Maintaining lean body mass is essential for good health. The percentage of lean body mass to fat not only determines the body’s aesthetic look, but more importantly, it determines a person’s physical fitness, health status and risk for morbidity (disease) and premature mortality (death). For example, abdominal fat is a significant risk factor for cardiovascular disease. Exercise that results in increased lean body mass may have a positive impact on long-term cardiovascular risk and life span. Including ForsLeanâ as part of an exercise program may further enhance the health benefits that come from increasing lean body mass.

	Effects of ForsLeanâ on body weight, body fat and lean body mass.
	Effects of ForsLean® on blood pressure and pulse rate.

 Sabinsa Corporation conducted 2 preliminary, clinical studies that evaluated the effect of ForsLean® on the body mass composition of overweight individuals. In the first study ForsLean® was orally administered to 4 overweight female volunteers for 12 weeks. Each volunteer received one capsule, which contained 250 mg of C. forskohlii extract (equivalent to 25 mg forskolin), twice daily. Each participant was informed about healthy eating and the benefits of regular exercise, and they were seen by a physician at the inception of the study and after 4, 8, and 12 weeks. The results showed that mean lean body mass significantly increased by 7.2 pounds from week 0 to week 12. Although not significant, percent body fat was reduced by 2.9% from week 0 to 12. No significant differences were observed in blood biochemistry or vital signs (e.g. pulse rate, systolic blood pressure values, and appetite and energy levels).

In the second clinical study, 6 overweight female volunteers received the ForsLean® formula twice daily (equivalent to 50 mg forskolin per day) for 8 weeks. Physical activity, vital signs, and body weight and body mass parameters were monitored during the course of the experiment.

During the eight week trial, the mean values for body weight and fat content significantly decreased, whereas lean body mass significantly increased compared to baseline values (Figure 1). The regimen did not adversely affect the systolic/diastolic blood pressure nor the pulse rate. In fact, a trend towards lower systolic/diastolic pressure was observed during the study (Figure 2).

The 50 mg forskolin per day dosage administered in the two preliminary, clinical studies, did not cause any untoward or adverse side effects in the patients. As a follow-up to these two preliminary studies, two additional clinical studies using ForsLean® are currently underway in the U.S. and Japan.

ForsLean® acts by a simpler, yet a different mechanism of action than ephedrine (a known weight loss supplement). As a result, some of side effects (e.g. cardiovascular etc...) experienced with ephedrine are not observed with forskolin. A detailed comparison of ForsLean® and ephedrine may be assessed on our product website, www.forslean.com.

Because Sabinsa Corporation discovered the promotion of lean body mass, fat loss, and the weight loss properties of forskolin, the U.S. Patent and Trademark office granted U.S. Patent #5,804,596 (September 8, 1998) exclusively to Sabinsa. U.S. Patent #5,804,596 is defined as "…a method of preparing a forskolin composition…and use of forskolin for promoting lean body mass and treating mood disorders". Although the patent includes forskolin compositions ranging from 1 to 40%, the most preferred composition contains 10% forskolin. ForsLean® is the only Coleus forskohlii preparation supported by a patent for its weight management benefits.

Companies or individuals using any Coleus forskohlii preparation other than ForsLean® in their respective product formulations, which suggest, imply or represent their products to promote lean body mass, fat loss and weight loss would be infringing on Sabinsa’s use patent for forskolin.

ForsLean® is now available to dietary supplement manufacturers because Sabinsa’s exclusive licensing agreement with a leading dietary supplement manufacturer has recently expired. Now Sabinsa offers interested manufacturers a new non-exclusive trademark and patent licensing agreement through our Preferred Customer Program. This agreement grants the customer the right to use the ForsLean® trademark and logo, patent claims and number, research data, advertising slogans, and other ForsLean®-related information, which are proprietary to Sabinsa, by agreeing to the provisions set forth in the agreement. The specifics of the ForsLean® Trademark & Patent Licensing Agreement can be obtained by contacting Sabinsa’s customer service departments in New Jersey (732-777-1111) or Utah (801-465-8400).

References

1. Bruneton, J. (1995) Coleus forskohlii in Pharmacognosy, Phytochemistry, Medicinal Plants. Lavoisier Publishing Co. (France), 521.
   
   
2. de Souza, N. (1991) Coleus forskohlii Briq- The Indian plant source for forskolin. Recent Advances in Medicinal, Aromatic & Spice Crops. (ed. S.P. Raychaudhuri) Today and Tomorrow’s Printers & Publishers (India), vol. I, 83-91.
   
   
3. Ammon, H. and Müller, A. (1985) Planta Medica 6, 473-477.
   
   
4. Shah, V. and Kalakoti, B. "Development of Coleus forskohlii as a medicinal crop." Proceedings of the International Conference on Domestication and Commercialization of Non-Timber Forest Products in Agroforestry Systems. Hosted by ICRAF, held in Nairobi, Kenya from Feb. 19-23, 1996.
   
   
5. ]Tandon, J. et al. (1977) Ind. J. Chem. 15B, 880-883.
   
   
6. Gabetta, B. et al. (1989) Phytochemistry 28, 859-862.
   
   
7. Rupp, R. (1995) Forskolin: Its chemical, biological and medical potential. Proc. Of the International Symposium. Hoechst India Ltd.
   
   
8. Palou, A. et al. Int. J. Biochem. Cell. Bio. 30, 7-11.