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Weight Loss Patent Abstract
A diet supplement comprising at least Green Tea Extract and Oolong
Tea Extract may be in a time-release mechanism for sustained all-day
energy, burning of calories, supporting weight loss, and improving
mental focus. A method for providing sustained all-day energy, burning
of calories, weight loss support, and improved mental focus by consumption
of the diet supplement is also provided.
Weight Loss Patent Claims
1. A diet supplement comprising Green Tea Extract and Oolong Tea
Extract.
2. The diet supplement of claim 1, further comprising White Tea
Extract.
3. The diet supplement of claim 2, wherein the Green Tea Extract
is Green Tea Dry Leaf Extract, the White Tea Extract is White Tea
Dry Leaf Extract, and the Oolong Tea Extract is Oolong Tea Dry Leaf
Extract.
4. The diet supplement of claim 3, further comprising Anhydrous
Caffeine.
5. The diet supplement of claim 4, further comprising a time-release
mechanism.
6. The diet supplement of claim 5, wherein the time-release mechanism
provides for up to and including 12 hours active compound release.
7. The diet supplement of claim 4, wherein the Green Tea Dry Leaf
Extract is present in amounts from about 0.01 g to about 2 g, the
Anhydrous Caffeine is present in amounts from about 0.001 g to about
1 g, the White Tea Dry Leaf Extract is present in amounts from about
0.0001 g to about 0.01 g and the Oolong Tea Dry Leaf Extract is
present in amounts from about 0.0001 to about 0.01 g per serving.
8. The diet supplement of claim 4, wherein the Green Tea Dry Leaf
Extract, Anhydrous Caffeine, White Tea Dry Leaf Extract and Oolong
Tea Dry Leaf Extract are present in amounts effective for at least
one of burning calories, providing sustained energy, supporting
weight loss and improving mental focus in a human or animal.
9. A method for at least one of burning calories, providing sustained
energy, supporting weight loss and improving mental focus in a human
or animal, comprising the step of administering to the human or
animal a diet supplement that comprises Green Tea Extract and Oolong
Tea Extract.
10. The method of claim 9, wherein the diet supplement further
comprises White Tea Extract.
11. The method of claim 10, wherein the Green Tea Extract is Green
Tea Dry Leaf Extract, the White Tea Extract is White Tea Dry Leaf
Extract, and the Oolong Tea Extract is Oolong Tea Dry Leaf Extract.
12. The method of claim 11, wherein the diet supplement further
comprises Anhydrous Caffeine.
13. The method of claim 12, wherein the diet supplement is provided
in a time release mechanism.
14. The method of claim 13, wherein the time-release mechanism
provides for up to and including 12 hours active compound release.
15. The method of claim 12, wherein the diet supplement is administered
to the human or animal within at least one hour of waking in the
morning.
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. 60/688,420 entitled "Diet Supplement for Burning Additional
Calories, Providing Sustained Energy, Supporting Weight Loss, and/or
Improving Mental Focus" filed Jun. 7, 2005, the disclosure
of which is hereby fully incorporated by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to a diet supplement for burning
additional calories, providing sustained energy, supporting weight
loss, and/or improving mental focus. Preferably, the diet supplement
is provided in a time-release form for burning additional calories,
providing sustained energy, supporting weight loss, and/or improving
mental focus for an extended period of time throughout the day,
e.g., an entire work day. In addition, the present invention relates
to a method of promoting same by consuming the diet supplement.
SUMMARY OF THE INVENTION
[0003] The present invention provides for a diet supplement that
burns additional calories, provides sustained energy, supports weight
loss, and/or improves mental focus. The diet supplement may include
Caffeine Anhydrous. In addition or alternatively, the diet supplement
may include one or more of Green Tea Dry Leaf Extract, White Tea
Dry Leaf Extract and/or Oolong Tea Dry Leaf Extract. In one embodiment
of the present invention, the diet supplement includes Green Tea
Dry Leaf Extract and Caffeine Anhydrous in equal quantities. Advantageously,
the diet supplement is provided in a time-release form, for burning
additional calories, providing sustained energy, supporting weight
loss, and/or improving mental focus for an extended period of time,
e.g., up to 12 hours, so as to be an all-work day formula, after
being consumed by an individual.
