Effects of 10 mg Monacolins on Vascular Health: a Clinical Trial (Monasc10_15)

University of Bologna

Status: Completed

Conditions: Atherosclerosis

Treatments: Dietary Supplement: Red yeast rice; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02492464

Monasc10_15

Details and patient eligibility

About

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)

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Red yeast rice

Active Comparator group

Description:

Red yeast rice extract 200 mg, containing 10 mg monacolin K per daily dose, 1 capsule per day, per 6 months

Treatment:

Dietary Supplement: Red yeast rice

Placebo

Placebo Comparator group

Description:

Placebo 200 mg (neutral fibre), 1 capsule per day, per 6 months

Treatment:

Dietary Supplement: Placebo