Genf20 Plus: Effect on Insulin-Like Growth Factor Levels in Adults A Randomized Controlled Trial

Aging is a debilitating process that is associated with biological, social, and physiological changes. On a biological level, aging is a complex and multifactorial issue that is based on the accumulation of changes that can lead to disease and possibly death. For decades, it has been linked with a decline in the levels of growth hormone (HGH). Human growth hormone is produced by the pituitary gland and stimulates growth and regulates other bodily functions. As time progresses, the pituitary gland reduces the production of HGH. There has been evidence regarding the possible benefits of HGH administration on sleep, memory, and cognitive ability. Therefore, maintaining levels of growth hormone might be a target for a potential treatment for aging or age-related processes.

Genf20 Plus

Genf20 Plus

Although HGH therapies can improve and boost the overall quality of life this does not come without its downfalls. The misuse of HGH by individuals has stirred a lot of controversy regarding whether the benefits outweigh the risks. Athletes continue to use these hormones to boost their performance without understanding potential consequences. HGH and IGF-1 have harmful side effects such as diabetes, muscle pain, and possible increased risk of cancer.

Research has shown that the aging process is linked to a decrease in the concentration of two important hormones, growth hormone and insulin-like growth factor-1 (IGF-1). Currently, researchers have worked toward finding a safer alternative. One such example is GenF20 Plus, which is a dietary supplement that targets the levels of HGH and IGF-1. GenF20 Plus, a dietary supplement, has shown positive effects in stimulating the production of the growth hormone. A study was conducted to confirm the beneficial effects of GenF20 Plus on the levels of growth hormone and insulin-like growth factor (IGF-1). Therefore, researchers who conducted this study aimed to evaluate whether GenF20 Plus is a potential alternative and can contribute to an increase in IGF-1 serum levels and improve quality of life.

The Genf20 Plus Clinical Study Methodology

Subjects were recruited through outpatient clinics at study centers across India. To be eligible, subjects had to present with a minimum of two age-related complaints. Seventy subjects whose ages ranged between 35-65 years were eligible to partake in the study for 12 weeks. After meeting eligibility, subjects were then randomized using the software in a 1:1 ratio to either GenF20 Plus or placebo group. IGF-1 levels were measured along with weight-related outcomes and age-related complaints.

Study Design

This study is a randomized double-blinded placebo trial. The subjects were screened based on the inclusion criteria and if they meet eligibility criteria were randomized in a 1:1 ratio to either the GenF20 Plus or placebo group and were followed for 12 weeks every 4 weeks.

Genf20 Plus

GenF20 Plus is an HGH supplement that contains various amino acids. Two tablets were taken orally each day with water and liquid before meals in the morning and evening.

Randomization

At baseline, subjects were randomized in a 1:1 ratio to either the GenF20 or the placebo group by the study coordinator. Subjects were issued medications at each visit. Tablets and liquids of both groups were identical and packaged in the same fashion.

Subjects Selections

Genf20 Plus Ingredients

Genf20 Plus Ingredients

Interested subjects were screened from July 2011 to January 2012 based on the inclusion criteria to determine if they were eligible in an outpatient setting across five study centers in India.

Inclusion criteria included subjects between the ages of 35-65 years with a normal body mass index at least two age-related complaints such as memory loss, decreased sex drive, low energy levels, or lack of proper sleep for a minimum of 1 month and a maximum of 6 months.

Exclusion criteria included subjects with comorbidities, psychological, and/or neurological issues. Pregnant women and women who had cancer were excluded. Subjects with an allergy to the ingredients of GenF20 Plus, or those who had recently (<1 month) participated in a clinical trial were excluded. Heavy smokers, alcoholics, and drug users were also excluded.

Genf20 Plus Study Protocol

Screening visit for subjects occurred five days before the randomization visit to assess eligibility for the study. At the screening visit, laboratory testing (blood and urine) was performed alongside an electrocardiogram (ECG).

Physical examination was completed at each visit. In addition, subjects were asked to complete an assessment on how they felt after the intervention for the age-related conditions of memory, libido, energy levels, and quality of sleep on a scale of 1–5 (1 being poor and 5 being excellent). Serum IGF-1 levels were collected at baseline and at the end of the intervention.

At the end of the intervention, blood and urine tests were performed to compare results from the baseline. Assessment by the subject was rated as good, satisfactory, and poor based on their view regarding the improvement in their overall health.

Quality assurance

Quality control and assurance checks occurred at each of the five centers to ensure data quality and adherence to study protocol. The investigator notified the subjects of possible risks and responsibilities during the study.

Statistical Analysis

Statistical analysis was conducted using Epi Info 3.5.1 and Microsoft Excel 2007 with a p-value of lower 0.05 as being statistically significant. Changes in laboratory testing, serum levels of IGF-1, weight-related outcomes, and age-related complaints from baseline (day 0) to end of treatment (day 84) were compared between the two groups using analysis of variance (ANOVA). A comparison of subjects aged 40 and above and below 40 years of age was conducted. One-way analysis of covariance (ANCOVA) was then performed using baseline IGF-1 values as covariates.

For assessment by participants, Pearson’s chi-square test was used to evaluate their responses. Good and fair were combined to yield a satisfactory response and poor was designated as an unsatisfactory response. The number and severity of adverse events were compared in both the treatment groups.

Genf20 Plus Results

Recruitment of Subjects

Screening occurred for 98 potential participants, however, 28 participants failed screening due to multiple medical reasons. Seventy subjects were randomly assigned in a 1:1 ratio to either GenF20 Plus or placebo groups for a total of 35 participants in each group. After randomization was completed, a total of nine subjects were dropped from the study, with only 61 subjects remaining and completing the study. Of the nine, seven patients did not want to partake in laboratory testing and two subjects were lost to follow-up.