[0004] The present invention also provides, by the consumption
of the supplemental composition, a method of burning additional
calories, providing sustained energy, supporting weight loss, and/or
improving mental focus.
DETAILED DESCRIPTION OF THE INVENTION
[0005] The present invention, according to various embodiments
thereof, is directed to a diet supplement that burns additional
calories, provides sustained energy, supports weight loss, and/or
improves mental focus.
[0006] Advantageously, the diet supplement is provided in a time-release
form, for burning additional calories, providing sustained energy,
supporting weight loss, and/or improving mental focus for an extended
period of time after being consumed by an individual. For example,
in an example embodiment, the diet supplement is provided in a time-release
form that has a time release of approximately eight hours. is Thus,
for an embodiment that includes caffeine having a half-life of approximately
4 hours, each serving of the diet supplement may burn additional
calories, provide sustained energy, support weight loss, and/or
improve mental focus for up to 12 hours after being consumed by
an individual. In this manner, the diet supplement may provide an
all-work day formula in that it may burn additional calories, provide
sustained energy, support weight loss, and/or improve mental focus
throughout an entire "work-day" of a typical individual.
[0007] Green Tea Dry Leaf Extract
[0008] All teas of which the diet supplement of the present invention
may be comprised, for example e.g., Green Tea, White Tea and Oolong
Tea, are derived from the same plant namely Camellia sinensis. However,
through the use of different processing methods, different proportions
of active compounds result in each of the respective teas. White
Tea undergoes very little processing, as does Green Tea, thereby
leavsing a relatively large amount of active compounds. Unlike green
tea however, white tea is harvested before the leaves are fully
opened. The processing of Oolong Tea is typically more involved
than that of green tea. The active compounds of tea are a family
of polyphenols, particularly the Catechins. The most active specific
compound is the Catechin, epigallocatechin gallate (ECGC) which
comprises from about 10 to about 50% of the total Catechins (Kao
Y H, Hiipakka R A, Liao S. Modulation of endocrine systems and food
intake by green tea epigallocatechin gallate. Endocrinology. 2000
March; 141(3):980-7.). Furthermore, Green Tea also contains caffeine,
although typically significantly less than Black Tea. Green tea
and the active compounds isolated from Green Tea are the most widely
studied teas to date.
[0009] The principal beneficial activity of Green Tea imparted
by polyphenols is its antioxidant activity as evidenced by several
studies. One clinical study has shown that ingestion of green tea
extract results in a rapid increase in plasma antioxidant activity
(Benzie I F, Szeto Y T, Strain J J, Tomlinson B. Consumption of
green tea causes rapid increase in plasma antioxidant power in humans.
Nutr Cancer. 1999; 34(1):83-7.). Green tea has also been shown to
be effective in aiding weight loss (Chantre P, Lairon D. Recent
findings of green tea extract AR25 (Exolise) and its activity for
the treatment of obesity. Phytomedicine. 2002 January; 9(1):3-8.).
This effect may be due to two activities. Firstly, Green Tea reduces
fat digestion and secondly it increases energy expenditure (Berube-Parent
S, Pelletier C, Dore J, Tremblay A. 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 September; 94(3):432-6.). The increase in energy
expenditure may be derived from fat stores via the oxidation of
fat, resulting in 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 November; 14(11):671-6.; Dulloo A G, Duret C, Rohrer D, Girardier
L, Mensi N, Fathi M, Chantre P, Vandermander J. 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 December; 70(6):1040-5.). The thermogenic activity of Green
Tea may additionally be greatly enhanced by its synergistic cooperation
with caffeine (Dulloo A G, Seydoux J, Girardier L, Chantre P, Vandermander
J. Green tea and thermogenesis: interactions between catechin-polyphenols,
caffeine and sympathetic activity. Int J Obes Relat Metab Disord.
2000 February; 24(2):252-8.). Moreover, an inverse relationship
has also been demonstrated with respect to Green Tea consumption
and total cholesterol levels (Kono S, Shinchi K, Ikeda N, Yanai
F, Imanishi K. Green tea consumption and serum lipid profiles: a
cross-sectional study in northern Kyushu, Japan. Prev Med. 1992
July; 21(4):526-31.).
[0010] The mechanism of action for fat loss resulting from Green
Tea consumption 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, Huber
J A. Catechol O-methyltransferase. 5. Structure-activity relationships
for inhibition by flavonoids. J Med Chem. 1975 January; 18(1):120-2.).
