US and Japanese Clinical Trials of Sabinsa’s ForsLean® for Weight Management Underway

June 11, 2001

Two new studies have been undertaken to further explore the safety and efficacy of ForsLean®, Sabinsa’s patented lean body mass promoting and weight loss product, one in the US and the other in Japan. ForsLean®, Sabinsa’s patented brand of Coleus forskholii root extract is being studied by Dr. Tsuguyoshi Asano, a prominent Tokyo based Japanese physician who specializes in Internal medicine and bariatrics. The 12 week study protocol includes 20 overweight, but otherwise healthy, men and women who have a body mass index (BMI) check. ForsLean® will be administered twice a day in the form of a two piece hard shell capsule. Each capsule contains 250 mg of the extract standardized for 10% forskolin. Each participant will receive a physical examination, and their blood biochemistry and body composition will be analyzed at the inception and after 4, 8 and 12 weeks of the study. ForsLean® has been cleared for nutritional use by the Japanese FDA. The US study has recently commenced at the University of Memphis, Exercise & Sports Nutrition Laboratory. Twenty mildly obese female subjects between the ages of 18 to 40 have been recruited to participate in this study.

The study was designed as a double blind, placebo controlled investigation of ForsLean® versus similarly matched placebo for 12 weeks. After baseline testing, subjects will be randomly assigned to ingest 2 capsules a day containing ForsLean® or the placebo (one capsule in the morning and one in the evening, half an hour before a meal). Each active capsule contains 250 mg of ForsLean®.

Analysis for this trail includes the overall assessment of selected parameters, blood pressure, body composition and individual serological and hematological profiles. Subjective questionnaires to determine the subjects’ perception of the treatment and quality of life/lifestyle aspects will also be administered. Further markers pertaining to blood chemistries will be obtained in order to evaluate potential toxicity.

Prior to these two studies, both and LD50 analysis and AMES test were performed by independent laboratories in the US confirming the safe use of ForsLean®.

Sabinsa Corporation is an application oriented manufacturing and marketing company which manufactures and supplies Phytonutrients, Ayurvedic herbal extracts and specialty fine chemicals used for its customers and products, and the scientific credentials of its key technical staff.

ForsLean® is a registered trademark of Sabinsa Corporation.

US Patent #5,804,596 with other international patents pending.