The Effect of Hypocol® on Lipids in Subjects With Mild Hypercholesterolemia and Mildly Elevated Blood Glucose
The purpose of this study is to determine to what degree Hypocol® (Red Yeast Rice) may lower low density lipoprotein (LDL)-cholesterol in a European population. The effect of Red Yeast Rice on fasting blood glucose and inflammatory markers will also be investigated.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Single-Centre, Randomised Double-Blind Placebo-Controlled Study to Measure the Effect of Hypocol® on Lipids in Subjects With Mild Hypercholesterolemia and Mildly Elevated Blood Glucose|
- The effect of HypoCol on lipids in subjects with mild hypercholesterolemia.
- The effect of HypoCol on fasting glucose, glycosylated hemoglobin (HbA1c) and high sensitive CRP.
|Study Start Date:||March 2005|
|Study Completion Date:||June 2006|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
Clinical end-point trials have demonstrated that lowering cholesterol levels with statins reduces the incidence of cardiovascular events and mortality. Subgroup analyses of the large clinical studies, the West of Scotland Coronary Prevention (WOSCOP) and Cholesterol and Recurrent Events (CARE), have suggested that the beneficial effects of statins may extend to mechanisms beyond cholesterol reduction. A variety of mechanisms accounting for these effects have been suggested. Among these, the anti-inflammatory activity is particularly attractive because inflammation is considered an early step in the development of atherosclerosis. Thus, statin therapy has been shown to lower high-sensitivity C-reactive protein (CRP), a plasma marker of inflammation, in hypercholesterolemic patients. Furthermore, statins may possess anti-inflammatory properties by their ability to reduce the number of inflammatory cells in atherosclerotic plaques. Red Yeast Rice contains Lovastatin and lowers LDL-cholesterol. However, it is not known to what degree Red Yeast Rice may lower LDL-cholesterol in a European population. Some reports have suggested an effect of Red Yeast Rice on fasting blood glucose by an unknown mechanism.
|Oslo, Norway, 0027|
|Principal Investigator:||Kjetil Retterstøl, Dr. med||Oslo University Hospital|