Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function

Study Overview
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Brief Summary
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A large body of evidence confirm the cholesterol lowering effect of red yeast rice, phytosterols and L-tyrosol. 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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European Food Safety Authority approves some health claim related to the cardiometabolic effects of some nutraceuticals, and in particular of red yeast rice, phytosterols and L-tyrosol. In a previous study the investigators have already demonstrated the synergistic effect of red yeast rice and phytosterols in term of lipid-lowering activity. Preliminary data suggest that these nutraceuticals could also exert a positive effect on vascular health beyond the direct effects on serum lipids. No data are available on the combined effects of these dietary supplement in humans.

Official Title
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Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function: a Double-blind, Placebo-controlled, Randomized Clinical Trial

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Combined nutraceutical
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suboptimal LDL level (115-160 mg/dL) TG<400 mg/dL Signed informed consent form Exclusion Criteria: Patients already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk> 10 years LDL-C<115 mg/dL or >160 mg/dL, TG>400 mg/dL Obesity (BMI>30 kg/m2) or diabetes mellitus Assumption of lipid lowering drugs or dietary supplements, or drugs potentially affecting the lipid metabolism Antihypertensive treatment not stabilized since at least 3 months Known current thyroid, gastrointestinal or liver diseases Any medical or surgical condition that would limit the patient adhesion to the study protocol

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: Active treatment<br>Combined nutraceutical | Dietary Supplement: Combined nutraceutical<br>* Plant sterols 800 mg + Red Yeast Rice containing 5 mg monacolin K + L-Tyrosol 50 mg per daily dose Oral administration: 1 tablet per day<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Oral administration: 1 tablet per day<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated dilation improvement from baseline and between groups | % vascular heath improvement after 8 weeks of treatment | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Red yeast rice, Phytosterols, L-Tyrosol, Lipids, LDL-cholesterol, Endothelial function