Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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COMPOSITIONS AND METHODS FOR INCREASING HUMAN GROWTH
HORMONE LEVELS
PRIORITY CLAIM
This application claims the benefit of the filing date of: United States
Patent
Application Serial Number 13/623,114, filed September 20, 2012, for "METHODS
FOR INCREASING HUMAN GROWTH HORMONE LEVELS"; United States
Patent Application Serial Number 13/623,117, filed September 20, 2012, for
"COMPOSITIONS FOR INCREASING HUMAN GROWTH HORMONE
LEVELS"; United States Patent Application Serial Number 13/623,118, filed
September 20, 2012, for "METHODS FOR INCREASING ENDURANCE AND
FAT METABOLISM IN HUMANS"; and United States Patent Application Serial
Number 13/623,112, filed September 20, 2012, for "COMPOSITIONS AND
METHODS FOR INCREASING HUMAN GROWTH HORMONE LEVELS."
TECHNICAL FIELD
Embodiments of the invention generally relate to compositions and methods for
increasing human growth hormone (hGH) levels in healthy human beings and for
increasing endurance and fat metabolism in humans.
BACKGROUND
The primary biological function of hGH includes stimulating growth, cell
repair and regeneration. Once the growth period of adolescence concludes, the
primary
function of hGH in adulthood becomes that of cell regeneration and repair,
helping to
regenerate skin, bones, heart, lungs, liver and kidneys to their optimal,
youthful cell
levels. As is the case with many of our other hormones or their pre-cursors,
such as
testosterone, estrogen, progesterone, DHEA and melatonin, hGH levels decline
with
age. Therapeutically, many of these hormones can be replaced to offset some of
the
effects of aging such as menopausal symptoms in women or erectile dysfunction
in
men. The human body, like every other living entity, works on daily, or
circadian, as
well as monthly and annual rhythms. Daily growth hormone secretion diminishes
with
age with roughly half the levels at age forty that we had when we were twenty,
and
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about one-third of those youthful levels at age sixty. In some sixty-year
olds, the levels
are as low as 25% of the hGH levels in a twenty-year old. Symptoms of aging
include
loss of muscle, increase of fat, decreased physical mobility, decreased energy
levels
and as a result, diminished socialization, diminished healing ability and an
increased
risk of cardiovascular disease and decreased life expectancy. Low hGH levels
are
associated with the aging process and early onset of disease. For example,
Rosen and
Bengtsson noted an increased death rate from cardiovascular disease in hGH
deficient
patients (Rosen, T., Bengtsson, B. A., Lancet 336 (1990): 285-2880).
Until recently human growth hormone (hereinafter alternatively referred to as
hGH) was available only in expensive injectable forms, and benefits from the
restoration of hGH levels available only to those with the ability to pay.
Most recently
natural substances that can trigger the release of human growth hormone from
an
individual's own anterior pituitary gland have become available. These are
generically
referred to as secretagogues. Secretagogues have the ability to restore hGH
levels,
potentially to the levels found in youth. See for reference the book entitled
"Grow
Young With hGH" by Dr. Ronald Klatz, President of the American Academy of
Anti-Aging, published in 1997 by Harper Collins.
HGH-deficient adults have marked reductions in lean body mass, and within
months of hGH treatment, gains in lean body mass, skin thickness and muscle
mass are
observed. (Cuneo RC et al. J Appl Physiol 1991;70:695-700; Cuneo RC et al. J
Appl
Physiol 1991;70:688-694; Rudman D et al. N Engl J Med 1969;280:1434-1438).
It is well-established that intravenous (IV) administration of some amino
acids
results in significant hGH secretion. Intravenous infusion of 183mg of
argininelg
body weight in females increased hGH levels >20-fold and 30g of arginine
elevated
serum hGH levels 8.6 fold in males. (Merimee TJ et al. N Engl J Med
1969;280:1434-1438; Alba-Roth J et al. J Clin Endocrinol Metab 1988;67:1186-
1189).
Other amino acids, such as methionine, phenylalanine, lysine, histidine, and
omithine
have also led to marked increases in hGH (Alba-Roth, Muller, Schopohl, & von
Werder, 1988; Chromiak & Antonio, 2002; Gourmelen, M., M. Donnadieu, et al.
(1972) Ann Endocrinol (Paris) 33(5): 526-528).
