Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination

Study Overview
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Brief Summary
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A large body of evidence confirm the cholesterol lowering effect of phytosterols and red yeast rice. Because their mechanisms of action mime the ones of chemical statins and cholesterol absorption inhibitors, it is plausible that their association will provide a more relevant (and safe) LDL cholesterolemia reduction.

Detailed Description
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A large body of literature suggest that the patients are strongly interested in self-medicating them with natural products aimed at reducing their plasma level of LDL-cholesterol. Plant sterols and red yeast rice are among the most widely marketed product with these properties in Western countries. However plant sterols per se have a limited effect on cholesterolemia, while full dosed red yeast rice can induce myalgias and myopathies as statins do. In this context, the aim of the investigators' study was to evaluate if the association of both products at low dosage could induce an additive or synergistic effect in term of LDL-reduction in humans.

Official Title
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Lipid-lowering Effect of Phytosterols, Red Yeast Rice and Their Combination in Moderately Hypercholesterolemic Subjects in Primary Prevention for Cardiovascular Diseases: a Randomized, Double Blind, Clinical Trial

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Plant sterols
* Dietary Supplement: Red Yeast Rice
* Dietary Supplement: Red Yeast Rice plus Plant sterols


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LDL-cholesterolemia between 130 and 190 mg/dL Exclusion Criteria: Type 2 diabetes Previous cardiovascular disease Assumption of lipid-lowering drugs or dietary supplements Previous intolerance to red yeast rice

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plant sterols<br>Plant sterols 800 mg per dose, 1 liquid stick per day, per 8 weeks | Dietary Supplement: Plant sterols<br>* Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks<br>|
| Active Comparator: Red Yeast Rice<br>Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks | Dietary Supplement: Red Yeast Rice<br>* Red Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks<br>|
| Experimental: Red Yeast Rice plus Plant sterols<br>lant sterols 800 mg per dose + Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks | Dietary Supplement: Plant sterols<br>* Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks<br>Dietary Supplement: Red Yeast Rice plus Plant sterols<br>* Red Yeast Rice titrated in 5 mg monacolin K per daily dose plus Plant sterols 800 mg/dose, together in 1 liquid stick per day, for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL cholesterolemia reduction from baseline and between groups | Absolute and % reduction of LDL cholesterolemia after 8 weeks of treatment | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-HDL cholesterolemia reduction from baseline and between groups | Absolute and % reduction of of non-HDL cholesterolemia after 8 weeks of treatment | 8 weeks | 
| Number of Participants With Treatment-Related Adverse Events | Subjective tolerability of the tested treatment | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypercholesterolemia, dietary supplements, red yeast rice, plant sterols