Study conducted by: K. Bonovich,
Bel Air, MD; H Colfer, Petokey, MI; M. Davidson, Chicago. IL;
C. Dujovne; D Fried, Providence, RI; M. Greenspan,
Sellerville, PA; S. King, Spokane, WA; R. Karlberg, Beverly
Hills, CA; C. LaForce, Raleigh, NC; M. Litt, Jacksonville
Beach, FL; JR McGhee, Ocala. FL; J. Rippe, Shrewsbury,
MA.
A traditional Chinese food and medicine,
Red Yeast Rice, was evaluated in a multicenter,
self-controlled, open-label study in 187 subjects (116 men, 71
women) with midly to moderate elevated total cholesterol (TC)
and LDL cholesterol (LDL-c). Elligible subjects were placed on
the AHA Step 1 Diet throughout the study. After 4-weeks on
this diet, Red Yeast Rice (2.4 g/day) was given for 8 weeks.
Lipid profiles were determined at week 4 (4 weeks of diet),
and at Week 8 and 12 (4 and 8 weeks of Red Yeast Rice
treatment), and at Week 14 (2 weeks after discontinuing Red
Yeast Rice).
The diet alone for 1 month had no effect on
serum cholesterol. The 8-week treatment with Red Yeast Rice
reduced; TC by 16.4%, LDL-c by 21.0%, triglycerides (TG) by
24.5%, and ratio of total: HDL cholesterol by 17.7%, and
increased HDL cholesterol (HDL-c) by 14.6%. Discontinuation of
Red Yeast Rice following the treatment led to a relatively
rapid return of serum lipids to pre-study levels at Week 14.
Product-related adverse reactions were mild and moderate in
severity.
Thirty four patients (18%) were judged to
have adverse reactions possibly or probably related to Red
Yeast Rice treatment. The reported adverse events were
headache, abdominal bloating, and gas. This multi-center
clinical trial at 12 U.S. sites confirmed that treatment with
a traditional Chinese food, Red Yeast Rice, was well tolerated
and was effective in reducing TC, LD-c, TG and ratio of
TC:HDL-c, and in increasing HDL-c in patients with
hyperlipidemia.
About the
director of the study: Dr. James Rippe, M.D., is an
internationally renowned cardiologist an a leading authority
on health, fitness and healthy weight loss.
A graduate of
Harvard Medical School, he is currently director of the Center
for Clinical and Lifestyle Research and an associate professor
of cardiology at Tufts University School of Medicine. He is
also the founder and director of the Rippe Health Assessment
at Celebration Health in Orlando, Florida.
The author of
20 books, Dr. Rippe has developed corporate fitness programs
for leading companies such as Allstate Life Insurance and The
Shimizu Corporation. Formerly the medical editor for the
Television Food Network (TVFN), he has been featured on
programs and in print media including: The Today Show, Good
Morning America, CNN, The New York Times, The Wall Street
Journal and Los Angeles Times.