Given the difficulties in IV administration of amino acids for widespread use,
interest in elucidating the hGH response to oral amino acid supplements
prompted
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testing of such supplements containing mainly arginine, lysine and ornithine
at varying
amounts. Yet the pronounced variability in results among these studies, which
differed
in aspects including subject population, supplement composition, and dosage
methodologies, make clear the complexities involved in the design of an
effective
supplement for supporting hGH levels in the general public. (Surninski RR et
al. Int J
Sport Nutr 1997;7:48-60; Lambert MI et al. Int J Sport Nutr 1993;3:298-305;
Corpas E
et al. J Gerontol 1993;48:M128-M133; Isidori A et al. Curr Med Res Opin
1981;7:475-481; Fogelholm GM et al. Int J Sport Nutr 1993;3:290-297; Chromiak
JA,
Antonio J. Nutrition 2002 Jul;18(7-8):657-61).
Thus, determination of an effective and safe oral functional blend that
stimulates hGH secretion in the general population is important to determine
since
athletes, entertainers and now the general public seek effective hGH support
supplements and understand hGH to have rejuvenating properties.
Indeed, once partial to athletes and entertainers, the desire for effective
supplements to provoke growth hormone (hGH) increases now extends to the
general
public. Not only do they have a goal of building lean tissue and reducing fat,
but also
in improving skin quality and other rejuvenating qualities that hGH is
understood to
provide. Despite proceeding literature on oral amino acids for use in
stimulating hGH,
evidence for an optimized oral amino acid-containing blend able to stimulate
hGH in
the general public including both men and women of a wide age range is not
clear.
It would be desirable to provide a nutritional supplement for elevating hGH
release, in particular an amino acid-containing composition that is well
tolerated having
the result of increasing or elevating hGH release in those individuals whose
hGH
release rates have slowed as a function of increasing age or that have normal
hGH
levels but desire higher hGH levels. Although some existing nutritional
supplements
claim to impact the production of natural human growth hormone, there is a
need for
an improved nutritional supplement that efficiently enhances the production
and effect
of natural human growth hormone in the general population.
DISCLOSURE
81786847
3a
In some embodiments, there is provided a use of a nutritional supplement
orally to increase
endurance and fat metabolism in a human being, the nutritional supplement
comprising: 0.1 to
6 mmol L-arginine; 0.1 to 8 mmol Oxo-proline; 0.1 to 12 mmol L-lysine; 0.001
to 6 mmol
N-acetyl L-cysteine; and 0.001 to 6 mmol L-glutamine.
In some embodiments, there is provided a use of a nutritional supplement
orally to increase
endurance and fat metabolism in a human being, the nutritional supplement
comprising 3.44
mmol L-arginine; 5.30 mmol Oxo-proline; 8.21 mmol L-lysine; 6.13 pmol N-acetyl
L-cysteine; and 6.84 [tmol L-glutamine.
In some embodiments, there is provided a nutritional supplement for use orally
to increase
endurance and fat metabolism in a human being, the nutritional supplement
comprising: 0.1 to
6 mmol L-arginine; 0.1 to 8 mmol Oxo-proline; 0.1 to 12 mmol L-lysine; 0.001
to 6 mmol
N-acetyl L-cysteine; and 0.001 to 6 mmol L-glutamine.
In some embodiments, there is provided a nutritional supplement for use orally
to increase
endurance and fat metabolism in a human being, the nutritional supplement
comprising: 3.44
mmol L-arginine; 5.30 mmol Oxo-proline; 8.21 mmol L-lysine; 6.13 pmol N-acetyl
L cysteine; and 6.84 [tmol L-glutamine.
The nutritional supplements described herein may also include schizonepeta.
Date Recue/Date Received 2020-11-10
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The present invention relates to a nutritional supplement and method of using
the same. It is an amino acid-containing secretagogue composition, which,
taken orally,
stimulates the pituitary gland to increase serum levels of hGH.
Also described herein are nutritional supplement and method of using the same.
The nutritional supplement includes an amino acid secretagogue composition,
which,
taken orally, stimulates the pituitary gland to release hGH.
A particular embodiment of the present disclosure relates to an oral
nutritional
supplement that includes the amino acids 1-lysine, 1-arginine, oxo-proline,
and one of
either cysteine or glutamine. The amino acids may be delivered as non-toxic
salts
thereof, effective complexes thereof, stable chelates thereof, active esters
thereof,
functional derivatives thereof, and mixtures thereof which are effective to
increase
hGH levels in the general population.