Baseline characteristics

There were no statistically significant differences in the baseline data between the two groups.

Serum IGF-1 levels

Within-group analysis of serum IGF-levels showed an increase from Day 0 to Day 84 despite not being statistically significant. A between-group analysis also showed no statistical significance.

Study participants aged 40 and above showed an increase in serum levels of IGF-1 using ANOVA albeit not statistically significant. On ANCOVA, there was a statistically significant difference in IGF-1 levels using baseline IGF-1 data as covariates. In comparison, study participants aged below 40 did not show statistically significant differences.

Weight-related outcomes

Subjects in both groups (GenF20 Plus and placebo) showed a reduction in weight-related outcomes shown in Table 4. Analysis within and between-group revealed that this reduction was not statistically significant.

Improvement in age-related complaints

Subjects in both groups (GenF20 and placebo) showed improvement in all age-related complaints (Memory, Libido, Energy Level, and Quality of Sleep) from baseline to end of treatment. Energy levels and quality of sleep in both groups were statistically significant, while the memory was only statistically significant within the placebo group but not between groups.

Assessment of Genf20 Plus by subjects

Subjects assessed the intervention at the end of the study period. From the GenF20 Plus group, 21 participants rated it as satisfactory compared to 18 subjects in the placebo group. On the other hand, ten subjects from the GenF20 Plus group and 12 from the placebo group rated it as unsatisfactory.

Genf20 Plus Side Effects

No serious events were observed in this study, but 10 mild adverse events and 2 moderate adverse events occurred. Seven side effects arose in GenF20 Plus study participants and five in the placebo study participants. However, the adverse events were resolved prior to the completion of the study period.

Implications Of Genf20 Plus Study Findings

Laboratory data were available in only 52 patients. There were no statistically significant differences in hematological and biochemical panels within and between groups. Despite no clinical significance, an elevated neutrophil percentage in the GenF20 Plus group, and a reduction in serum creatinine in the placebo group were observed.

Of the seventy subjects who participated, nine subjects did not complete the study leaving sixty-one participants. GenF20 {lus group (13.46±36.12 ng/mL) had a higher increase in serum IGF-1 levels at the end of the intervention (Day 84) compared to the placebo group (6.35±36.56 ng/mL) albeit not statistically significant. In subjects who were aged 40 and above, there was no significant increase in levels of IGF-1 between both groups with ANOVA. This was not the case with ANCOVA which showed a statistically significant difference with an IGF-1 level of 22.69±40.62 ng/mL in the GenF20 Plus group compared with -4.31±16.79 ng/mL for the placebo group. When conducting the same analysis for the cohort aged below 40 years, there was no statistical difference.

Aging is a natural gradual process that is based on changes that take place at various levels. As such, one example of such change is the decrease in two hormones, human growth hormone and insulin-like growth factor with time. It has been suggested that such a decrease can affect an individual’s wellbeing and quality of life. Previous research has demonstrated positive outcomes with the administration of HGH related to cognitive ability and muscle composition.

Prior research has shown the role of supplements containing amino acids in stimulating the production of the levels of growth hormone. Therefore, it was hypothesized that the supplement GenF20 Plus will have a similar effect in increasing the secretion of HGH from the anterior pituitary gland. The process of enhancing the production of HGH stimulates the liver to produce IGF-1.

Our study showed the important role of GenF20 Plus in increasing serum IGF-1 levels from baseline to end of treatment in both groups albeit not statistically or clinically significant. Additionally, in study participants aged 40 and above with ANCOVA, there was a statistically significant difference with a higher percentile change in IGF-1 levels among the GenF20 Plus group compared to the placebo group. For study participants below age 40, there was no statistically significant difference.

Weight-related outcomes did not show any statistically significant differences from baseline to end of treatment in both groups. Within each group, there was a statistically significant improvement for age-related complaints, but this was not observed between groups.

Given the low number of and severity of adverse events, GenF20 Plus can be considered a safe alternative method. Although GenF20 Plus did not show a statistically significant change in the study outcomes such as weight-related, cognitive functioning, and laboratory testing one should be wary of concluding that is it not effective because of the short duration of the study. Additionally, the subgroup analysis by age of those aged 40 and above provided an important stepping stone for further investigation that GenF20 Plus can potentially contribute to improving quality specifically in individuals aged 40 and above. Therefore, future studies should focus on a longer-follow up period and larger recruitment of participants to better understand the effect of GenF20 Plus in the secretion of growth hormones.

GenF20 Plus Research Concludes With Positive Findings

In a subgroup analysis of subjects aged over 40, GenF20 Plus had positive effects on levels of IGF-1 on individuals with a low baseline level of IGF-1. Given the short period of 12 weeks, it is probable that changes in other outcomes were not able to manifest. Therefore, future works should focus on recruiting a larger cohort of patients and a longer follow-up period to understand the potential effects of GenF20 Plus on the levels of growth hormones. 

Overall, this is the first study of its kind to examine the effect of GenF20 Plus on the secretion of growth hormones. Although the results were not entirely favorable it is still worthwhile to investigate GenF20 Plus as a treatment option in targeting aging processes specifically in those aged 40 years or above.

References

Arginine and ornithine supplementation increases growth hormone and insulin-like growth factor-1 serum levels after heavy-resistance exercise in strength-trained athletes

Effects of l-arginine on growth hormone and insulin-like growth factor 1

Effect of Arginine and Ornithine on GH and IGF-1 After Exercise

Study on the effect of L-Arginine on GH and IGF-1 expression

HGH Deficiency Symptoms And Latest Testing Options

HGH Side Effects: Is HGH Worth the Risks and Are There Safe Alternatives?

 

 

 

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