In turn, norepinephrine inhibits degradation of intracellular cyclic
AMP (cAMP), an important signaling molecule involved in many metabolic
processes including thermogenesis. EGCG has been shown to be an
inhibitor of glutamate dehydrogenase, which regulates insulin secretion
(Li C, Allen A, Kwagh J, Doliba NM, Qin W, Najafi H, Collins H W,
Matschinsky F M, Stanley C A, Smith T J. Green tea polyphenols modulate
insulin secretion by inhibiting glutamate dehydrogenase. J Biol
Chem. 2006 Apr. 14; 281(15):10214-21. Epub 2006 Feb. 13.). The Anticancer
activities associated with Green Tea may be related to its antioxidant
activity and inhibition of vascular endothelial growth factor (VEGF)
receptor signaling, which plays a role in tumor angiogenesis (Lamy
S, Gingras D, Beliveau R. Green tea catechins inhibit vascular endothelial
growth factor receptor phosphorylation. Cancer Res. 2002 Jan. 15;
62(2):381-5.; Lee Y K, Bone N D, Strege A K, Shanafelt T D, Jelinek
D F, Kay N E. VEGF receptor phosphorylation status and apoptosis
is modulated by a green tea component, epigallocatechin-3-gallate
(EGCG), in B-cell chronic lymphocytic leukemia. Blood. 2004 Aug.
1; 104(3):788-94. Epub 2004 Mar. 2.).
[0011] The diet supplement may include Green Tea Dry Leaf Extract.
In one embodiment of the present invention, which is set forth in
greater detail in Example 1 below, the diet supplement may comprise
Green Tea Dry Leaf Extract wherein a serving includes from about
1 mg to about 2000 mg of Green Tea Dry Leaf Extract. The preferred
dosage of a serving of the diet supplement comprises about 600 mg
of Green Tea Dry Leaf Extract.
[0012] Additionally, in a second embodiment of the present invention,
which is set forth in greater detail in Example 2 below, the diet
supplement may comprise Green Tea Dry Leaf Extract wherein a serving
includes from about 1 mg to about 2000 mg of Green Tea Dry Leaf
Extract. The preferred dosage of a serving of the diet supplement
comprises about 598 mg of Green Tea Dry Leaf Extract.
[0013] In an embodiment of the present invention, the diet supplement
comprises Green Tea Dry Leaf Extract, wherein the Green Tea Dry
Leaf Extract comprises about 90% polyphenols. In one such embodiment
of the present invention, the diet supplement includes Green Tea
Dry Leaf Extract, wherein the Green Tea Dry Leaf Extract comprises
about 75% Catechins. Furthermore, in one such embodiment of the
present invention, the diet supplement comprises Green Tea Dry Leaf
Extract, wherein the Green Tea Dry Leaf Extract comprises about
45% epigallocatechin galrate ("EGCG").
[0014] In a second embodiment of the present invention, the diet
supplement comprises Green Tea Dry Leaf Extract, wherein the Green
Tea Dry Leaf Extract comprises about 98% polyphenols. In one such
embodiment of the present invention, the diet supplement includes
Green Tea Dry Leaf Extract, wherein the Green Tea Dry Leaf Extract
comprises about 75% Catechins. Furthermore, in one such embodiment
of the present invention, the diet supplement comprises Green Tea
Dry Leaf Extract, wherein the Green Tea Dry Leaf Extract comprises
about 45% epigallocatechin gallate ("EGCG").
[0015] White Tea Dry Leaf Extract
[0016] White Tea is reported to have the same health benefits of
green tea. However, White Tea has been reported to impart these
benefits to an even greater extent (Santana-Rios G, Orner G A, Amantana
A, Provost C, Wu S Y, Dashwood R H. Potent antimutagenic activity
of white tea in comparison with green tea in the Salmonella assay.
Mutat Res. 2001 Aug. 22; 495(1-2):61-74.). White Tea has further
been shown to possess anticarcinogenic properties in rats (Santana-Rios
G, Orner G A, Xu M, Izquierdo-Pulido M, Dashwood R H. Inhibition
by white tea of 2-amino-1-methyl-6-phenylimidazo[4,5-b]pyridine-induced
colonic aberrant crypts in the F344 rat. Nutr Cancer. 2001; 41(1-2):98-103.).
