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Effect of GenF20 Plus on serum IG F-1 levels in healthy adults: A randomized controlled study

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  • Vedic Lifesciences

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Background: Aging is related to a reduction of growth hormones, resulting in physiological derailment and affects overall wellbeing. GenF20 Plus is a dietary supplement postulated to naturally stimulate the secretion of human growth hormone (HGH) through the anterior pituitary. This study sought to evaluate the effect of GenF20 Plus in enhancing the levels of insulin-like growth factor-1 (IGF-1), which is a marker of HGH levels. Methods: Seventy subjects aged 35–65 years visiting outpatient departments at five study centers across India, presenting with at least two of the following age-related complaints: decreased memory, decreased libido, low energy levels, or poor quality of sleep were randomly assigned to either GenF20 Plus (n=35) or placebo (n=35) for a period of 12 weeks (84 days). Randomization was carried out using computerized software. The primary outcome measure was serum IGF-1 levels. Changes in waist circumference, body mass index, body fat percentage, lean muscle mass, and scores for memory, libido, energy levels, and quality of sleep were also assessed. Trial registration: CTRI/2011/06/001784. Results: Sixty-one subjects completed the study as per protocol and were analyzed. The mean increase (mean ± standard deviation) in IGF-1 levels at day 84 in the GenF20 Plus group was 13.46±36.12 ng/mL and in the placebo group was 6.35±36.56 ng/mL, which was not statistically significantly different (P>0.05) when compared across the groups. In the ≥40 years subgroup, the mean increase in IGF-1 in the GenF20 Plus group (14.59±40.08 ng/mL) was not statistically significantly different when compared to the placebo group (3.17±16.09 ng/mL) using analysis of variance (ANOVA; P>0.05). However, when this change was analyzed using analysis of covariance (ANCOVA) considering baseline values as the covariates, it was found to be statistically significantly different (GenF20 Plus: 22.69±40.62 ng/mL, placebo: -4.31±16.79 ng/mL; P<0.05). The changes in IGF-1 values in the <40 years subgroup were not found to be statistically significant. No statistically significant difference over placebo was seen for the other variables. Conclusion: GenF20 Plus increased serum IGF-1 levels in subjects ≥40 years of age who physiologically have reduced IGF-1 levels. However, significant changes in other parameters were not seen, probably due to the short duration of treatment. Further studies with longer treatment duration and large sample size are warranted to understand the clinical benefits of GenF20 Plus, especially in adults above 40 years of age.
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ORIGINAL RESEARCH
open access to scientific and medical research
Open Access Full Text Article
http://dx.doi.org/10.2147/OAJCT.S75969
Effect of GenF20 Plus on serum IGF-1 levels in
healthy adults: a randomized controlled study
Navneet Sonawane1
Vinayak Kale2
Suhas Erande3
Jayesh Chaudhary1
1Vedic Lifesciences Pvt Ltd, Mumbai,
India; 2Lokmanya Hospital, Pune, India;
3Akshay Hospital, Pune, India
Correspondence: Navneet Sonawane
Vedic Lifesciences Pvt Ltd, 203, Morya
Landmark I, Off New Link Road, Andheri
(West), Mumbai, Maharashtra, India
Tel +91 22 4217 2319
Email navneet_sonawane@yahoo.com
Background: Aging is related to a reduction of growth hormones, resulting in physiological
derailment and affects overall wellbeing. GenF20 Plus is a dietary supplement postulated to
naturally stimulate the secretion of human growth hormone (HGH) through the anterior pituitary.
This study sought to evaluate the effect of GenF20 Plus in enhancing the levels of insulin-like
growth factor-1 (IGF-1), which is a marker of HGH levels.
Methods: Seventy subjects aged 35–65 years visiting outpatient departments at five study
centers across India, presenting with at least two of the following age-related complaints:
decreased memory, decreased libido, low energy levels, or poor quality of sleep were randomly
assigned to either GenF20 Plus (n=35) or placebo (n=35) for a period of 12 weeks (84 days).
