Red Rice Yeast in Low-density Lipoprotein (LDL) Lowering: an Efficacy Study

Phase 2

• Conditions: Dyslipidemias; LDL Hyperlipoproteinemia
• Interventions: Drug: Red Rice Yeast Extract; Drug: Statin

• Registration Number: NCT03607383
• Lead Sponsor: Saint-Joseph University

Brief Summary

Red yeast rice is a source of active compounds in reducing LDL levels with practically no side effects. Molval Fort is a natural product available in the Lebanese market with a combination of red yeast rice extracts, EPA/DHA and coenzyme Q10.

The investigators are conducting this study to explore the effect of red yest rice extracts based product on LDL and its side effects in a sample of primary care Lebanese patients.

Detailed Description

Red yeast rice is a source of active compounds in reducing LDL levels with practically no side effects. Studies performed on American and Chinese populations have shown positive results. These studies need confirmation in different populations. Molval Fort is a natural product available in the Lebanese market with a combination of red yeast rice extracts, EPA/DHA and coenzyme Q10. The investigators are conducting this study to explore the effect of red yest rice extracts based product on LDL and its side effects in a sample of primary care Lebanese patients.

Study Timeline

• Study Start: 2018-02-07
• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-07-29
• Study First Posted: 2018-07-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-04
• Last Update Posted: 2019-10-08
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult patient (>18 years)
• Indication to mild or moderate statin based on AHA 2013 guidelines
• Treatment naïve

Exclusion Criteria

• Allergy to rice
• Renal or hepatic terminal disease
• Any contra indication to statin treatment
• Pregnancy wish during study period
• Familial hypercholesterolemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Red rice yeast group	Red Rice Yeast Extract	Red rice yeast based product will be provided under the brand name Molval Fort, one pill a day, for 8 weeks, for a moderate intensity treatment equivalent according the American College of Cardiology/American Heart Association (ACC/AHA) guidelines definitions
Statin group	Statin	Statin choice is done at the discretion of the treating physician for a moderate intensity treatment equivalent according the American College of Cardiology/American Heart Association (ACC/AHA) guidelines definitions, for 8 weeks

Primary Outcome Measures

Name	Time	Method
LDL reduction	eight weeks	after an eight week treatment, cholesterol LDL levels' reduction is compared in the two groups

Secondary Outcome Measures

Name	Time	Method
incidence of side effects	eight weeks	after eight weeks of treatment, the incidence of side effects is studied among the red rice yeast group

Trial Locations

Locations (1)

Saint Anthony Primary Care Center; 🇱🇧 Jdeide, Lebanon