Effect of GenF20 Plus on serum IGF-1 levels in healthy adults: a randomized controlled study

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

Number of times this article has been viewed

This article was published in the following Dove Press journal:

Open Access Journal of Clinical Trials

25 March 2015

.

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 .m

Dovepress

'. 

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

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 wasTable 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 and five 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

'

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

s

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.

References

1. Khan AS, Sane DC, Wannenburg T, Sonntag WE. Growth hormone,

insulin-like growth factor-1 and the aging cardiovascular system.

Cardiovasc Res. 2002;54(1):25–35.

2. Giovannini S, Marzetti E, Borst SE, Leeuwenburgh C. Modulation

of GH/IGF-1 axis: potential strategies to counteract sarcopenia in older

adults. Mech Ageing Dev. 2008;129(10):593–601.

3. Saugy M, Robinson N, Saudan C, Baume N, Avois L, Mangin P. Human

growth hormone doping in sports. Br J Sports Med. 2006;40 Suppl 1:

i35–i39.

4. Godfrey RJ, Madgwick Z, Whyte GP. The exercise-induced growth

hormone response in athletes. Sports Med. 2003;33(8):599–613.

5. Ho KY, Veldhuis JD, Johnson ML, et al. Fasting enhances growth

hormone secretion and amplifies the complex rhythms of growth

hormone secretion in man. J Clin Invest. 1988;81(4):968–975.

6. Juul A, Main K, Blum WF, Lindholm J, Ranke MB, Skakkebaek NE.

The ratio between serum levels of insulin like growth factor (IGF)-1

and the IGF binding proteins (IGFBP-1, 2 and 3) decreases with age

in healthy adults and it is increased in acromegalic patients. Clin

Endocrinol (Oxf). 1994;41(1):85–93.

7. Vgontzas AN, Tsigos C, Bixler EO, et al. Chronic insomnia and activity

of the stress system: a preliminary study. J Psychosom Res. 1998;45(1):

21–31.

8. Zelinski EM, Burnight KP. Sixteen-year longitudinal and time lag

changes in memory and cognition in older adults. Psychol Aging.

1997;12(3):503–513.

9. Schneider HJ, Pagotto U, Stalla GK. Central effects of the somatotropic

system. Eur J Endocrinol. 2003;149(5):377–392.

10. Velloso CP. Regulation of muscle mass by growth hormone and IGF-I.

Br J Pharmacol. 2008;154(3):557–568.

11. Tentori L, Graziani G. Doping with growth hormone/IGF-1, anabolic

steroids or erythropoietin: is there a cancer risk? Pharmacol Res. 2007;

55(5):359–369.