A 6-month double blind, placebo controlled, randomized study on
healthy post-menopausal females demonstrated that a supplement containing
white tea improved skin condition, structure and firmness (Skovgaard
G R, Jensen A S, Sigler M L. Effect of a novel dietary supplement
on skin aging in post-menopausal women. Eur J Clin Nutr. 2006 May
3.). White tea, as shown by a bacterial virus inactivation assay,
has been reported to be more effective than Green Tea and to also
possess anti-fungal properties (Dr. Schiffenbauer, Pace University,
104th General Meeting of the American Society for Microbiology on
May 923, 2004, New Orleans, La.).
[0017] In addition or alternatively to the ingredients set forth
above, the diet supplement may include White Tea Dry Leaf Extract.
In an embodiment of the present invention, which is set forth in
greater detail in Example 1 below, the diet supplement may comprise
White Tea Dry Leaf Extract wherein a serving includes from about
0.1 mg to about 1000 mg of White Tea Dry Leaf Extract. The preferred
dosage of a serving of the diet supplement comprises about 1.56
mg of White Tea Dry Leaf Extract.
[0018] In addition or alternatively to the ingredients set forth
above, the diet supplement, in a second embodiment may include White
Tea Dry Leaf Extract. In an embodiment of the present invention,
which is set forth in greater detail in Example 2 below, the diet
supplement may comprise White Tea Dry Leaf Extract wherein a serving
includes from about 0.1 mg to about 1000 mg of White Tea Dry Leaf
Extract. The preferred dosage of a serving of the diet supplement
comprises about 1.00 mg of White Tea Dry Leaf Extract.
[0019] In both embodiments of the present invention, the diet supplement
comprises White Tea Dry Leaf Extract, wherein the White Tea Dry
Leaf Extract comprises about 50% polyphenols. In one such embodiment
of the present invention, the diet supplement comprises White Tea
Dry Leaf Extract, wherein the White Tea Dry Leaf Extract comprises
about 35% Catechins. Furthermore, in one such embodiment of the
present invention, the diet supplement comprises White Tea Dry Leaf
Extract, wherein the White Tea Dry Leaf Extract comprises about
15% EGCG.
[0020] Oolong Tea Dry Leaf Extract
[0021] Oolong Tea has also been specifically studied for beneficial
activities. The chemopreventative activity has been demonstrated
in rats (Matsumoto N, Kohri T, Okushio K, Hara Y. Inhibitory effects
of tea catechins, black tea extract and oolong tea extract on hepatocarcinogenesis
in rat. Jpn J Cancer Res. 1996 October; 87(10):1034-8.) has been
experimentally shown. Employing a comparative study in rats, it
was found that Oolong Tea was superior in controlling weight as
compared to Green Tea, while Green Tea was more effective at lowering
total cholesterol (Kuo K L, Weng M S, Chiang C T, Tsai Y J, Lin-Shiau
S Y, Lin J K. Comparative studies on the hypolipidemic and growth
suppressive effects of oolong, black, pu-erh, and green tea leaves
in rats. J Agric Food Chem. 2005 Jan. 26; 53(2):480-9.). As a method
of weight control, clinical trials in humans have shown that Oolong
Tea increases metabolic rate and energy expenditure (Rumpler W,
Seale J, Clevidence B, Judd J, Wiley E, Yamamoto S, Komatsu T, Sawaki
T, Ishikura Y, Hosoda K. Oolong tea increases metabolic rate and
fat oxidation in men. J Nutr. 2001 November; 131(11):2848-52.; Komatsu
T, Nakamori M, Komatsu K, Hosoda K, Okamura M, Toyama K, Ishikura
Y, Sakai T, Kunii D, Yamamoto S. Oolong tea increases energy metabolism
in Japanese females. J Med Invest. 2003 August; 50(3-4):170-5.).
