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

Atherosclerosis Clinical Trial

— Monasc10_15  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492464
• Other study ID #: Monasc10_15
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2024
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

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

Locations

Country	Name	City	State
Italy	S. Orsola-Malpighi University Hospital	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Cicero AF, Morbini M, Rosticci M, D''Addato S, Grandi E, Borghi C. Middle-Term Dietary Supplementation with Red Yeast Rice Plus Coenzyme Q10 Improves Lipid Pattern, Endothelial Reactivity and Arterial Stiffness in Moderately Hypercholesterolemic Subjects. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow mediated dilation (FMD) change from the baseline to the end of treatment period		6 months
Secondary	12 hour fasting LDL-cholesterolemia change from the baseline to the end of treatment period		6 months