Study design and Methodology

• ForsLean® was evaluated in a 12 week open field study in overweight volunteers, 1 man and 13 women; average weight 74.7 ± 11.98 kg, average BMI 29.9 ± 4.31 and average body fat 38.2 ± 4.87%.
  
  
• ForsLean® was administered in a dose of 125 mg twice a day. Total daily intake of ForsLean® was calculated as 25 mg of diterpene forskohlin.
  
  
• Each patient was examined in the physician's office, and body composition measurements were taken with infrared analyzer Futurex6200 on day 0, 1st month, 2nd month and 3rd month.
  
  

Study results

Efficacy:

• Total body weight showed a tendency to decrease from an average 74.7 kg at the onset of the study to 73.5 kg on the 3 rd month (p<0.05).
  
  
• Body mass index improved from initial average value 29.9 to 29.4 (p<0.05) at the conclusion of the study.
  
  
• The body fat was decreased from initial average value 38.2% to 37.1% (p<0.01) at the conclusion of the study.
  
  
• Lean body mass was preserved during the course of 12 week ForsLean® administration (average 45.8 kg vs. 45.9 kg).

Safety:
The 12 week regimen with 25 mg of forskohlin per day did not significantly change blood pressure parameters, i.e. average systolic blood pressure 135.7 mmHg vs. 128 mmHg; average diastolic blood pressure 85.3 mmHg vs. 83.6 mmHg.

Conclusion:

This 12 week open field study of ForsLean® on 14 overweight Japanese subjects indicates its usefulness in weight loss management with no apparent subjective and objective side effects of the regimen