Randomized Double Blind Placebo Controlled Study (India)
Study design and Methodology
- A 12 week double blind and randomized study, with 60 obese male and female volunteers, 25 – 45 years old with a Body Mass Index (BMI) between 28 – 40 and / or body fat concentration above 30% in males and 40% in females
- Subjects received either 25 mg of diterpene forskohlin twice daily in the form of ForsLean® or matching placebo.
- Body weight and total body fat measurements at 0 week, 3 weeks, 6 weeks, 9 weeks and 12 weeks.
- The thyroid function tests were performed, assessing levels of hormones T3 , T4 and TSH before and after the completion of the study.
- Blood lipid profiles were obtained initially and at the end of 12 weeks.
- Liver and Kidney function tests initially at the end of 12 weeks
- Blood glucose and insulin initially at the end of 12 weeks
- Haematological parameters initially at the end of 12 weeks
Study results
Efficacy:
- Forslean® treated volunteers shed on an average 1.73 kg from their body weight, in comparison placebo group gained 0.25 kg. These differences are statistically significant.
- During the 12 – week period of treatment volunteers treated with placebo gained 0.68% of body fat. On the other hand, the Forslean® treated group lost 0.46% of body fat. These differences are statistically significant.
- In the group of volunteers that received Forslean®, there was an increase in the LBM as compared to the placebo group where, there was a decrease in LBM. These differences are statistically significant.
- HDL cholesterol showed a statistically significant increase in volunteers treated with Forslean®. Other serum lipid profiles remained statistically unaltered in the Forslean® and Placebo treated groups.
Safety:
- It was observed that the levels of all three thyroid hormones remained within normal range in both active compound and placebo treated groups after 12 weeks of the regimen.
- Those volunteers receiving the active compound 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 changes in the diastolic and systolic blood pressure of volunteers treated with Forslean® and placebo.
- The levels of blood glucose and insulin remains unchanged in the groups which received Forslean® and Placebo.
- Liver and Kidney function test and haematological parameters did not show any changes in the group of volunteers which receive Forslean® and Placebo.
Conclusion:
Results suggest that ForsLean® reduces body weight and body fat, and helps promote lean body mass. The 12 week treatment did not produce any subjective or objective side effects in either active compound or placebo receiving groups. The active group showed increase in serum levels of HDL and significant decrease of total cholesterol/HDL ratio as compared to the control group. No untoward effects on thyroid hormones and blood lipid profile and other parameters were observed.
Reference:
1. Study conducted at C.B. Patel Research Centre for Chemistry and Biological Sciences, Mumbai. Data on file of Sami Labs Limited, Bangalore, India.
