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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: Combined nutraceutical; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • S. Orsola-Malpighi University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Oral administration: 1 tablet per day
Active Comparator: Active treatment; Combined nutraceutical	Dietary supplement: Combined nutraceutical; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Bologna

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2016
• Primary Completion (Actual): February 15, 2017
• Study Completion (Actual): February 17, 2017

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Endothelial function; Lipids; Red yeast rice; Phytosterols; L-Tyrosol; LDL-cholesterol
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: MPT_trial_2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No