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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Red yeast rice

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

Group Type ACTIVE_COMPARATOR

Red yeast rice

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Red yeast rice

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No