Another particular embodiment relates to an oral nutritional supplement that
consists essentially of 1-lysine HC1, 1-arginine HC1, oxo-prolinc, N-acety1-1-
cysteine,
1-glutamine, and sehizonepeta (aerial parts) powder.
Other embodiments are drawn to methods of increasing human growth
hormone in humans that include orally administering the disclosed nutritional
supplement to a healthy human being. Alternative embodiments are drawn to
methods
of administering the disclosed nutritional supplements to a human being to
improve
endurance and fat metabolism.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows growth hormone levels after supplement administration
compared to a placebo.
MODE(S) FOR CARRYING OUT THE INVENTION
The present invention relates to a method of use of a nutritional supplement
by
a human being. The nutritional supplement is an amino acid-containing
secretagogue
composition, which, taken orally, stimulates the pituitary gland to produce
hGH.
Increased production of hGH may result in inhibition of insulin depression,
inhibition
of hyperglycemia and increase in insulin effectiveness, enhancement of fat
conversion,
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lowering of cholesterol, and normalization of lipid balance. The supplement of
the
present invention works as a dietary supplement by assisting the body's own
ability to
secrete hGH naturally in a manner which is safe and effective, as well as
being
affordable.
A particular embodiment of the present disclosure relates to an oral
nutritional
supplement that includes 1-lysine, 1-arginine, oxo-proline, and one of either
cysteine or
glutamine. The supplement may additionally include both cysteine and glutamine
and/or schizonepeta powder. In particular embodiments, a functional dosage
includes
the 1-arginine at a level between 0.1-6 mmol and the oxo-proline between 0.1-8
mmol,
and/or the 1-lysine in an amount between 0.1-12 mmol. The cysteine and/or
glutamine
may be contained at a level between 0.001-6 mmol. In another particular
embodiment,
a functional dosage includes the 1-arginine at a level between 2.5-4.5 mmol
and the
oxo-proline between 4-6 mmol, and/or the 1-lysine in an amount between 7-9
mmol.
The cysteine and/or glutamine may be contained at a level between 0.001-0.5
mmol.
The cysteine can be n-acetyl L-cysteine and the glutamine may be 1-glutamine.
The
amino acids may be delivered as non-toxic salts thereof, effective complexes
thereof,
stable chelates thereof, active esters thereof, functional derivatives
thereof, and
mixtures thereof which are effective to increase hGH levels in the general
population.
The nutritional supplement may be present in an amount of 2.9 grams. The
nutritional
supplement may be in any acceptable and known oral formulation, such as
powder,
tablet, capsule, liquid, or wafer form.
Another particular embodiment relates to an oral nutritional supplement that
consists essentially of 1-lysine HC1, 1-arginine HC1, oxo-proline, N-acetyl-l-
cysteine,
1-glutamine, and schizoncpeta (aerial parts) powder. In particular
embodiments, a
functional dosage includes the 1-arginine HC1 at a level between 0.1-6 mmol
and the
oxo-proline between 0.1-8 mmol, and/or the 1-lysine HC1 in an amount between
0.1-12 mmol. The n-acetyl L-cysteine and/or 1-glutamine may be contained at a
level
between 0.001-6 mmol. In another particular embodiment, a functional dosage
includes
the 1-arginine HC1 at a level between 2.5-4.5 mmol and the oxo-proline between
4-6 mmol, and/or the 1-lysine HCl in an amount between 7-9 mmol. The n-acetyl
L-cysteine and/or 1-glutamine may be contained at a level between 0.001-0.5
mmol.
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The nutritional supplement may be in any acceptable and known oral
formulation, such
as powder, tablet, capsule, liquid, or wafer form.
Other embodiments are drawn to methods of increasing human growth
hormone in humans that include orally administering the disclosed nutritional
supplement to a healthy human being. As used herein, "healthy human being"
means a
human being without any physiological deficiency in hGH independent of age.
Particular embodiments of the invention relate to oral administration of the
disclosed
nutritional supplement to a human that is at least 30 years old. The
nutritional
supplement may be administered from one to three times daily or,
alternatively, may be
administered every other day, or may be administered once a week. In
particular
embodiments, the nutritional supplement may be administered on an empty
stomach.
The disclosed nutritional supplements can be orally administering to a human
being to improve health, including by improving endurance and increasing fat
metabolism. The disclosed nutritional supplements can also be used in
combination
with testosterone or testosterone-boosting supplements to enhance the effect
of the
nutritional supplements disclosed herein.
