A double blind and randomized study was performed at the Shri C. B. Patel Research Center for Chemistry and Biological Sciences in Mumbai , India . The subjects included 60 obese male and female volunteers aged 25- 45 with a body mass index (BMI) between 28 and 40 and/or body fat concentration above 30 percent in males and 40 percent in females. Participants were either given 250 mg of Forslean® (standardized to 10 percent forskolin) approximately 30 minutes before meals twice daily or a matching placebo.
Volunteers who received Forslean® lost an average of 3.81 pounds or 2.3% of their total body weight, while the placebo group gained an average of less than one half pound or 0.29% of their total body weight. Additionally, volunteers who received the placebo gained 0.32 % body fat, while individuals receiving ForsLean® lost 0.87 % body fat which was replaced by lean body mass. It was observed that the levels of all three thyroid hormones remained within normal range in both Forslean® and placebo treated groups after 12 weeks of the regimen.
Those volunteers receiving Forslean® showed a significant rise in the serum concentrations of HDL at the end of the study, while triglyceride, total cholesterol, LDL and VLDL levels remained unchanged in this group, as compared to baseline and placebo group levels. There was no significant change in the diastolic and systolic blood pressure in both Forslean® and placebo treated groups.