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Completed

NCT Number: NCT03065491

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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

S. Orsola-Malpighi University Hospital

Bologna, BO, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined nutraceutical

Dietary Supplement

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

Placebo

Other

Oral administration: 1 tablet per day

Primary outcomes

  1. LDL-cholesterolemia absolute reduction from baseline and between groups

    Time frame: 8 weeks

    Absolute reduction of LDL-cholesterolemia after 8 weeks of treatment

  2. LDL-cholesterolemia % reduction from baseline and between groups

    Time frame: 8 weeks

    % reduction of LDL-cholesterolemia after 8 weeks of treatment

Secondary outcomes

  1. Flow-mediated dilation improvement from baseline and between groups

    Time frame: 8 weeks

    % vascular heath improvement after 8 weeks of treatment

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 28, 2017
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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