In accordance with the "consist essentially of" and "consisting essentially
of"
language, the nutritional supplement of the third embodiments is essentially
limited to
the aforementioned ingredients and does not include any additional active
ingredients
intended to add nutritional content (e.g., vitamins, minerals, etc.), but may
include
additional ingredients not intended to add nutritional content such as
ingredients
intended to fulfill a non-nutritional purpose (e.g., coloring, fillers,
flavoring, an
ingredient for maintaining the structural form, etc.).
Each ingredient of the nutritional supplement of the present invention may be
prepared in accordance with any method known to one of ordinary skill in the
art.
Alternatively, each ingredient may be obtained in a fully prepared from a
commercially
available source.
The nutritional supplement of the present invention may be in any suitable
oral
administration form, including but not limited to: a chewable form, a liquid
form, a
spray form, a capsule form, a suppository form, dissolvable wafer, and a
powder form.
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Irrespective of the structural form of the nutritional supplement, the
ingredients
of the nutritional supplement may be distributed homogeneously or
non-homogeneously within the nutritional supplement.
The nutritional supplement of the present invention may be ingested on a
regular basis, such as a daily or weekly intake at a dosage tailored to an
individual's
needs; i.e., the nutritional supplement is to be taken regularly as multiples
(lx, 2x, etc.)
of the structural units (pills, tablets, capsules, liquid dose, etc.) in
accordance with the
needs of the individual. For example, a senior citizen leading a sedentary
life may need
higher daily doses than does a young person engaged in regular strenuous
exercise
(e.g., a weight lifter). Alternatively, the nutritional supplement of the
present invention
may be ingested on an as-needed basis at a dosage tailored to the individual's
needs.
Medical or nutritional counseling may be beneficial for arriving at a
desirable or
optimal dosage tailored to the individual's needs.
The combination of types of amino acids, mass ranges, and specific
formulations have been selected to be synergistically balanced and of adequate
quantity
to achieve the desired physiological effect, namely, growth hormone release.
Improper
combinations of the amino acids may be ineffective. The component amino acids
are
synergistic in the sense that several of them when combined together,
synergistically
stimulate the release of human growth hormone. The combination was also chosen
to
reduce or inhibit chemical combination or reaction between the amino acids.
EXAMPLES
Example 1
A cross-over, placebo controlled, double-blind study involved 16 healthy
subjects [12 males, 4 females; 9 Caucasian, 6 African American, 1 other; mean
age= 32 14 years; body mass index=26.4 5.0 ranging from 19.1 to 36.8kg/m2].
Each
subject reported to the Inpatient Unit on two occasions one week apart. After
an
overnight fast, subjects had an IV line placed and baseline bloods samples
were drawn
at -30, -15, and 0 minutes. Subjects were then asked to swallow the capsules
of the test
supplement or an identical looking placebo.
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The administered supplement is a novel 2.9g/dose blend of 1-lysine HC1,
1-arginine HC1, oxo-proline, N-acetyl-l-cysteine, 1-glutamine, and
schizonepeta (aerial
parts) powder.
Blood was drawn at 15, 30, 60 and 90 and 120 minutes for assay. Human GH
was measured at each time point using the Siemens Immulite 2000 (infra-assay
CV
was 3.72%, inter-assay CV was 5.70%, and the detection limit for GH was
0.05ng/ml.
Mean growth hormone increased eight-fold over baseline (equivalent to 682%)
after the supplement from 0.17 at baseline to 1.33ng/m1 at 120 minutes
compared to a
mean decrease of 52% after placebo from 0.93 to 0.45ng/m1 (FIG. 1). The mean
change in GH levels from baseline to 120 minutes (GH at 120 minutes minus GH
at
0 minutes), was 1.15 (95% CI: 0.17, 2.14) ng/ml after the supplement versus -
0.48
(-1.47, 0.50) ng/ml after the placebo, demonstrating a statistically
significant
differential effect (P=0.01). After the supplement, the mean AUC for GH across
120 minutes was 20.43 (95% CI: 19.90, 20.95) ng/ml/min which was significantly
higher (P=0.04) than placebo at 19.67 (18.74, 20.59) ng/ml/min. Overall, 120
minutes
after taking the supplement, GH levels were significantly higher in both
absolute levels
and by AUC.
Mean levels of GH reached after the subcutaneous injection of 0.06 IU of HGH
in the treatment of GH deficient subjects was 0.4ng/ml, a value that was
clearly in the
range of values seen in our study with oral amino acids (Janssen YJ et al. Br
J Clin
Pharmacol 1999;47:273-278).
