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

Introduction

GenF20 Plus is a dietary supplement produced to naturally stimulate HGH through the anterior pituitary gland. It intends to provide a solution to improve IGF-1 levels and HGH levels. HGH (Human Growth Hormone) is a peptide hormone which is responsible for cell growth, tissue turnover, metabolic regulations, memory, quality of sleep and libido. GenF20 Plus is a solution for increasing both HGH and IGF-1 levels without any side effects.

The purpose of this study is to determine the effectiveness of GenF20 Plus on memory, quality of sleep, energy levels and libido.

Methods

The study was conducted as per the guidelines of good clinical research practice and Declaration of Helsinki followed by the approval of the Independent Ethics Committee - Aditya, Ahmedabad, Gujarat, India. All the subjects have written informed consent before continuing with any study related procedure.

Study Design

For this study, a double blind placebo-controlled design was used. Subjects were screened for recruitment criteria during screening visit and as per 1:1 ratio, they were randomized to receive either GenF20 Plus or placebo at Day 0. Within a 4 week intervals, follow-up visits were made.

Investigational products

GenF20 Plus is a dietary supplement containing L-glutamine, L-arginine HCl, L-glycine, L-tyrosine, Tribulus terrestris extract, L-lysine HCl, astragalus root, colostrum powder, deer velvet antler powder, GABA, L-isoleucine, anterior pituitary powder, and phosphate. The placebo tablets were made of berry-flavoured distilled water with sodium saccharin and sucralose. The tablets are to be taken orally with water and liquid to be taken sublingually.

Randomization and blinding

For the research, participants were randomized by Stats Direct v2.7.8. software. Subjects were to receive either GenF20 Plus or placebo bottle on Day 0, as per the next available number, in which the both GenF20 Plus and placebo were packed in identical bottles. Research drugs were provided in pre-labeled cartons, in which labelling and masking were done by the quality assuring personnel of the manufacturing unit. The blinding codes were monitored during each visit and secured in tamper-proofed envelopes.

Subjects

A study conducted in india from July 2011 to January 2012 overviewed on the affects of exercise on memory. libido, energy and sleep in individuals aged 35-65 with a BMI between 18.5 and 29kg/m^2 and atleast one age related condition. Subjects with uncontrolled diabetes, hypertension, hyperthyroidism, hepato-renal impairment, acromegaly, cardiovascular illnesses, severe neurological of psychiatric disorders and on medications for such conditions were excluded. Furthermore, individuals with allergies to the investigational product, had an exercise or diet plan or participated in another clinical trial recently were excluded.

Study procedure

Subjects suitability for the trial was assessed on a screening visit, before the randomization. Subjects with exclusion criteria were excluded from the trial. Laboratory investigations were carried as well as electrocardiogram and urine pregnancy test. Eligible subjects were randomized at Day 0 and on each follow up visit, physical examination, mood scores and body fat analysis was done. The efficacy of the process was assessed according to the participants health improvement rated by good, fair or poor.

Monitoring and quality control                                        

Regular monitoring visits and audit visits were made at each site to maintain data quality and protocol compliance. The subjects were informed of their responsibilities during the study, by the investigator. The record of dispensed and returned investigational product were carried out during the visit, guarantee that subjects were using the investigational product properly.

Laboratory biochemical tests including serum IGF-I levels were evaluated at a central laboratory - Metropolis Healthcare Pyt Ltd, Mumbai, India.

Statistics

No statistical method was used for sample size calculation since this is the first clinical study on GenF20 Plus. All statistical tests were done using Epi Info  3.5.1 and Microsoft Excel 2007 and tests were applied with 95% confidence intervals. Using ANOVA, comparison of changes in IGF-1 values from Day 0 to Day 84 were made between 2 groups. Group 1 is subjects aged ≥40 years and group 2 with subjects aged <40 years. Mean ages for GenF20 Plus and placebo groups were 40.57 and 40 years and median ages were 38 and 39 years. The safety of the drug was also determined by comparing the frequency of adverse affects in both groups.

Results    

                                                                                                                                                       disposition of subjects                                                                                                                                   98 subjects were screened for the research, in which 28 were failures. The remaining 70 subjects were randomized and grouped into GenF20 Plus (n=35) and placebo (n=35). Screening failures were mainly due to high HbA1c levels, abnormal TSH levels, low platelet count and high BMI. Presence of  calcium oxalate crystals in urine, increased serum creatinine and abnormal leukocyte count.

