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OpenTrials
Completed

NCT Number: NCT02492464

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

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)

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

S. Orsola-Malpighi University Hospital

Bologna, BO, 40138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

red yeast rice

Dietary Supplement

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

Placebo

Dietary Supplement

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. 12 hour fasting LDL-cholesterolemia change from the baseline to the end of treatment period

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

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

Acronym: Monasc10_15

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 8, 2015
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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