Clinical trials have further demonstrated the potential therapeutic
benefit of Oolong Tea as a treatment for diabetes (Hosoda K, Wang
M F, Liao M L, Chuang C K, Iha M, Clevidence B, Yamamoto S. Antihyperglycemic
effect of oolong tea in type 2 diabetes. Diabetes Care. 2003 June;
26(6):1714-8.) and coronary artery disease (Shimada K, Kawarabayashi
T, Tanaka A, Fukuda D, Nakamura Y, Yoshiyama M, Takeuchi K, Sawaki
T, Hosoda K, Yoshikawa J. Oolong tea increases plasma adiponectin
levels and low-density lipoprotein particle size in patients with
coronary artery disease. Diabetes Res Clin Pract. 2004 September;
65(3):227-34.).
[0022] In addition or alternatively to the ingredients set forth
above, the diet supplement may include Oolong Tea Dry Leaf Extract.
In an embodiment of the present invention, which is set forth in
greater detail in Example 1 below, the diet supplement may comprise
Oolong Tea Dry Leaf Extract wherein a serving includes from about
0.1 mg to about 1000 mg of Oolong Tea Dry Leaf Extract. The preferred
dosage of a serving of the diet supplement comprises about 1.56
mg of Oolong Tea Dry Leaf Extract.
[0023] In addition or alternatively to the ingredients set forth
above, the diet supplement, a second embodiment may include Oolong
Tea Dry Leaf Extract. In an embodiment of the present invention,
which is set forth in greater detail in Example 2 below, the diet
supplement may comprise Oolong Tea Dry Leaf Extract wherein a serving
includes from about 0.1 mg to about 1000 mg of Oolong Tea Dry Leaf
Extract. The preferred dosage of a serving of the diet supplement
comprises about 1.00 mg of Oolong Tea Dry Leaf Extract.
[0024] In both embodiments of the present invention that are set
forth above, the diet supplement comprises Oolong Tea Dry Leaf Extract,
wherein the oolong tea dry leaf extract comprises about 50% polyphenols.
In one such embodiment of the present invention, the diet supplement
comprises Oolong Tea Dry Leaf Extract, wherein the Oolong Tea Dry
Leaf Extract comprises about 25% Catechins. Furthermore, in one
such embodiment of the present invention, the diet supplement comprises
Oolong Tea Dry Leaf Extract, wherein the Oolong Tea Dry Leaf Extract
comprises about 15% EGCG.
[0025] Anhydrous Caffeine
[0026] Anhydrous Caffeine is a naturally occurring xanthine alkaloid
found in some plants, where it acts 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.
Biochemically, caffeine which is structurally similar to adenosine
receptors, binds to, but does not activate, adenosine receptors
which are normally activated by adenosine to induce sleep (Shi D,
Nikodijevic O, Jacobson K A, Daly J W. Chronic caffeine alters the
density of adenosine, adrenergic, cholinergic, GABA, and serotonin
receptors and calcium channels in mouse brain. Cell Mol Neurobiol.
1993 June; 13(3):247-61.). This antagonism of adenosine receptors
leads to increased levels of neurotransmilters.
[0027] A meta-analysis compiled from forty double-blind studies
support the use of Caffeine to increase physical endurance (Doherty
M, Smith PM. Effects of caffeine ingestion on exercise testing:
a meta-analysis. Int J Sport Nutr Exerc Metab. 2004 December; 14(6):626-46.;
Graham T E, Hibbert E, Sathasivam P. Metabolic and exercise endurance
effects of coffee and caffeine ingestion. J Appl Physiol. 1998 September;
85(3):883-9.; Kovacs E M, Stegen J H C H, Brouns F. Effect of caffeinated
drinks on substrate metabolism, caffeine excretion, and performance.
J Appl Physiol. 1998 August; 85(2):709-15.). Furthermore, Caffeine
is also widely used to control weight, which may occur through multiple
mechanisms. Significant weight loss has been observed in obese women
related to caffeine supplementation (Yoshida T, Sakane N, Umekawa
T, Kondo M. 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 May; 18(5):345-50.) which may be, at least in
part, due to increased lipolysis as fat is metabolized (Jung R T,
Shetty P S, James W P, Barrand M A, Callingham B A. Caffeine: its
effect on catecholamines and metabolism in lean and obese humans.
Clin Sci (Lond). 1981 May; 60(5):527-35.). Caffeine has also been
shown to increase metabolic rate in both lean and obese individuals
(Roberts A T, de Jonge-Levitan L, Parker C C, Greenway F. The effect
of an herbal supplement containing black tea and caffeine on metabolic
parameters in humans. Altern Med Rev. 2005 December; 10(4):321-5.;
Astrup A, Toubro S, Cannon S, Hein P, Breum L, Madsen J. Caffeine:
a double-blind, placebo-controlled study of its thermogenic, metabolic,
and cardiovascular effects in healthy volunteers. Am j Clin Nutr.
