Effects of 10 mg Monacolins on Vascular Health: a Clinical Trial
Not Applicable
Completed
- Conditions
- Atherosclerosis
- Registration Number
- NCT02492464
- Lead Sponsor
- University of Bologna
- Brief Summary
This will be a double-blind randomized clinical trial carried out on subjects with suboptimal control of LDL-cholesterolemia, following a Mediterranean diet, and treated with a red yeast rice extract (containing 10 mg monacolin K per daily dose) or placebo, in order to evaluate the middle-term effects on vascular health evaluated by non invasive methods (Vicorder(R) apparatus)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- LDL-cholesterol between 130 and 190 mg/dL
Exclusion Criteria
- Secundary prevention for cardiovascular disease
- Type 2 diabetes
- Assumption of lipid-lowering drug or dietary supplements
- Previous intolerans to read yeast rice including dietary supplements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Flow mediated dilation (FMD) change from the baseline to the end of treatment period 6 months
- Secondary Outcome Measures
Name Time Method 12 hour fasting LDL-cholesterolemia change from the baseline to the end of treatment period 6 months
Trial Locations
- Locations (1)
S. Orsola-Malpighi University Hospital
🇮🇹Bologna, BO, Italy
S. Orsola-Malpighi University Hospital🇮🇹Bologna, BO, Italy