Effects of 10 mg Monacolins on Vascular Health: a Clinical Trial

Overview

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)

Full Title of Study: “Double-blind, Randomized Clinical Trial on the Middle-term Effect of the Red Yeast Rice Intake on Endothelial Function and Arterial Stiffness in Subjects With Suboptimal LDL-cholesterol Level in the Context of the Mediterranean Diet”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Triple (Participant, Care Provider, Investigator)
• Study Primary Completion Date: June 2015

Interventions

• Dietary Supplement: Red yeast rice
  • 1 capsule to be taken before to sleep, each day, for 6 months
• Dietary Supplement: Placebo

Arms, Groups and Cohorts

• Active Comparator: Red yeast rice
  • Red yeast rice extract 200 mg, containing 10 mg monacolin K per daily dose, 1 capsule per day, per 6 months
• Placebo Comparator: Placebo
  • Placebo 200 mg (neutral fibre), 1 capsule per day, per 6 months

Clinical Trial Outcome Measures

Primary Measures

• Flow mediated dilation (FMD) change from the baseline to the end of treatment period
  • Time Frame: 6 months

Secondary Measures

• 12 hour fasting LDL-cholesterolemia change from the baseline to the end of treatment period
  • Time Frame: 6 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University of Bologna
• Provider of Information About this Clinical Study
  • Principal Investigator: Claudio Borghi, Professor Claudio Borghi – University of Bologna