Randomization was carried out using computerized software. The primary outcome measure
was serum IGF-1 levels. Changes in waist circumference, body mass index, body fat percent-
age, lean muscle mass, and scores for memory, libido, energy levels, and quality of sleep were
also assessed.
Trial registration: CTRI/2011/06/001784.
Results: Sixty-one subjects completed the study as per protocol and were analyzed. The mean
increase (mean ± standard deviation) in IGF-1 levels at day 84 in the GenF20 Plus group was
13.46±36.12 ng/mL and in the placebo group was 6.35±36.56 ng/mL, which was not statistically
significantly different (P.0.05) when compared across the groups. In the $40 years subgroup,
the mean increase in IGF-1 in the GenF20 Plus group (14.59±40.08 ng/mL) was not statistically
significantly different when compared to the placebo group (3.17±16.09 ng/mL) using analysis
of variance (ANOVA; P.0.05). However, when this change was analyzed using analysis of
covariance (ANCOVA) considering baseline values as the covariates, it was found to be statisti-
cally significantly different (GenF20 Plus: 22.69±40.62 ng/mL, placebo: -4.31±16.79 ng/mL;
P,0.05). The changes in IGF-1 values in the ,40 years subgroup were not found to be sta-
tistically significant. No statistically significant difference over placebo was seen for the other
variables.
Conclusion: GenF20 Plus increased serum IGF-1 levels in subjects $40 years of age who
physiologically have reduced IGF-1 levels. However, significant changes in other parameters
were not seen, probably due to the short duration of treatment. Further studies with longer
treatment duration and large sample size are warranted to understand the clinical benefits of
GenF20 Plus, especially in adults above 40 years of age.
Keywords: IGF-1, herbal supplement, human growth hormone, HGH, aging
Introduction
Aging is a phenomenon related to a series of catabolic processes resulting in decreased
function and structural integrity of several physiological systems. These changes in
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Sonawane et al
the aging phenotype are correlated with a decline in growth
hormone secretion and a resulting decrease in plasma levels of
its anabolic mediator, insulin-like growth factor-1 (IGF-1).1,2
Human growth hormone (HGH) is a naturally occurring
peptide hormone secreted by the pituitary gland.3 It is secreted
in a pulsatile fashion, generally following a circadian rhythm.
HGH has many varied roles throughout life, from growth
itself, including the turnover of muscle, bone, and collagen,
to the regulation of selective aspects of metabolic function,
including increased fat metabolism and the maintenance of a
healthier body composition in later life.4,5 Secretion of growth
hormone decreases with increasing age.6 There is a physi-
ological decline in HGH and IGF-1 levels as age increases,
resulting in disturbed sleep cycles and adversely affecting the
memory of an individual.7,8 Studies have shown improvement
in cognitive functioning in HGH-deficient patients by HGH
substitution.9 Thus, restoring HGH levels may stimulate sound
sleep and improve memory and the overall quality of life.
The current available therapy is targeted for HGH
replacement only in HGH-deficient individuals, but not
for healthy individuals or age-related physiological decline
of HGH. HGH and IGF-1 are also used as performance-
enhancing agents, to increase muscle mass and exercise
endurance.10 Given its potentially adverse effects like car-
cinogenic activity,11 administration of exogenous HGH and
IGF-1 is not a safe method. The growing abuse of HGH
for muscle building by athletes and body builders and its
related medicolegal issues also necessitates finding a safe
and acceptable alternative. Many herbs and amino acids
are known to combat aging, boost bodily functions, improve
physical stamina, increase lean muscle mass, improve libido,
memory, and quality of sleep.12–14 GenF20 Plus is a dietary
supplement postulated to naturally stimulate the secretion
of HGH through the anterior pituitary. It intends to provide
a solution to improve IGF-1 levels and in turn, HGH levels
without any adverse effects.
