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

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.

Study Overview

• Status: Unknown
• Conditions: Dyslipidemias; LDL Hyperlipoproteinemia
• Intervention / Treatment: Drug: Red Rice Yeast Extract; Drug: Statin

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Marouan Zoghbi; Phone Number: 9613552317; Email: marouan.zoghbi@gmail.com
• Study Contact Backup: Name: Ralph Mezher; Phone Number: 96171425999; Email: ralph.mezher.RM@gmail.com

Study Locations

• Lebanon
  • Jdeide, Lebanon
    • Recruiting
    • Saint Anthony Primary Care Center
    • Contact: Marouan Zoghbi, MD; Phone Number: +9613552317

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Red rice yeast group; 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	Drug: Red Rice Yeast Extract; adults requiring moderate intensity treatment will be provided red rice yeast extracts or statins, depending on the randomization; followed for compliance and adverse effects check, and reevaluated in a final visit with blood test after 8 weeks
Active Comparator: Statin group; 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	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL reduction	after an eight week treatment, cholesterol LDL levels' reduction is compared in the two groups	eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of side effects	after eight weeks of treatment, the incidence of side effects is studied among the red rice yeast group	eight weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
physician and patient satisfaction	physician and patient satisfaction will be evaluated by a single question questionnaire: Were you satisfied by the treatment?	eight weeks

Collaborators and Investigators

• Sponsor: Saint-Joseph University
• Investigators: Principal Investigator: Marouan Zoghbi, Hotel Dieu de France Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2018
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: July 29, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 4, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: tolerability; treatment outcome; adverse effects; statins; red rice yeast; cholesterol, LDL
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Red yeast rice
• Other Study ID Numbers: RRY2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No