A randomized, peer-reviewed, double-blind, clinical trial conducted by J.S. Stern et al. was performed at ASRAM, Eluru, Andhra Pradesh, India from March 2010 to July 2010. The study protocol was evaluated and approved by the ASRAM Institutional Review Board and published in the highly respected journal Obesity.
The clinical trial consisted of 60 subjects with BMI ranging between 30 – 40. Participants were randomized into a study group receiving 400mg capsules of SigmaLean and a placebo group receiving 400mg of placebo. Participants received a standard 2000 calorie diet as outlined by USDA guidelines (61% carbohydrates, 14% protein, 25% fat) and were instructed to perform 30 minutes of moderate walking 5 days/week for the duration of the trial.
After 2 weeks the SIGMALean group had reduced their body weight substantially more than placebo (average 4.1 pounds) with a significant reduction of waist size (1.66 inches) and at 8 weeks the SigmaLean group had reduced their body weight by 11.2 pounds over the placebo in addition to significant reduction in waist size circumference (4.66 inches) all with no major adverse events.
Rarely has this journal published clinical data surrounding dietary supplement ingredients. Typically only drugs and weight loss protocols are included in Obesity. For the SigmaLean blend to be covered in the Obesity Journal is a testament of its relevance, legitimacy, and efficacy.
A second double-blind peer-reviewed analysis performed by J.S. Stern et al. was published in the Journal of Medicinal Food in 2013 that took the results of the 60 participants from the above study 1 and included 40 additional participants in the same exact study design protocol as study 1.
After 2 weeks the SIGMALean group showed a significant reduction of an average of 4.4 pounds of total body weight, than placebo. At the end of the 8 week protocol SigmaLean participants significantly reduced body weight and waist and hip circumference by 11.5 pounds greater than placebo, 4.7 inches, and 2.5 inches respectively in waist and hip size vs. placebo.
The results from the 100 participants were pooled in order to achieve a greater level of statistical power (more people, more accurate). The pooled results validated the original study and lends further credibility. BioTrust Nutrition does not only have two “gold standard” clinical trials (double blind, placebo controlled) to back up the Metabo379 formula, but we have what we like to call the “Platinum Standard”. The “Platinum Standard” is when two or more studies are successfully executed with the same study protocol (the same parameters of weight, diet, exercise, supplementation, exclusions on health, etc.), and deliver statistically significant and similar results in each.