The present study is distinct in that it had a broad range of ages and BMI's
and
included both genders. An additional advantage of this study of the amino-acid
containing blend over previous hGH evaluations is that it contained a placebo
control
group and was randomized and double-blinded.
Example 2
The short-term effects of a single oral nutritional supplement on hGH levels
2 hours post ingestion was studied 16 healthy subjects [12 males, 4 females;
9 Caucasian, 6 African American, 1 other; mean age= 32 14 years; body mass
index=26.4 5.0 ranging from 19.1 to 36.8kg/m21. Each subject reported to the
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Inpatient Unit on two occasions one week apart. After an overnight fast,
subjects had
an W line placed and baseline bloods samples were drawn at -30, -15, and 0
minutes.
Subjects were then asked to swallow the capsules of supplement
(SER0VITAL ) or an identical looking placebo. SEROVITAL is a 2.9g/dose blend
of
1-lysine HC1, 1-arginine HCL, oxo-proline, N-acetyl-l-cysteine, 1-glutamine,
and
schizonepeta (aerial parts) powder. Blood was drawn at 15, 30, 60 and 90 and
120 minutes for assay. Human GH was measured at each time point using the
Siemens
Immulite 2000 (intra-assay CV was 3.72%, inter-assay CV was 5.70%, and the
detection limit for GH was 0.05ng/ml. The -15 and 120 minute time points were
additionally assayed for triiodothyronine (T3) as informative for mechanistic
investigations.
The mean growth hormone increased 682% after the supplement from 0.17 at
baseline to 1.33ng/m1 at 120 minutes compared to a mean decrease of 52% after
the
placebo from 0.93 to 0.45ng/m1 (FIG. 1).
The mean change in GH levels from baseline to 120 minutes (GH at
120 minutes minus GH at 0 minutes), was 1.15 (95% CI: 0.17, 2.14) ng/m1 after
the
supplement versus -0.48 (-1.47, 0.50) ng/ml after the placebo, demonstrating a
statistically significant differential effect (P=0.01). After the supplement,
the mean
AUC for GH across 120 minutes was 20.43 (95% CI: 19.90, 20.95) ng/ml/min,
which
was significantly higher (P=0.04) than placebo at 19.67 (18.74, 20.59)
ng/ml/min.
Overall, 120 minutes after taking the supplement, GH levels were significantly
higher
in absolute levels or by AUC.
As daily circadian levels of T3 naturally decrease during the morning hours,
at
which the current trial was scheduled, it was not surprising that placebo
levels between
the -15 and 120 minute time points decreased by -6.10 ng/dL (106 to 100 ng/dL,
P=0.01). In contrast, the SERoViTALER) group exhibited a deceased reduction
inT3 by
nearly one-half over the same time course, -3.3 ng/dL (101-97.3 ng/dL, NS),
which
was not a significant reduction compared to baseline, as was the reduction in
the
placebo group. These results affirm that somatostatin inhibition plays a
mechanistic
role in the ability of SER0VITALO to induce significant increases in serum GH
levels in
human subjects.
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At 120 minutes, GH concentrations were 2-fold higher in women
(2.3 1.1ng/ml, n=4) than in men (1.0 0.4 ng/ml, n= 12, although the study was
not
adequately powered for these comparisons. Nevertheless, these findings support
an
enhanced effect of the SERoVITALO supplement in women.
An eight-fold increase was observed, equivalent to 682%, in GH levels
120 minutes after a single oral supplement of SER0VITALO. The study had a
broad
range of ages and BMI's and included both genders. An additional advantage of
the
present study over previous GH evaluations is that it contained a placebo
control group
and was randomized and double-blinded.
These findings demonstrate that a specialized low-dose amino acid supplement
can significantly increase short-term GH levels. Future studies will examine
whether
such increases in GH with oral amino acid supplementation increase fat-free
mass and
strength. This indeed may be the case, since elderly subjects administered
oral GH
secretagogues for 6 and 12 months have sustained increases in lean body mass
and
improved physical function.
The absolute magnitudes of these results are somewhat difficult to directly
correlate among past studies, as commercial GH assays use different antibodies
to
target specific GH epitopes. Therefore, different antibodies and assays are
less likely
to recognize some specific isoforms and fragments of the GH molecule. This
results in
variability of the normal range of the GH measurements in different assays.
