Skip to main content
OpenTrials
Completed

NCT Number: NCT02603276

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

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.

Completed

Looking for future studies?

Notify Me

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, 40038, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Plant Sterols

Dietary Supplement

Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks

red yeast rice

Dietary Supplement

Red Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks

Red Yeast Rice plus Plant sterols

Dietary Supplement

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

Primary outcomes

  1. LDL cholesterolemia reduction from baseline and between groups

    Time frame: 8 weeks

    Absolute and % reduction of LDL cholesterolemia after 8 weeks of treatment

Secondary outcomes

  1. Non-HDL cholesterolemia reduction from baseline and between groups

    Time frame: 8 weeks

    Absolute and % reduction of of non-HDL cholesterolemia after 8 weeks of treatment

  2. Number of Participants With Treatment-Related Adverse Events

    Time frame: 8 weeks

    Subjective tolerability of the tested treatment

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 11, 2015
Registry last updated
Feb 1, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.