The objective of this study was to assess the efficacy
of GenF20 Plus in increasing the levels of IGF-1 and its
related effects on memory, libido, energy levels, and quality
of sleep.
Methods
The study was reviewed and approved by the Independent
Ethics Committee Aditya, Ahmedabad, Gujarat, India;
and conducted according to the principles of good clinical
research practice and the Declaration of Helsinki. Voluntary,
written informed consent was obtained from all subjects prior
to initiation of any study-related procedure.
Study design
A double-blind placebo-controlled design was chosen for
the study. The subjects were assessed for the recruitment
criteria during the screening visit and then randomized in
the ratio 1:1 at Day 0 to receive either GenF20 Plus tablets
and liquid or placebo tablets and liquid. The follow-up
visits were at an interval of 4 weeks each (Day 28, Day 56,
and Day 84).
Investigational products
GenF20 Plus is a dietary supplement consisting of tablets con-
taining L-glutamine, L-arginine HCl, L-glycine, L-tyrosine,
Tribulus terrestris extract, L-lysine HCl, astragalus root,
colostrum powder, deer velvet antler powder, gamma-amino
butyric acid (GABA), L-isoleucine, anterior pituitary powder,
phosphatidylcholine, L-valine, L-ornithine, glucose-tolerance
factor (GTF), and chromium, and liquid containing alpha
glycerylphosphorylcholine (GPC), GABA, Mucuna pruriens,
moomiyo extract, ornithine alpha ketoglutarate, L-glutamine,
L-arginine, L-lysine, L-valine, L- isoleucine, L-tyrosine,
and glycine with a palatable berry flavor. Matching placebo
tablets were made up of carboxymethyl cellulose tablets and
liquid was made up of berry-flavored distilled water with
sodium saccharin and sucralose.
The subjects were asked to take two tablets orally with
water and 2 mL of liquid sublingually before meals in the
morning and evening.
Randomization and blinding
The master randomization chart with blocks of four was
generated using statistical software (Stats Direct v 2.7.8;
Stats Direct Ltd, Altrincham, UK). At Day 0, subjects were
randomized to receive either GenF20 Plus or placebo by the
study coordinator based on the next available number as per
the randomization chart. The tablets of GenF20 Plus and
placebo were identical with respect to size, average weight,
thickness, and color and packed in identical bottles. GenF20
Plus and the placebo liquid were identical in terms of color,
flavor, and viscosity and were packed in identical plastic
amber-colored bottles.
Each subject was issued study medications in pre-labeled
identical cartons (containing a bottle of 124 tablets and three
bottles of liquid) at each visit. The labeling and masking
was done at the manufacturing unit, under the supervision
of quality assurance personnel. The blinding codes were
maintained in the site master files in sealed, tamper-evident
envelopes and were checked by the study monitor during
each monitoring visit.
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GenF20 Plus on serum IGF-1 levels in healthy adults
Subjects
Potential subjects were screened from patients attending
outpatient departments at five study centers across India from
July 2011 to January 2012.
Male and female subjects aged 35–65 years with body
mass index (BMI) between 18.5–29.9 kg/m2 having any two
of the following age-related conditions: decreased memory,
decreased libido, low energy levels, or poor quality of sleep,
with grade 1 or 2 on a five-point Likert scale (1: poor, 2: fair,
3: good, 4: very good, 5: excellent) for at least 1 month but
not for more than 6 months were offered participation in
the study. Other inclusion criteria were willingness to give
written informed consent and abide with study procedures,
come for follow-up visits, and continue current lifestyle
practices with no modifications (in diet and exercise) dur-
ing the study period. Women who were willing to practice
suitable contraception (except oral contraceptives) during
the study were recruited.
The exclusion criteria were subjects with uncontrolled
diabetes, hypertension, hypothyroidism and hyperthyroid-
ism, hepatic or renal impairment, acromegaly, significant
cardiovascular comorbidities, and debilitating neurological or
psychiatric disorders including seizure disorders, depression,
and drugs used in these conditions. Pregnant and lactating
women, women on oral contraceptives, estrogen supplements,
or corticosteroids, who had known cases of estrogen-sensitive
disorders such as breast cancer, uterine cancer, ovarian can-
cer, endometriosis, and uterine fibroids were also excluded.
