Study Review

Objective of study

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.

Study design

Double-blind placebo-controlled design. Subjects assessed for the recruitment criteria during screening visit and then randomized in the ratio 1:1 at Day 0 to receive either GenF20 Plus or placebo. The follow-up visits at an interval of 4 weeks each.

Randomization and blinding

A master randomization chart was created for the study using Stats Direct software. Subjects were randomly assigned to receive GenF20 Plus or a placebo on Day 0. Both the liquids and the pills had the same shape, weight, thickness, and colour. Medication was given to each participant in pre-labelled cartons and masked at the manufacturing facility. Blinding codes were kept up to date in site master files and verified during research monitor visits.

Subjects

Patients between the ages of 35 and 65 who had age-related symptoms such diminished memory, libido, low energy, or poor sleep quality were evaluated for the study. Participants were given the opportunity to participate if they provided written informed consent, adhered to study protocols, and kept up their present lifestyle habits without changing them. Uncontrolled diabetes, high blood pressure, hypothyroidism, hepatic or renal impairment, acromegaly, cardiovascular comorbidities, and incapacitating neurological or psychiatric illnesses, women who were pregnant, nursing, taking oral contraceptives, oestrogen supplements, or corticosteroids, those who had recognised diseases that were estrogen-sensitive, subjects who had recently participated in a clinical trial or who had an allergy or hypersensitivity, heavy smokers and recurrent drinkers were in the exclusion criteria. 

Monitoring and quality control

To guarantee data quality and procedure compliance, each location underwent routine monitoring and audit visits. The researcher kept track of experimental product dispensations and returns while educating patients about the study's protocols. Serum IGF-1 levels and other biochemical laboratory tests were assessed at Metropolis Healthcare Pvt Ltd in Mumbai, India.

Statistics

In order to find a statistically significant difference between the two groups, this exploratory clinical trial on GenF20 Plus used an arbitrary sample size of 60 completed participants, with 30 in each group. Microsoft Excel 2007 and Epi Info 3.5.1 were utilised in the study's statistical testing and effectiveness evaluations. Between the two groups, the mean changes in baseline traits, vital signs, laboratory haematological tests, lean body mass, WC, BMI, body fat percentage, memory, and libido were compared. Age was taken into account while calculating IGF-1 readings, and baseline variations were taken into account using one-way analysis of covariance (ANCOVA). Using the Pearson's chi-square test, a global assessment was made, and safety was assessed by contrasting adverse occurrences with variations in vital, haematological, and biochemical markers.

Results

Disposition of subjects: There were 28 screening failures out of the 98 individuals in the research. The remaining 70 were randomly assigned to groups that received GenF20 Plus or a placebo. High HbA1c, aberrant TSH, low platelet count, and high BMI were the main causes of failures. Eight participants declined to take part. Other causes included aberrant leukocyte count, increased serum creatinine, and calcium oxalate crystals.61 people finished the GenF20 Plus and placebo trials; seven withdrew from the research because they did not want to undertake testing.

Baseline characteristic

Table 1 shows no significant differences in demographics, BMI, IGF-1 levels, or complaints between study groups at baseline, indicating randomization effectiveness.\

Serum IGF levels

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 not statistically significant (P>0.05) when compared across the groups.

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

There was a reduction seen in WC, BMI, and body fat percentage 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.

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.