A Randomized, Double-Blind, Multicenter, Phase III Clinical

Study to Investigate the Efficacy and Safety of Forslean® in

Increasing Lean Body Mass.

Dr.M.S.Kamath, Dr.M.V.Nagaraj, Dr. K.J.Malagi

Kasturba Medical College, Manipal University, Manipal – 576104, Karnataka, India.

(ayurveda.kmc@manipal.edu)

ABSTRACT
Objective: This study examined the effect of Forslean® (extract of Coleus forskohlii
root standardized for 10 percent forskolin) on lean body mass in otherwise health
obese ( BMI 28 kg/m2) subjects.

Research Methods and Procedure: Fifty subjects (Forslean® , n = 25; placebo, n

= 25) were studied in a randomized, double-blind, placebo-controlled study for 12
weeks.

Results: Forslean® was shown to elicit favorable changes in lean body mass by
significantly increasing lean body mass as determined by calculating percentage of
body fat ( using Tanita bioelectrical impedance monitor ) to total body weight, from
which percentage of lean body mass was calculated which equals to hundred minus % of
body fat to total body weight compared with the placebo group (p 0.05).
Additionally, Forslean® administration resulted in decrease in weight, fat content. Both
systolic and diastolic blood pressures reduced similarly in the two treatment groups and
the difference between the two groups was not significant. Forslean did not affect any of
the laboratory parameters adversely. In fact it had a trend towards causing an
improvement in lipid profile as compared to placebo.

Discussion: Oral ingestion of Forslean® (250 mg of 10% forskolin extract twice a

day) for a 12-week period was shown to favorably alter lean body mass, body
weight, body fat percentage, without affecting any other physiological or laboratory
parameters studied. The results indicate that Forslean® is a possible therapeutic
agent for the management and treatment of overweight and obesity.