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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Combined nutraceutical; Other: Placebo

• Registration Number: NCT03065491
• Lead Sponsor: University of Bologna

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-11-15
• Status Verified: 2017-02
• Primary Completion: 2017-02-15
• Study First Submitted: 2017-02-15
• Study Completion: 2017-02-17
• Study First Submitted QC: 2017-02-22
• Last Update Submitted: 2017-02-22
• Study First Posted: 2017-02-28
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active treatment	Combined nutraceutical	Combined nutraceutical
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
LDL-cholesterolemia absolute reduction from baseline and between groups	8 weeks	Absolute reduction of LDL-cholesterolemia after 8 weeks of treatment
LDL-cholesterolemia % reduction from baseline and between groups	8 weeks	% reduction of LDL-cholesterolemia after 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Flow-mediated dilation improvement from baseline and between groups	8 weeks	% vascular heath improvement after 8 weeks of treatment

Trial Locations

Locations (1)

S. Orsola-Malpighi University Hospital; 🇮🇹 Bologna, BO, Italy