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

Introduction

Methods 

Study design

Investigational product

Randomization and blinding

Subjects

Study procedure

Monitoring and quality control

Statistics

Results

Discussion

Conclusion

Acknowledgement

Author contributions

Introduction

GenF20 Plus is a dietary supplement designed to increase HGH levels in individuals who are HGH deficient, a condition that affects muscle growth and endurance. HGH, a peptide hormone secreted by the pituitary gland, plays a crucial role in growth, memory, and metabolic processes. As we age, HGH secretion declines, leading to a decrease in plasma levels of insulin-like growth factor-1 (IGF-1). Studies suggest that patients with low levels of HGH can function more cognitively when substituted with HGH, promoting restful sleep, enhanced memory, and overall quality of life. GenF20 Plus offers a safe and palatable substitute for exogenous HGH and IGF-1 administration, reducing side effects and providing a promising alternative for improving muscle development.

This study's goal was to evaluate GenF20 Plus's ability to raise IGF-1 levels and the impact that had on memory, libido, energy levels, and sleep quality.

Methods 

The study was carried out in accordance with the Declaration of Helsinki and the standards of good clinical research practice after being reviewed and approved by the Independent Ethics Committee - Aditya, Ahmedabad, Gujarat, India. Before beginning any study-related procedure, all individuals provided voluntary, signed informed consent.

Study design

The study utilized a double-blind, placebo-controlled methodology. During the screening visit, the subjects' eligibility for the recruiting criteria was evaluated. At Day 0, the subjects were randomized in a ratio of 1:1 to receive either GenF20 Plus pills and liquid or a placebo tablet and liquid. The follow-up visits took place on Days 28, 56, and 84, four weeks apart.

Investigational product

GenF20 Plus is a dietary supplement containing pills 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. It is taken orally with water and sublingually, with placebo pills made of carboxymethyl cellulose and berry-flavored distilled water.

Randomization and blinding

The research involved a randomization chart created using Stats Direct v 2.7.8 statistical software. Patients were randomly assigned to receive either GenF20 Plus or a placebo on Day 0 based on the next available number. Both tablets and placebo were housed in identical bottles with the same size, weight, thickness, and color. At each visit, research drugs were given in pre-labeled, identical cartons. Labeling and masking were completed at the manufacturing facility under quality assurance staff supervision. The blinding codes were verified during each monitoring visit and kept in site master files in sealed, tamper-evident envelopes.

Subjects

From July 2011 to January 2012, a study was conducted in India, assessing potential participants for a study on the effects of exercise on memory, libido, energy levels, and sleep quality. The participants were men and women aged 35-65 with a BMI between 18.5-29.9 kg/m2 and at least one of the age-related conditions. The study excluded subjects with uncontrolled diabetes, hypertension, hypothyroidism, hepatic or renal impairment, acromegaly, significant cardiovascular comorbidities, severe neurological or psychiatric disorders, or those taking medications for these conditions. Additionally, subjects who had recently participated in a clinical trial, were hypersensitive or allergic to the investigational product, or had started an exercise or diet plan were excluded.

Study procedure

Before randomization, subjects underwent a screening visit to assess their suitability for the study. Laboratory parameters were evaluated, and patients with exclusion criteria were screened out. An electrocardiogram and urine pregnancy test were conducted. Eligible individuals were randomly assigned and followed up with physical examinations, mood scores, and body fat analysis. The intervention's effectiveness was assessed based on participants' overall health improvement, with a rating of good, fair, or poor.

Monitoring and quality control

Metropolis Healthcare Pvt Ltd in Mumbai conducted routine monitoring checks and independent audit visits to ensure accurate data and protocol adherence. The researcher explained study protocols to participants and kept records of dispensed and returned investigational products at each visit. Serum IGF-1 levels and other laboratory biochemical tests were assessed.

Statistics

The study examined the safety of GenF20 Plus, a drug for treating a variety of ages. ANOVA was used to examine changes in IGF-1 readings between two groups, with the GenF20 Plus group being divided into two subgroups based on age. The mean ages for the GenF20 Plus and placebo groups were 40.57 and 40, respectively, with median ages 38 and 39. The study also categorized the subjects into two groups based on age, with the GenF20 Plus group being under 40 and the placebo group being above 40. The safety of the drug was also assessed by comparing adverse events and changes in vital signs, hematological, and biochemistry parameters.

