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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Red Yeast Rice; Dietary Supplement: Plant sterols; Dietary Supplement: Red Yeast Rice plus Plant sterols

• Registration Number: NCT02603276
• Lead Sponsor: University of Bologna

Brief Summary

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.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-11-09
• Study First Posted: 2015-11-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Red Yeast Rice	Red Yeast Rice	Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks
Red Yeast Rice plus Plant sterols	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
Red Yeast Rice plus Plant sterols	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
Plant sterols	Plant sterols	Plant sterols 800 mg per dose, 1 liquid stick per day, per 8 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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