Indeed,
the same GH sample measured using different assays can vary 2-3 fold, limiting
the
ability to compare actual GH levels across studies. Nevertheless, the mean
levels of
GH reached after the subcutaneous injection of 0.06 IU of HGH in the treatment
of GH
deficient subjects was 0.4ng/ml, a value that was clearly in the range of
values seen in
our study with oral amino acids.
Findings obtained from a randomized, blinded, placebo-controlled study
strengthen the evidence that oral administration of amino acids, when
compounded
properly, can increase GH serum levels, wherein SERDVITALO administration
showed
an 8-fold, equivalent to a 682% increase in GH levels 120 minutes after a
single oral
dose. In addition, we elucidate some mechanistic details for these significant
GH
increases as through somatostatin inhibition, supported by our results on the
120 minute results on T3 levels in the same subjects.
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Example 3
To test the effect of the nutritional supplement on endurance and fat
metabolism, a double-blind clinical study was conducted involving 12 healthy
subjects
[7 males, 5 females; mean age = 31 6 years; body mass index= 25.7 3.8
ranging
from 20.3 to 32.2 kg/m2]. Each subject reported to the Fitness Testing
Facility (PEAK,
University of Utah College of Health) after an overnight fast. Upon arrival
each
subjects underwent standard measurements of weight, height, body fat percent
(Bod
Pod), and resting metabolic rate (RMR, indirect calorimerty). Daily calorie
expenditure
was estimated based on the additive evaluations of measured RMR, estimated
Lifestyle
and Activity (defined as the number of calories burned performing daily
activities
including working, playing eating, etc.), and estimated Exercise (defined as
an estimate
of the number of calories burned during exercise based on daily activity
level).
Following the baseline measurements, subjects then consumed a standard
breakfast
(Egg McMuffin, 300 Calories; 12g fat; 29g carbohydrates; 18g protein).
Subjects
rested for a further 45 min to reach a post-absorptive state, then underwent a
Maximal
Aerobic Fitness Test of graded exercise, completed on a treadmill. Subjects'
oxygen
uptake was measured using a metabolic cart, and V02max was quantified.
Subjects were then provided a two week supply of a novel supplement
StRoVITALO (2.9g/dose blend of 1-lysine HC1, 1-arginine HCl, oxo-proline,
N-acetyl-l-cysteine, 1-glutamine, and schizonepeta (aerial parts) powder). The
novel
SERDVITALO blend has been shown previously to increase serum human growth
hormone hGH levels by 8 times (equivalent to 682%) 120 minutes after a single
dose
in healthy male and female volunteers. In this study, subjects were instructed
to
consume one dose of the supplement on an empty stomach, two hours after dinner
prior to bedtime, every night for the two-week study duration. Following the
final
dose, each subject returned to the PEAK Fitness Testing Facility, University
of Utah
College of Health after an overnight fast (without having consumed their last
dose of
the supplement since the previous night). Upon arrival each subjects underwent
the
identical test protocols as the baseline test day. The data from the two
measurement
days were then analyzed. Consistent with our priori hypothesis that the
supplement
would increase improve endurance parameters with its ability to increase in
hGH
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levels, the decision was made to reject the null only if the data supported
the one
directional alternative consistent with a favorable response to the
supplement.
Statistical significance was assumed for P<0.05.
Mean V02max increased by 6% from 44.9 8.1 at baseline to 47.7
9.2mL/kg/min (3.69 0.96 to 3.91 1.02L/min), demonstrating a statistically
significant differential effect compared to baseline (P=0.02). After the
period of
supplementation with SERoViTALO, the mean RMR increased by 2.7% from 1687
330 to 1733 288kcaUday with a statistical trend towards significance
compared to
baseline (P=0.165). Estimated daily calorie expenditure also increased by 2.7%
from
1687 330 to 1733 288kca1/day with trend towards significance (P=0.166).
After two weeks of supplementation with the supplement SER0VITALO, (taken
on an empty stomach, two hours after dinner prior to bedtime, every night),
both RMR
and estimated daily calorie expenditure tended to increase, evidencing the
potential of
the supplement to impart long-term fat burning effects. Additionally,
endurance as
measured by VO2max in the post-absorptive state significantly improved with a
measured 6% increase. Overall, the SERoViTALO supplement was shown to increase
parameters of endurance, energy, and vitality.
While embodiments of the present invention have been described herein for
purposes of illustration, many modifications and changes will become apparent
to
those skilled in the art. Accordingly, the appended claims are intended to
encompass
all such modifications and changes as fall within the true spirit and scope of
this
invention
