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

University of Bologna40 enrolled

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Atherosclerosis

Interventions

Red yeast riceDIETARY_SUPPLEMENT

1 capsule to be taken before to sleep, each day, for 6 months

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

S. Orsola-Malpighi University Hospital

Bologna, BO, Italy

Outcomes

Primary Outcomes

Flow mediated dilation (FMD) change from the baseline to the end of treatment period

Time frame: 6 months

Secondary Outcomes

12 hour fasting LDL-cholesterolemia change from the baseline to the end of treatment period

Time frame: 6 months

Data from ClinicalTrials.gov

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