Subjects with hypersensitivity or allergy to one or more of
the ingredients of the investigational product, allergy to milk
and milk products, or those who had recently (,1 month)
participated in a clinical trial were excluded. Heavy smokers
(.10 cigarettes per day) and chronic alcoholics were also
excluded. Subjects who had taken any drugs or supplements
in the preceding 1 month for decreasing body fat, increasing
libido and energy levels, and improving quality of sleep and
memory, or those who had started an exercise and/or diet regi-
men within 30 days of the screening visit were excluded.
Study procedures
The subjects were called for a screening visit 5 days before
randomization to assess their eligibility for the study. Blood
and urine samples were collected to assess laboratory
parameters (complete blood count [CBC], urine routine,
glycated hemoglobin [HbA1c], serum glutamate pyruvate
transaminase [SGPT], serum creatinine, triiodothyronine
[T3], tetraiodothyronine [T4], thyroid-stimulating hormone
[TSH]) and screen out patients with related exclusion criteria.
An electrocardiogram (ECG) was undertaken and urine preg-
nancy test was performed to rule out pregnancy.
The eligible subjects were randomized at Day 0 and called
for follow-up visits on Day 28, Day 56, and Day 84. At each
visit, complete physical examination was undertaken and
waist circumference (WC) was recorded. Also, subjects were
asked to rate their feelings or responses for the parameters of
memory, libido, energy levels, and quality of sleep on a scale
of 1–5 (1: poor, 2: fair, 3: good, 4: very good, 5: excellent).
BMI, body fat percentage, and lean body mass were measured
using Omron body fat analyzer HBF-200. Blood samples were
collected after an overnight fast of 10–12 hours for assessment
of serum IGF-1 levels at Day 0 and Day 84.
At Day 84, blood and urine assessments were performed
to assess the safety profile and ECG was recorded. Global
assessment of efficacy by subject was rated as good, fair,
and poor based on their perception of their improvement in
overall health.
Monitoring and quality control
Regular monitoring visits and independent audit visits were
carried out at each site to ensure data quality and compli-
ance to protocol. The investigator informed the subjects of
the study procedures and their obligations and responsibilities
during the study. At each visit, the record of dispensed and
returned investigational product was maintained in order to
ensure that the subject was taking the investigational product
properly throughout the treatment duration.
All the laboratory biochemical tests including serum
IGF-1 levels were evaluated at a central laboratory – Metrop-
olis Healthcare Pvt Ltd, Mumbai, India.
Statistics
Since this was the first exploratory clinical study on GenF20
Plus, no statistical method was used for sample size calculation.
An arbitrarily chosen sample size of 60 completed subjects,
with 30 in each group, was planned in the study to detect
a statistical difference between GenF20 Plus and placebo.
Considering a withdrawal and dropout rate of 25%, we planned
to recruit a maximum of 80 subjects in the study.
All statistical tests were applied with 95% confidence
intervals and performed using Epi Info 3.5.1 and Microsoft
Excel 2007. The efficacy analyses were conducted on the per
protocol population. Mean changes in baseline characteris-
tics in terms of vital parameters, laboratory hematological
tests, BMI, body fat percentage, lean body mass, WC, and
parameters of memory, libido, energy levels, and quality of
sleep from Day 0 to Day 84 were compared across the two
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Sonawane et al
Screened
N=98
Randomized
N=70
Placebo
N=35
GenF20 plus
N=35
Completed
N=31
Completed
N=30
Withdrawn N=3
Lost to follow-up N=2
Withdrawn N=4
Figure 1 Disposition of subjects.
