Embargoed Until 4/19/98, 9 a.m. Pacific time
Contact:
Lisa Tush 310/444-1308
Whitney Ertel 415/984-2281 415/677-4194
RESULTS OF THE FIRST U.S. CLINICAL STUDY ON THE CHOLESTEROL-LOWERING EFFECTS OF CHINESE RED YEAST RICE DIETARY SUPPLEMENT RELEASED
-- Cholestin Shown to Reduce Cholesterol by 18% on Average --
SAN FRANCISCO, April 19, 1998 -- Today at the Experimental Biology Ã98 conference, Dr. David Heber, director of the UCLA Center for Human Nutrition, presented the findings of the first U.S. clinical study on the cholesterol-lowering effects of Cholestin, a dietary supplement made of Chinese red yeast rice. The study shows that Cholestin significantly reduces cholesterol levels in healthy adults.
Cholestin extract has been shown in numerous studies in China to help people with moderately elevated cholesterol (200-239 mg/dL) achieve and maintain healthier levels. Dr. HeberÃs findings reaffirm these earlier results.
"This is an entirely new approach to effectively lowering cholesterol levels naturally that is more potent than other remedies such as garlic," said Dr. Heber. "For the 58 million Americans who have cholesterol between 200-240 mg/dL, a level at which drugs are not indicated, a significant risk reduction can be achieved with this new dietary supplement that is based on an ancient Chinese food."
Red yeast rice (monascus purpureus went) is a dietary staple in many Asian countries (14-55 grams per serving) and has been used for thousands of years to make rice wine, as a spice and food preservative and for medicinal purposes. The double-blind, placebo-controlled randomized study of 83 healthy subjects (46 men, 37 women) was conducted to determine the cholesterol-lowering effects of a proprietary preparation of this yeast, marketed as Cholestin.
According to the current guidelines for cholesterol management, subjects with a cholesterol level between 200-239 mg/dL after applying a healthy diet and exercise regimen are candidates for this new approach. Subjects in this UCLA study all had undesirably high cholesterol levels, but not high enough to be considered diseased or candidates for drug therapy.
Subjects were treated with 2.4 grams per day or a placebo rice capsule. Both groups were instructed to maintain a 30 percent fat diet (<10% saturated fat, <300 mg cholesterol).
Results On average, Cholesterol decreased in the treated group from 254 + 36 to 208 + 31 mg/dL by eight weeks with no change in the control group. There were no significant differences in diets between the two groups as determined by food frequency questionnaires at the beginning of the study and at eight weeks. There were no adverse effects on liver or kidney function from this natural food product.
"This is a very important study that will help millions of individuals lower their cholesterol and improve their health," said cardiologist James Rippe, M.D. "Given the prevalence of cardiovascular problems in the United States, Cholestin represents an important breakthrough as a safe, effective and affordable means of achieving healthier cholesterol levels."
Open Clinical Trial Also Supports Findings Currently, an open clinical study of Cholestin in 142 subjects in the U.S. is underway with expected completion in May 1998. So far, 118 subjects have completed the study. The data analyzed at this point show a significant decline (13 percent average) in cholesterol at day 28 and day 56 when compared to day 2 of the study. All subjects had moderately elevated cholesterol levels at the beginning of the study (between 200-240 mg/dL).
Total Cholesterol (mean + SD *p<0.05)
Baseline 8 weeks 12 weeks Placebo: 255±29 254±36 250±36
Cholestin: 254±36 208±31* 210±31*
Triglycerides (mean ± SD *p<0.05)
Baseline 8 weeks 12 weeks Placebo: 143±46 142±52 146±47
Cholestin: 133±48 118±41* 124±44*
LDL Cholesterol (mean ± SD *p<0.05)
Baseline 8 weeks 12 weeks Placebo: 180±30 179±32 175±33
Cholestin: 173±27 134±27* 135±27*
HDL Cholesterol (mean ± SD *p<0.05)
Baseline 8 weeks 12 weeks Placebo: 46±10 46±10 46±11
Cholestin: 50±13 50±13 50±14
Dietary Assessment
Total Calories
Baseline 8 weeks 12 weeks Placebo: 1780±920 1670±690 1600±720
Cholestin: 1580±510 1540±530 1340±490*
Total Fat (g/day)
Baseline 8 weeks 12 weeks Placebo: 66±46 60±40 59±37
Cholestin: 55±26 54±26 44±21*#
Saturated Fat (g/day)
Baseline 8 weeks 12 weeks Placebo: 23±18 20±15 20±14
Cholestin: 19±10 19±11 15±8*
Cholesterol (mg/day) Baseline 8 weeks 12 weeks Placebo: 241±194 214±146 224±173
Cholestin: 202±161 190±116 154±70
* indicates p<.05 compared to baseline # indicates p<.05 compared to control
UCLA - University of California Los Angeles
# # #
RSS