutes before lunch.
Thereafter, 2 caplets of the second, e.g., nighttime, composition
of the diet supplement may be taken with an 8 oz. glass of water
approximately 30 to 60 minutes before dinner.
[0064] According to an embodiment of the present invention, the
diet supplement is provided to a mother, e.g., a new mother shortly
after childbirth, for causing fast weight loss, improving daytime
energy, promoting nighttime relaxation and sleep, controlling appetite
and/or increasing metabolism. For example, in an example embodiment,
the first, e.g., daytime, composition of the diet supplement may
be consumed by a new mother approximately 30 to 60 minutes before
breakfast, wherein the first, e.g., daytime, composition of the
diet supplement is formulated for causing fast weight loss, improving
daytime energy, controlling appetite and/or increasing metabolism.
In addition, the first, e.g., daytime, composition of the diet supplement
may be consumed by a new mother approximately 30 to 60 minutes before
lunch. Thereafter, the second, e.g., nighttime, composition of the
diet supplement may be consumed by a new mother approximately 30
to 60 minutes before dinner, wherein the second, e.g., nighttime,
composition of the diet supplement is formulated for causing fast
weight loss, promoting nighttime relaxation and sleep, controlling
appetite and/or increasing metabolism. In this manner, the various
different compositions of the diet supplement may provide an appropriate
benefit for all 24 hours of the day.
[0065] Furthermore, the dosage form of the diet supplement may
be provided in accordance with customary processing techniques for
herbal and/or dietary supplements in any of the forms mentioned
above.
[0066] As set forth above, in one embodiment, the present invention
provides, by the consumption of the diet supplement, a method for
causing fast weight loss, improving daytime energy, promoting nighttime
relaxation and sleep, controlling appetite and/or increasing metabolism.
For example, the present invention provides, by the consumption
of a first, e.g., daytime, composition of the diet supplement, a
method for causing fast weight loss, improving daytime energy, controlling
appetite and/or increasing metabolism. Furthermore, the present
invention provides, by the consumption of a second, e.g., nighttime,
composition of the diet supplement, a method for causing fast weight
loss, promoting nighttime relaxation and sleep, controlling appetite
and/or increasing metabolism.
[0067] The diet supplement set forth in the example embodiments
herein may contain any appropriate number and type of excipients,
as is well known in the art.
[0068] In addition, the present invention relates to a method of
manufacturing a diet supplement for causing fast weight loss, improving
daytime energy, promoting nighttime relaxation and sleep, controlling
appetite and/or increasing metabolism. In accordance with one embodiment,
the method of manufacturing the diet supplement may include the
substeps of manufacturing a first, e.g., daytime, composition and
a second, nighttime, composition of the diet supplement. For example,
the substep of manufacturing a first, e.g., daytime, composition
of the diet supplement may include the step of mixing one or more
of Garcinia Cambogia, Green Tea Dry Leaf Extract (camellia sinensis),
Anhydrous Caffeine, Chromium Polynicotinate, Gymnema Sylvestre Leaf
Extract, Enriched Soy Phospholipids, and Griffonia Simplicifolia
Seed Extract. The substep of manufacturing the first, e.g., daytime,
composition of the diet supplement may also include the step of
checking for uniformity/homogeneity. In addition, the substep of
manufacturing the first, e.g., daytime, composition of the diet
supplement, may include the step of aliquoting the mixture into
a serving for compression into a caplet.
[0069] Furthermore, the substep of manufacturing a second, e.g.,
nighttime, composition of the diet supplement may include the step
of mixing one or more of Garcinia Cambogia, Valerian Root Extract,
Gymnema Sylvestre Leaf Extract, Melatonin, Chromium Polynicotinate,
Chamomile and Passionflower. The substep of manufacturing the second,
e.g., nighttime, composition of the diet supplement may also include
the step of checking for uniformity/homogeneity. In addition, the
substep of manufacturing the second, e.g., nighttime, composition
of the diet supplement, may include the step of aliquoting the mixture
into a serving for compression into a caplet.
[0070] Although the following example illustrates the practice
of the present invention in one of its embodiments, the example
should not be construed as limiting the scope of the invention.
Other embodiments will be apparent to one skilled in the art from
consideration of the specification of the following example.
EXAMPLES
Example 1
[0071] A diet supplement formulation for promoting fast weight
loss and improving daytime energy is provided comprising the Calcium
and Potassium double salt of Garcinia Cambogia Extract standardized
to 60% Hydroxycitric Acid (1.55500 g), Extract Green Tea Leaf Extract
(0.30444 g) standardized to 45% EGCG, 75% Catechins, 90% Polyphenols,
Anhydrous Caffeine (0.07500 g), Chromium Polynicotinate (0.00133
g), Gymnema Sylvestre Extract (0.13300 g) standardized to 25% Gymnemic
Acids, Enriched Soy Phospholipids (0.00100 g) standardized to 50%
Phosphatidyl Serine, standardized to 4% Phosphatidyl Choline, 2%
Phosphatidyl Ethanolamine and Griffonia Simplicifolia Extract (0.02000
g) standardized to 95% 5-HTP. The present embodiment, taken as a
daytime supplement, may improve daytime energy, while controlling
appetite and increasing metabolism.
[0072] Directions: As a diet supplement, 2 caplets of the daytime
formulation of the diet supplement may be taken with an 8 oz. glass
of water approximately 30 to 60 minutes before breakfast. As a second
daily administration, 2 caplets of the daytime formulation of the
diet supplement may be taken with an 8 oz. glass of water approximately
30 to 60 minutes before lunch.
Example 2
[0073] A diet supplement for promoting fast weight loss and promoting
nighttime relaxation is provided comprising the Calcium and Potassium
double salt of Garcinia Cambogia Extract standardized to 60% Hydroxycitric
Acid (1.182 g), Passionflower (0.150 g) supplying 3.5% flavanoids,
Gymnema Sylvestre Extract (0.13300 g) standardized to 25% Gymnemic
Acids, Melatonin (0.003 g), Chromium Polynicotinate (0.000133 g),
Chamomile Extract (0.001 g) standardized to 1.2% Apigenin, Valerian
Root Extract (0.0001 g) standardized to 0.8% Valerenic Acids in
a formulation. The present embodiment, taken as a nighttime supplement,
may induce relaxation and sleep, while controlling appetite and
increasing metabolism.
[0074] Directions: As a diet supplement, 2 caplets of the nighttime
formulation of the diet supplement may be taken with an 8 oz. glass
of water approximately 30 to 60 minutes before dinner. |