Table 1 Demographic data and baseline characteristics
Baseline characteristics GenF20 Plus
(n=35)
Placebo
(n=35)
Age (years)
Mean (SD) 40.57 (6.01) 42.00 (7.21)
Sex
Male N (%)
Female N (%)
18 (51.43)
17 (48.57)
13 (37.14)
22 (62.86)
Low energy N (%) 35 (100) 31 (88.57)
Decreased memory N (%) 18 (51.43) 13 (37.14)
Decreased libido N (%) 9 (25.71) 10 (28.57)
Poor quality of sleep N (%) 27 (77.14) 32 (91.43)
Serum IGF-1 levels (ng/mL)
Mean (SD) 134.52 (44.17) 123.47 (44.59)
BMI (kg/m2)
Mean (SD) 24.59 (3.15) 25.47 (2.94)
BMI category
Normal N (%)
Overweight N (%)
Obese N (%)
19 (54.29)
16 (45.71)
0 (0)
13 (37.14)
21 (60)
1 (2.86)
Duration of complaints (days)
Mean (SD) 89.57 (39.16) 83.51 (37.22)
Abbreviations: BMI, body mass index; IGF-1, insulin-like growth factor-1; SD, standard
deviation.
groups using analysis of variance (ANOVA). Changes in
IGF-1 values from Day 0 to Day 84 were compared across the
two groups using ANOVA. A subgroup analysis by ANOVA
was done post hoc, with two subgroups based on the subjects’
age; group 1 with subjects aged $40 years and group 2 with
subjects aged ,40 years. As the mean ages for the GenF20
Plus and placebo groups were 40.57 and 40 years, respec-
tively, and median 38 and 39 years, respectively, 40 years was
selected as the cut-off for the subgroups. One-way analysis
of covariance (ANCOVA) was then performed to adjust the
baseline variations for IGF-1.
For global assessment, good and fair was clubbed
together as a satisfactory response and poor was denoted as
an unsatisfactory response and was evaluated using Pearson’s
chi-square test.
Safety was evaluated by comparing the number of
adverse events in both the treatment groups and assessing
changes in vital parameters, hematology, and biochemistry
parameters.
Results
Disposition of subjects
The details of the subjects recruited and completing the study
are presented in Figure 1. Ninety-eight subjects were screened
for the study; out of which 28 were screening failures. The
remaining 70 subjects were randomized and allocated to
either the GenF20 Plus (n=35) or placebo (n=35) groups.
The major reasons for screening failures included high
HbA1c levels (n=7), abnormal TSH levels (n=6), low
platelet count (n=2), and high BMI (n=2). Eight subjects
were unwilling to participate in the study. Other reasons for
screening failure were presence of calcium oxalate crystals in
urine (n=1), elevated serum creatinine (n=1), and abnormal
leukocyte count (n=1).
Out of the 70 randomized subjects, seven subjects
were withdrawn from the study because they were unwill-
ing to undergo laboratory tests and two subjects were lost
to follow-up. A total of 61 subjects completed the study;
GenF20 Plus (n=31) and placebo (n=30).
Baseline characteristics
The demographics and key baseline characteristics for the
subjects recruited in the study are presented in Table 1. There
was no statistically significant difference between the two
groups at baseline in terms of demographics, BMI, IGF-1
levels, and duration of complaints; indicating effectiveness
of randomization.
Serum IGF-1 levels
The changes in serum IGF-1 levels are presented in Table 2.
There was an increase seen in IGF-1 values from baseline
to the end of treatment in both the groups; however, it
failed to reach statistical significance. This change was also
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GenF20 Plus on serum IGF-1 levels in healthy adults
Table 2 Changes in serum insulin-like growth factor (ng/mL)
Group GenF20 Plus Placebo
All
subjects
Day 0 Day 84 Change Day 0 Day 84 Change
N=31 N=30
Mean
(ng/mL)
134.52 147.98 13.46 123.47 129.81 6.35
SD 44.17 45.19 36.12 44.59 52.13 36.56
Min 56.14 51.1 -46 40.8 60.5 -43
Max 224 277 86 243 247 115.1
Abbreviation: SD, standard deviation.