1990 May; 51(5):759-67.; Dulloo A G, Geissler C A, Horton T, Collins
A, Miller D S. Normal caffeine consumption: influence on thermogenesis
and daily energy expenditure in lean and postobese human volunteers.
Am J Clin Nutr. 1989 January; 49(1):44-50.) wherein this adds to
its weight-lowering effects. Furthermore, caffeine additionally
improves cognitive performance following physical activity (Hogervorst
E, Riedel W J, Kovacs E, Brouns F, Jolles J. Caffeine improves cognitive
performance after strenuous physical exercise. Int J Sports Med.
1999 August; 20(6):354-61.).
[0028] In addition or alternatively to the ingredients set forth
above, the diet supplement may include Caffeine Anhydrous. In an
embodiment of the present invention, which is set forth in greater
detail in Examples 1 and 2 below, the diet supplement may comprise
Caffeine Anhydrous wherein a serving includes from about 1 mg to
about 2000 mg of Caffeine Anhydrous. The preferred dosage of a serving
of the diet supplement comprises about 400 mg of Caffeine Anhydrous.
Furthermore, in an embodiment of the present invention, the diet
supplement includes green tea dry leaf extract and caffeine anhydrous
in equal quantities.
[0029] The present invention, according to various embodiments
thereof, provides a method of burning additional calories, providing
sustained energy, supporting weight loss, and/or improving mental
focus by the consumption of the diet supplement. Advantageously,
consumption of the diet supplement is combined with a program of
diet and exercise.
[0030] 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. The most preferred
dosage form is a caplet.
[0031] Preferably, the diet supplement is consumed by an individual
in accordance with the following: As a diet supplement, 2 caplets
may be taken with an 8 oz. glass of water within one hour after
waking up in the morning. More than two caplets should not be consumed
by an individual in a 24-hour period. To assess individual tolerance,
an individual may consume, on Day 1 to Day 3, 1 caplet daily. Thereafter,
an individual may consume two caplets daily.
[0032] 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.
[0033] The diet supplement of the present invention may be provided
in a time release mechanism. U.S. Pat. No. 5,445,826, entitled "Delivery
System Containing a Gel-Forming Fiber and a Drug" discloses
a prolonged-release dosage formulation preferably in a tablet form.
The patent purports to describe a composition that includes a gel-forming
fiber, preferably hydrocolloid-coated, a biologically-absorbable
drug, or other active therapeutic agent which is also preferably
hydrocolloid-coated, and a mineral salt such as mineral carbonate
or bicarbonate which releases a physiologically-acceptable gas such
as carbon dioxide upon ingestion. The composition may optionally
also contain phosphoric acid and a dextrose or similar sugar. The
aforementioned fiber-containing coating, when in the form of a tablet
or other unit dosage form together with the drug or agent, provides
a controllable prolonged action drug-delivery system.
[0034] U.S. Pat. No. 5,292,518, entitled "Prolonged-Release
Drug Table Formulations" discloses a prolonged-release unit
dosage formulation or pharmaceutical composition. Preferably, the
unit dosage is in the form of a table wherein the composition consists
of a gel-forming dietary fiber, a biologically-absorbable drug or
other active therapeutic agent, and a disintegrant such a mineral
salt e.g. mineral carbonate or bicarbonate, which releases a physiological
acceptable gas such as carbon dioxide upon ingestion, and advantageously
dextrose or similarly soluble sugar. Furthermore, a physiologically-acceptable
acid may optionally be included in the composition to further facilitate
the disintegration of the tablet. The dietary fiber-containing composition,
when compressed into a table together with the drug and specific
disintegrant, provides a prolonged-action drug-delivery system.
[0035] U.S. Pat. No. 5,096,714 entitled "Prolonged-release
Drug Tablet Formulations" purports to describe a composition
to provide a prolonged-action drug-delivery system. The invention
comprises a composition consisting of a gel-forming dietary fiber,
a biologically-absorbable drug or other active therapeutic agent,
disintegrants such as physiological-acceptable edible acids and
mineral salts; which upon ingestion release a physiological acceptable
gas such as carbon dioxide, as well as dextrose or a similarly soluble
sugar. The unit dosage according to the present invention is a tablet.
