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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: Plant sterols; Dietary supplement: Red Yeast Rice; Dietary supplement: Red Yeast Rice plus Plant sterols

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40038
    • S. Orsola-Malpighi University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Plant sterols; Plant sterols 800 mg per dose, 1 liquid stick per day, per 8 weeks	Dietary supplement: Plant sterols; Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks
Active Comparator: Red Yeast Rice; Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks	Dietary supplement: Red Yeast Rice; Red Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks
Experimental: Red Yeast Rice plus Plant sterols; lant sterols 800 mg per dose + Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks	Dietary supplement: Plant sterols; Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks; Dietary supplement: Red Yeast Rice plus Plant sterols; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-HDL cholesterolemia reduction from baseline and between groups	Absolute and % reduction of of non-HDL cholesterolemia after 8 weeks of treatment	8 weeks
Number of Participants With Treatment-Related Adverse Events	Subjective tolerability of the tested treatment	8 weeks

Collaborators and Investigators

• Sponsor: University of Bologna
• Investigators: Principal Investigator: Claudio Borghi, MD, University of Bologna

Publications and helpful links

General Publications

• Cicero AFG, Fogacci F, Rosticci M, Parini A, Giovannini M, Veronesi M, D'Addato S, Borghi C. Effect of a short-term dietary supplementation with phytosterols, red yeast rice or both on lipid pattern in moderately hypercholesterolemic subjects: a three-arm, double-blind, randomized clinical trial. Nutr Metab (Lond). 2017 Sep 25;14:61. doi: 10.1186/s12986-017-0214-2. eCollection 2017. Erratum In: Nutr Metab (Lond). 2018 Jun 20;15:44.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: November 9, 2015
• First Posted (Estimated): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: dietary supplements; hypercholesterolemia; plant sterols; red yeast rice
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Red yeast rice
• Other Study ID Numbers: PhytoRed