Table 3 Changes in serum insulin-like growth factor for subgroups (ng/mL)
GenF20 Plus Placebo
Day 0 Day 84 Observed
change
Adjusted
change
Day 0 Day 84 Observed
change
Adjusted
change
Age $40 years N=13 N=13
Mean (ng/mL) 130.61 145.20 14.59 22.69a96.67 99.84 3.17 -4.31
SD 47.08 36.55 40.08 40.62 29.54 27.30 16.09 16.79
Min 61.8 89.8 -46 40.8 65.8 -25.5
Max 217 206 86 114 160 42.8
Age ,40 years N=18 N=17
Mean (ng/mL) 138.13 149.84 12.71 12.06 143.96 152.73 8.78 9.46
SD 42.31 51.09 34.41 37.41 43.82 55.48 47.05 47.92
Min 56.4 51.1 -30 74.3 60.5 -43
Max 224 277 84 243 247 115.1
Note: aStatistically signicant using ANCOVA.
Abbreviations: ANCOVA, analysis of covariance; SD, standard deviation.
not statistically significant (P.0.05) when compared across
the groups.
In the subgroup analyses (Table 3), there was an increase
seen in the IGF-1 values from Day 0 to Day 84 in the four
groups which was not statistically significant using ANOVA.
Mean serum IGF-1 levels at Day 0 in the subgroups was
found to be significantly different for the GenF20 Plus and
placebo groups; hence, the mean change in IGF-1 values was
analyzed by ANCOVA, taking the IGF-1 values at Day 0 as
the covariate. The change was found to be statistically signifi-
cant (P,0.05) for the $40 years subgroup when compared
across the treatment groups and not statistically significant
(P.0.05) for the ,40 years age group.
Waist circumference, BMI, body fat
percentage, and lean body mass
There was a reduction seen in WC, BMI, and body fat per-
centage in both GenF20 Plus and placebo groups at Day 84;
however, it was not statistically significant (P.0.05) when
compared within groups and across groups. The lean body
mass increased slightly in both the groups but did not reach
statistical significance (Table 4).
Memory, libido, energy levels,
and quality of sleep
There was improvement in all the variables from baseline to the
end of treatment in both GenF20 Plus and placebo groups. The
change was statistically significant for energy levels and sleep
quality in both the GenF20 Plus and placebo groups and for
memory in the placebo group from Day 0 to Day 84, but was
not statistically significant across the two groups (Table 5).
Global assessment by subjects
Twenty-one (67.74%) and 18 (60%) subjects rated the overall
improvement as satisfactory and ten (32.26%) and 12 (40%)
rated it as unsatisfactory in the GenF20 Plus and placebo
groups, respectively. However, this was not statistically sig-
nificant (P,0.05) as shown by Pearson’s chi-square test.
Safety
Twelve adverse events occurred in the entire study (seven in the
GenF20 Plus group andve in the placebo group); ten of which
were of the gastrointestinal system (eight hyperacidity cases and
two cases with pain in the abdomen). The other two events were
headache and skin eruptions just below the eyes. Except for the
two pain in the abdomen events, which were of moderate severity,
the events were mild in severity. All adverse events were judged
as “probably related” or “not related” to the study products. All
events were completely resolved before the end of the study.
There were no clinically or statistically significant changes
seen in pulse rate, blood pressure, and temperature.
Changes in laboratory measurements were analyzed in
a subset of 52 subjects from per protocol population for
whom complete laboratory data was available. When com-
pared for changes from screening to Day 84, no statistically
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Sonawane et al
significant changes were observed in the hematology and
biochemical laboratory variables within each group and
between the two groups except for an increase in neutrophil
percentage in the GenF20 Plus group (57.56%±7.47% to
62.04%±6.69%; mean ± standard deviation [SD]) and a
reduction in serum creatinine levels in the placebo group
(0.86±0.19 to 0.77±0.15 mg/dL; mean ± SD). However, this
change was not clinically significant.