[0036] A study designed to assess the effectiveness of the pharmacokinetics
of extended release Caffeine tablets was performed. The study was
a single-site, open label, phase 1 study involving 30 healthy subjects
with no known allergies or hypersensitivity to Caffeine. Subjects
first visited the study site for an initial screening and to consent
to the study and on a second occasion to the clinic for Caffeine
dosing. According to the dosage schedule, subject was asked to refrain
from Caffeine intake for 48 hours prior to the second visit.
[0037] Subjects were dosed with 600 mg Caffeine in extended-release
capsules and blood sample were taken at 0, 0.5, 1, 2, 3, 6, 8, 10,
11, and 12 hours via an 18-gauge arm-inserted catheter. Urine was
collected at 0, 6, and 12 hours.
[0038] The half-life of the extended-release Caffeine capsule for
the pooled subjects was 7.09 hours. Five subjects had kinetic that
did not allow for a calculation of the half-life and were excluded
from the pooled subjects. As a comparison, the accepted half-life
for Caffeine in a non-extended release format is 3.5 to 5 hours.
Utilizing the extend-release format, the release period is approximately
70% longer that the non-extended release format. Furthermore, the
maximum concentration of the Caffeine in the serum was 5.76 mg/l
with a T.sub.max median and mode of 3 hours.
[0039] In the present invention, two examples of which are set
forth in greater detail in Examples 1 and 2 below, a diet supplement
is provided for burning additional calories, providing sustained
energy, supporting weight loss, and/or improving mental focus. In
this manner, consumption by an individual of the supplemental composition
provides for a method for burning additional calories, providing
sustained energy, supporting weight loss, and/or improving mental
focus. According to the example embodiment set forth below, the
diet supplement is provided and consumed in the form of a time-release
tablet.
[0040] The diet supplement set forth in the example embodiment
below may contain one or more of the following excipients: guar
gum, dicalcium phosphate, calcium carbonate, microcrystalline cellulose,
stearic acid, vegetable stearin, citrus pectin, magnesium stearate,
silica and film coating (hypromellose, hydroxypropyl cellulose,
and polyethylene glycol).
[0041] Although the following examples illustrate the practice
of the present invention in two of its embodiments, the examples
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 examples.
EXAMPLES
Example 1
[0042] A diet supplement formula for promoting the burning of additional
calories, providing sustained energy, supporting weight loss, and/or
improves mental focus is provided comprising Green Tea Dry Leaf
Extract (0.60000 g) standardized to 45% EGCG, 75% Catechins, 90%
Polyphenols, Anhydrous Caffeine (0.40000 g), White Tea Dry Leaf
Extract (0.00156 g) standardized to 15% EGCG, 35% Catechins, 50%
Polyphenols, and Oolong Tea Dry Leaf Extract (0.00156 g) standardized
to 15% EGCG, 25% Catechins, 50% Polyphenols. The present embodiment,
taken as a daytime supplement, may provide sustained energy, improve
mental focus as well as support weight loss by adding in the burning
of additional calories.
[0043] Directions: As a dietary supplement, 2 caplets may be taken
with an 8 oz. glass of water within one hour following waking in
the morning.
Example 2
[0044] A diet supplement formula for promoting the burning of additional
calories, providing sustained energy, supporting weight loss, and/or
improves mental focus is provided comprising Green Tea Dry Leaf
Extract (0.59800 g) standardized to 45% EGCG, 75% Catechins, 90%
Polyphenols, Anhydrous Caffeine (0.40000 g), White Tea Dry Leaf
Extract (0.00100 g) standardized to 15% EGCG, 35% Catechins, 50%
Polyphenols, and Oolong Tea Dry Leaf Extract (0.00100 g) standardized
to 15% EGCG, 25% Catechins, 50% Polyphenols. The present embodiment,
taken as a daytime supplement, may provide sustained energy, improve
mental focus as well as support weight loss by adding in the burning
of additional calories.
[0045] Directions: As a dietary supplement, 2 caplets may be taken
with an 8 oz. glass of water within one hour following waking in
the morning.
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