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

Primary Purpose

Dyslipidemias, LDL Hyperlipoproteinemia

Status
Unknown status
Phase
Phase 2
Locations
Lebanon
Study Type
Interventional
Intervention
Red Rice Yeast Extract
Statin
Sponsored by
Saint-Joseph University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring statins, red rice yeast, adverse effects, cholesterol, LDL, treatment outcome, tolerability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Saint Anthony Primary Care CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Red rice yeast group

Statin group

Arm Description

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 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2018
Last Updated
October 4, 2019
Sponsor
Saint-Joseph University
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1. Study Identification

Unique Protocol Identification Number
NCT03607383
Brief Title
Red Rice Yeast in Low-density Lipoprotein (LDL) Lowering: an Efficacy Study
Official Title
Red Rice Yeast in Low-density Lipoprotein (LDL) Lowering: an Efficacy Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 7, 2018 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint-Joseph University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, LDL Hyperlipoproteinemia
Keywords
statins, red rice yeast, adverse effects, cholesterol, LDL, treatment outcome, tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Red rice yeast group
Arm Type
Experimental
Arm Description
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
Arm Title
Statin group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Red Rice Yeast Extract
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Statin
Intervention Description
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 Measure Information:
Title
LDL reduction
Description
after an eight week treatment, cholesterol LDL levels' reduction is compared in the two groups
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
incidence of side effects
Description
after eight weeks of treatment, the incidence of side effects is studied among the red rice yeast group
Time Frame
eight weeks
Other Pre-specified Outcome Measures:
Title
physician and patient satisfaction
Description
physician and patient satisfaction will be evaluated by a single question questionnaire: Were you satisfied by the treatment?
Time Frame
eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marouan Zoghbi
Phone
9613552317
Email
marouan.zoghbi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ralph Mezher
Phone
96171425999
Email
ralph.mezher.RM@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marouan Zoghbi
Organizational Affiliation
Hôtel Dieu de France Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Anthony Primary Care Center
City
Jdeide
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marouan Zoghbi, MD
Phone
+9613552317

12. IPD Sharing Statement

Plan to Share IPD
No

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

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