DEMONSTRATING THE CHOLESTEROL-LOWERING BENEFITS OF A NATURAL HERBAL PRODUCT: THE CHOLESTIN STORY

CLIENT: PHARMANEX (A DIVISION OF NuSkin)

CATEGORY: Dietary Supplement Company

BACKGROUND

Cholestin is a natural herbal product that has been used for thousands of years in traditional Chinese medicine as a way of "improving heart health." Preliminary studies in China suggested Cholestin may have cholesterol-lowering effects. Pharmanex introduced Cholestin to the United States market under authority granted by Congress in the Dietary Supplement and Health Education Act of 1990 (DSHEA). Pharmanex approached Rippe Lifestyle Institute to conduct definitive scientific trials utilizing Western scientific methods to validate the possible cholesterol lowering benefits of Cholestin.

RLI'S RESPONSE

RLI participated in a multi-center trial to investigate the cholesterol lowering benefits of Cholestin in pill form in individuals with mildly elevated cholesterol. Dr. Rippe served as the lead investigator for this trial, which demonstrated that Cholestin lowered LDL cholesterol and triglycerides approximately 20 percent. Subsequently, RLI served as the sole site for an intervention trial looking at the cholesterol-lowering effects of Cholestin, in the form of Cholestin Bars, combined with American Heart Association Step I Diet in adults with mildly elevated cholesterol. This trial, completed in mid-1999, showed that Cholestin Bars are just as effective as the pill form. Total cholesterol dropped on average 14 percent and LDL levels dropped on average 22 percent.

In conjunction with the two Cholestin research projects, Pharmanex decided to inaugurate the Pharmanex Institute for Cardiovascular Health and Sports Nutrition at RLI. This research institute, under Dr. Rippe's direction, not only conducts scientific research but also serves as the vehicle for articulating scientific results to both the pubic at large and the health community. Dr. Rippe is the Director of the Pharmanex Institute.

RESULTS

The research conducted at RLI helped Cholestin achieve national prominence as a natural herbal product that promotes healthy cholesterol levels. Dr. Rippe has published two abstracts, presented results at scientific meetings and conducted numerous media interviews on the results of the Cholestin Pill study. RLI research also served as a cornerstone of a successful effort on the part of Pharmanex to prevent the FDA from terminating the sale of Cholestin. Pharmanex, utilizing information generated by Dr. Rippe and RLI , obtained an injunction in Federal Court to prevent the FDA from using its regulatory power to take Cholestin off of the market. Establishment of the Pharmanex Institute for Cardiovascular Health and Sports Nutrition promotes better coordination between research efforts and articulation of findings to healthcare professionals and the public at large. The Pharmanex Institute is currently conducting two other studies for Pharmanex. The results of these two studies are expected to be released in late 2000.