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

NCT03607383 — Phase 2, Unknown, 40 participants, Saint-Joseph University

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Registry	NCT03607383
Status	Unknown
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	40 (Estimated)
Sponsor	Saint-Joseph University (Other)
Conditions	Dyslipidemias, LDL Hyperlipoproteinemia
Interventions	Red Rice Yeast Extract, Statin (Drug)
Dates	start 2018-02-07, primary completion 2020-04-30 (estimated), completion 2020-04-30 (estimated), first posted 2018-07-31, last updated 2019-10-08
Locations	1 site in Lebanon

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Red rice yeast group	Experimental	Drug: 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	Active comparator	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

Red Rice Yeast Extract (Drug): 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
Statin (Drug): 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

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

Other outcomes

physician and patient satisfaction [eight weeks]: physician and patient satisfaction will be evaluated by a single question questionnaire: Were you satisfied by the treatment?

+Eligibility

Sex: All, ages: 18 Years to any, accepts 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

+Locations (1)

Facility	City	Country	Status
Saint Anthony Primary Care Center	Jdeïdé	Lebanon	Recruiting

+Investigators

Marouan Zoghbi, Principal investigator, Hôtel Dieu de France Hospital