Total of 61 subjects completed the study GenF20 Plus (n=31) and placebo (n=30), as 7 out of 70 subjects were withdrawn from the study and 2 out of 70 were lost to follow-up.

Baseline characteristics

Table 1 states the baseline characteristics for the recruited subjects of the study. There is no statistically significant difference between the two groups at baseline in terms of demographics, BMI, IGF-1 levels, and duration of complaints, hence, indicate the efficacy of randomization.

Serum IGF-1 levels

Serum IGF-1 level changes are shown in table 2.

Although there was an increase in IGF-1 levels from baseline to end of the treatment from both groups, it failed to reach statistical significance and the change is not statistically significant (p>0.05) when comparison made among both groups.

Waist circumference, BMI, body fat percentage and lean body mass

As shown in table 4, there was a reduction in WC, BMI and body fat percentage in both GenF20 Plus and placebo groups at Day 84, although when compared within and across groups, it failed to reach statistical significance

Memory, libido, energy levels and quality of sleep

Table 5 presents that all the variables were enhanced from baseline to end of treatment in both GenF20 Plus and placebo groups. The improvement of sleep quality and energy levels were statistically significant within the groups, but not across the groups.

Global assessment by subjects

21 and 18 subjects rated the overall improvement as satisfactory and 10 and 12 rated it as unsatisfactory. Although, as shown by Pearson's chi-square test, this was not satistically significant

Safety

There 12 adverse events in this study, 10 were gastrointestinal cases, with 8 cases of hyperacidity of mild severity and 2 cases of abdominal pain of moderate severity. There was an event of skin eruption below the eye and another case of headache, both cases with mild severity. All events were completely resolved before the end of the study.

There were no clinically or statistically significant changes of pulse rate, blood pressure and temperature.

Laboratory parameters  were analyzed in 52 subjects per protocol population with complete laboratory data availability. There were no changes in haematology and biochemical values within and across each groups with the exception of neutrophilia in GenF20 Plus group and declined serum creatinine in placebo group. However, the change was not statistically significant.

Discussion                                                                                                                                                      This study highlights on the roles of GenF20 Plus in the secretion of HGH by anterior pituitary gland and its stimulation on liver to secrete IGF-1. Serum IGF-1 and HGH levels decrease with age, leading to physiological changes in lean body mass, sleep, memory, and energy levels. The regulation of these hormones provide the benefits of younger age and growth hormone declining symptoms and signs are reduced. GenF20 Plus consist of essential amino acids and other ingredients that stimulate HGH production. From baseline to the end of treatment, increase in serum IGF-1 levels is more in the Genf20 Plus group more than the placebo group. However, this increase failed to reach neither statistical nor clinical significance. There was no statistically significant increase in WC, BMI, body fat percentage and lean body mass between GenF20 Plus and placebo group. However, there was a statistically significant increase in energy levels, memory and sleep quality in both groups. All the subjects were compliant to GenF20 Plus and there were 12 adverse events. Genf20 Plus must be used for long term in order to receive significant changes in the all variables.

Conclusion 

This was the first study evaluating the effects of GenF20 Plus on IGF-1 levels. Long term use of GenF20 Plus may be able to significantly increase the serum IGF-1 levels. Further studies on GenF20 Plus as a product for the improvement of aging individual's quality of life, is recommended.

Acknowledgements                                                                                                                                      We acknowledge Aliya Shakeel for the support in the study's concept and design and Arun Nanevadekar on his guidance and support. The contribution of Pravin Supe, Rahul Patil, and Shivram Bhonagiri for contributing to collecting patient data must also be mentioned. Utmost appreciation for the financial aid of this study, DM contact management.                                                                                                    

Author contributions                                                                                                                                  

Navneet Sonawane contributed to the study’s conception and design, data analysis, interpretation, and drafting of the manuscript. Analysis of manuscript and collection of data were done by Suhas Erande and Vinayak Kale. Expert feedback was by Jayesh Chaudhay. Critical review and approval was done by the authors.

The  complete clinical report: www.genf20-plus.com/GenF20Plus-Study-19-7-2012.pdf?