Results

Deposition of subjects

High TSH levels, BMI, and urine tests were conducted on 98 participants, with 28 failing the screening. High HbA1c levels, low platelet counts, and high BMI were the main causes of screening failures. Other factors included aberrant leukocyte count, high serum creatinine, and calcium oxalate crystals in urine.

Seven out of 70 respondents withdrew from the study due to reluctance to participate in lab tests, while 61 patients completed the research.

Baseline characteristics

Table 1 shows no significant difference in demographics, BMI, IGF-1 levels, or complaints duration between the two study groups at baseline, indicating successful randomization.

 

Serum IGF-1 levels

Table 2 reveals no significant increase in serum IGF-1 levels between treatment groups, indicating that the increase was not statistically significant.

IGF-1 readings increased from Day 0 to Day 84 in four groups, but not statistically significant. ANCOVA showed significant differences in mean serum IGF-1 levels at Day 0 for GenF20 Plus and placebo groups. Statistically significant changes were observed in people under 40.

 

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

On Day 84, both GenF20 Plus and placebo groups showed a slight decrease in body weight, body mass, and body fat percentage, but no significant difference was observed.

Memory, libido, energy levels, and quality of sleep

Both GenF20 Plus and placebo groups showed improvement in energy levels, sleep quality, and memory from Day 0 to Day 84, with significant differences between the two groups.

 

Global assessment by subjects

 

 

The study found that 67% of GenF20 Plus and 60% of placebo participants found the overall improvement satisfactory, but this was not statistically significant.

 

Safety

The research involved twelve adverse events, with seven in the GenF20 Plus group and five in the placebo group. Ten of these were gastrointestinal, with eight cases of hyperacidity and two cases of abdominal discomfort. Headaches and skin rashes near the eyes were the other two occurrences. The research products were deemed "probably related" or "not related" to every adverse occurrence. Blood pressure, temperature, and pulse rate did not alter clinically or statistically significant. A group of 52 participants with complete laboratory data examined for changes in laboratory measures. No statistically significant differences were found between the two groups, except for an increase in neutrophil percentage in the GenF20 Plus group and a decrease in serum creatinine levels in the placebo group. This alteration had no clinically meaningful effects.

Discussion

The study aimed to investigate the potential benefits of GenF20 Plus in promoting growth hormone secretion and reducing the effects of growth hormone decline in subjects over the age of 40. The hypothesis was that GenF20 Plus would encourage the anterior pituitary gland to produce HGH, which, when released into the bloodstream, would encourage the liver to produce IGF-1, the main mediator of HGH's effects. The study found that serum IGF-1 levels in the GenF20 Plus group grew greater than those in the placebo group, but this rise was not statistically significant. The study also found no significant difference in BMI, WC, body fat, and lean body mass between the GenF20 Plus and placebo groups at the conclusion of the 12-week treatment period. Memory, energy levels, and sleep quality all improved statistically significantly in both groups. All subjects tolerated GenF20 Plus well, and 12 adverse events were documented. However, the longer these deficits persist, the longer it will take for any agent to return to normalcy or experience advantages. Long-term use of GenF20 Plus should raise HGH and IGF-1 levels and show improvements in various aspects of quality of life.

Conclusion

This was the first investigation on GenF20 Plus's impact on IGF-1 levels. Serum IGF-1 levels may rise with continued GenF20 Plus use in a clinically meaningful manner. In conclusion, GenF20 Plus is definitely worth further investigation as a possible agent to improve quality of life in the overweight and aging population, even though it may not have produced the predicted efficacy results in this trial.

Acknowledgement

We thank Aliya Shakeel for her assistance with the study's concept and design as well as Arun Nanivadekar for his leadership and unwavering support. We also thank DM Contact Management for providing financial support for the study as well as Pravin Supe, Rahul Patil, and Shivram Bhonagiri for their assistance in gathering patient data. On the website http://www.genf20-plus.com/GenF20Plus-Study-19-7-2012.pdf you can get the full Clinical Study Report.

Author contributions

Navneet Sonawane worked on the study's conceptualization and design, data analysis and interpretation, and paper writing. Vinayak Kale and Suhas Erande gathered patient data and read the paper. Jayesh Chaudhary contributed to the study's planning and offered advice on the manuscript. The study as a whole is the responsibility of all authors, who also critically examined and approved the article.