Discussion
Serum IGF-1 and HGH levels are known to decrease with
increasing age and are related to the physiological changes
in lean body mass,15 sleep,7 memory,8 and energy levels16
that are due to increasing age. Replenishing depleting serum
IGF-1 and HGH levels is postulated to provide the benefits of
younger age and relieve the signs and symptoms of growth
hormone decline. A clinical study by Rudman et al has shown
beneficial effects of HGH administration in a group of elderly
healthy men with low plasma IGF-I values, but no underlying
pituitary pathology.17 Sattler et al also demonstrated that HGH
supplementation increased lean mass, muscle strength, and
aerobic endurance with significant reductions in whole-body
and trunk fat.18 These studies support the hypothesis that
increased levels of IGF-1 and HGH will stimulate lipolysis
and cause a reduction in body fat. An improvement in cogni-
tive functioning in HGH-deficient patients by HGH substitu-
tion has also been shown in a few studies.19,20
The present study was undertaken with a postulated role
of GenF20 Plus in stimulating the anterior pituitary gland
to secrete HGH, which when released into the blood stream,
stimulates the liver to produce IGF-1, the primary mediator
of the effects of HGH. GenF20 Plus contains essential amino
acids and other ingredients that are known to stimulate the
production and secretion of HGH from the anterior pituitary
gland. Amino acids are known to improve HGH levels.21
Arwert et al showed that a supplement containing glycine,
glutamine, and niacin increased serum HGH levels by 70%
relative to placebo and individual increases in IGF-1 were
associated with improved memory and vigor.22
In the present study, from baseline to the end of treatment,
serum IGF-1 levels increased more in the GenF20 Plus group
than in the placebo group. However, this increase was neither
clinically nor statistically significant. In the subgroup analysis
based on age using ANCOVA, in the $40 years subgroup,
adjusted percentage change in IGF-1 was 28.57% in the
GenF20 Plus group as compared to -0.55% in the placebo
group, a difference that was statistically significant (P,0.05).
In the ,40 years subgroup, there was no marked change in
either of the treatment groups. This could be attributed to
the sustained inherent mechanism of the body to be able to
secrete normal levels of serum IGF-1 levels below 40 years
of age. This analysis enables us to postulate that GenF20 Plus
is able to stimulate secretion of HGH and IGF-1; this change
is noticeably observed in those above 40 years of age.
Table 5 Effect on memory, libido, energy levels, and quality of sleep
Variables Day 0 Day 84 Change Day 0 Day 84 Change
Memory
N=41
GenF20 Plus (N=22) Placebo (N=19)
2.04 (0.90) 2.76 (1.16) 0.41 (0.80) 2.10 (0.81) 2.77 (1.15)a0.31 (0.48)
Libido
N=33
GenF20 Plus (N=18) Placebo (N=15)
2.50 (0.78) 3.00 (1.14) 0.17 (0.71) 2.47 (0.99) 3.05 (1.35) 0.20 (0.41)
Energy levels
N=59
GenF20 Plus (N=31) Placebo (N=28)
1.16 (0.37) 2.39 (0.80)a1.22 (0.80) 1.21 (0.50) 2.14 (0.93)a0.93 (0.86)
Quality of sleep
N=56
GenF20 Plus (N=27) Placebo (N=29)
1.52 (0.70) 2.55 (0.93)a1.04 (0.85) 1.24 (0.63) 2.10 (1.08)a0.86 (1.02)
Notes: Values are expressed as mean (SD); astatistically signicant by ANOVA.
Abbreviations: ANOVA, analysis of variance; SD, standard deviation.
Table 4 Changes in waist circumference, BMI, body fat percentage, and lean body mass
GenF20 Plus (N=31) Placebo (N=30)
Day 0 Day 84 Change Day 0 Day 84 Change
Waist circumference (cm) 36.26 (5.04) 35.96 (4.85) -0.30 (0.81) 36.12 (5.19) 35.87 (5.01) -0.25 (0.76)
BMI (kg/m2) 25.78 (8.27) 25.67 (8.23) -0.11 (0.63) 25.43 (2.88) 25.23 (2.95) -0.20 (0.79)
Body fat percentage (%) 26.55 (10.97) 25.66 (11.65) -0.89 (1.85) 28.16 (7.06) 27.75 (7.35) -0.41 (1.34)
Lean body mass (kg) 47.31 (6.92) 47.59 (6.99) 0.27 (0.88) 47.41 (7.59) 47.53 (7.79) 0.12 (0.99)
Note: Values are expressed as mean (SD).
Abbreviations: BMI, body mass index; SD, standard deviation.
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GenF20 Plus on serum IGF-1 levels in healthy adults
At the end of 12 weeks of treatment, BMI, WC, body
fat, and lean body mass did not show a significant change
from baseline to the end of treatment in both the GenF20
Plus and placebo groups. There was a statistically significant
improvement in memory, energy levels, and quality of sleep
from baseline to the end of treatment in both the groups
(P,0.05), but it failed to achieve statistical significance when
compared between the two groups. No statistically significant
difference was seen between the two groups for global assess-
ment by subjects when assessed by Pearson’s chi-square test.
GenF20 Plus was well-tolerated by all the subjects. There
were a total of 12 adverse events reported (seven in the active
group and five in the placebo group) during the study. They
were mild, not related to the study products, and were suc-
cessfully resolved. No serious adverse events occurred in the
study. The present study has not shown improvement in all the
parameters assessed, possibly due to the short duration of the
study. It failed to show considerable reduction in BMI, WC,
or body fat in both the GenF20 Plus and placebo groups. The
parameters of sleep, memory, libido, and energy levels also
did not show substantial improvement as compared to placebo.
Improvement in all of the above parameters is difficult to
attain in a short duration of 12 weeks. The longer the duration
of these impairments, the longer the time required to attain
normalcy or perceivable benefits by any agent. The fact that
serum IGF-1 levels increased with statistical significance in
the $40 years subgroup is an indication that prolonged usage
of GenF20 Plus may show improvement in other parameters
as well. Prolonged consumption of GenF20 Plus should
increase HGH and IGF-1 levels and manifest improvement in
the quality of life parameters. GenF20 Plus may be required
to be consumed for an extended period of time to show any
considerable improvement in weight and body fat.
Conclusion
This was the first study done on GenF20 Plus to assess its
effects on IGF-1 levels. Prolonged usage of GenF20 Plus
may be able to show a clinically significant increase in serum
IGF-1 levels. In summary, GenF20 Plus may not have deliv-
ered the projected efficacy results in this study, but is certainly
worthy of further exploration as a potential agent to improve
quality of life in the overweight and aging population.
Acknowledgments
We acknowledge the support provided by Aliya Shakeel in
the concept and design of the study and Arun Nanivadekar
for his guidance and incessant support. We also acknowledge
the contribution of Pravin Supe, Rahul Patil, and Shivram
Bhonagiri in the collection of patient data and the financial
support received from DM Contact Management for the study.
The complete Clinical Study Report is available at http://
www.genf20-plus.com/GenF20Plus-Study-19-7-2012.pdf?
Author contributions
Navneet Sonawane was involved with the conception and
design of the study, analysis and interpretation of data, and
drafted the manuscript. Suhas Erande and Vinayak Kale
collected patient data and reviewed the manuscript. Jayesh
Chaudhary participated in the design of the study and
provided expert comments on the manuscript. All authors
critically reviewed and approved the manuscript and are
accountable for the entire study.
Disclosure
This study was conducted by Vedic Lifesciences Ltd with
financial support from DM Contact Management. Vedic
Lifesciences Ltd is an independent research organization,
which is in no way related to DM Contact Management nor
has any financial interests in the results of the study. The
authors did not have any financial or commercial competing
interests to declare in relation to this manuscript.
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