Middle Term Effect of Red Yeast Rice on Plasma Lipids and Proteoma in Individuals With Suboptimal Cholesterolemia

Randomized Clinical Trial to Evaluate the Middle Term Effect of a Dietary Supplement Containing Red Yeast Rice (Total Monacolin <3 mg/Dose) or Placebo on Plasma Lipids and Proteoma in Subjects With Suboptimal Cholesterolemia

The primary purpose of our research will be to evaluate if, in healthy subjects with a low- moderate cardiovascular risk (CV risk>1% but < 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol >115 mg/dL, < 190 mg/dL) supplementation with a red yeast rice food supplement containing less than 3 mg total monacolins per daily dose is able to significantly influence plasma lipid levels. Furthermore, liver and muscle proteomic pattern and vascular response to dietary supplementation will be investigated.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Other: Placebo; Dietary supplement: Red yeast rice

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy
    • AOU Policlinico S.Orsola-Malpighi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female aged ≥ 30 years and ≤ 70 years old.
• Body Mass Index included between 18 Kg/m2 and 35 Kg/m2
• Total cholesterolemia between 200 and 280 mg/dL and/or LDL-Cholesterol between 130 mg/dL and 190 mg/dL.
• TG<400 mg/dL.
• Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk < 5%) and for whom, according to ESC/EAS guidelines 2012, the intervention strategy does not require a pharmacological lipid-lowering intervention.
• Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
• Subjects agree to participate in the study and having dated and signed the informed consent form.

Exclusion Criteria:

• Assumption of lipid lowering drugs or dietary supplements, or drugs potentially affecting the lipid metabolism;
• Assumption of any kind of drug treatment non-stabilized for at least 3 months;
• Known current thyroid, gastrointestinal or hepatobiliary diseases (including liver transaminases ≥3ULN), as well as any muscular disorders (even subclinical, including serum CPK ≥3ULN);
• Current or previous alcohol abuse;
• Pregnancy and Breastfeeding
• Known previous intolerance to red yeast rice
• History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
• 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: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo
Active Comparator: Dietary supplement	Dietary supplement: Red yeast rice; Red yeast rice 160 mg (total monacolins 2.8 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-dependent change in LDL-C	The primary objective is to evaluate the effect of the tested dietary supplement containing less than 3 mg of total monacolins per daily dose on LDL cholesterol level versus placebo after 6 weeks of treatment vs placebo in healthy subjects with suboptimal cholesterolemia	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-dependent change in Total Cholesterol	To compare the effect of the tested dietary supplement on total cholesterol level after 6 weeks of treatment vs placebo vs placebo in healthy subjects with suboptimal cholesterolemia	6 weeks
Treatment-dependent change in Non-HDL-C	To compare the effect of the tested dietary supplement on Non-HDL cholesterol level after 6 weeks of treatment vs placebo vs placebo in healthy subjects with suboptimal cholesterolemia	6 weeks
Treatment-dependent change in liver parameters	To evaluate if the tested dietary supplement is associated with changes in liver parameters (i.e. AST, ALT, gamma-GT) vs placebo in healthy subjects with suboptimal cholesterolemia	6 weeks
Treatment-dependent change in CPK plasma levels	To evaluate if the tested dietary supplement is associated with changes in CPK plasma levels compared to placebo in healthy subjects with suboptimal cholesterolemia	6 weeks
Treatment-dependent change in plasma proteomic pattern	To evaluate if the tested dietary supplement is associated with significant changes on plasma proteomic pattern with focus on liver and muscle protein parameters in healthy subjects with suboptimal cholesterolemia. Protein abundances will be calculated with the generation of spectral features by the node FeatureFinderMultiplex followed by PIA-assisted FDR-multiple scores estimation and filtering (combined FDR score<0.01), their ID mapping and combination with peptide IDs, their subsequent alignment, grouping and normalization (e.g., MapAlignerIdentification, FeatureUnlabeledQT and ConsensusmapNormalizer nodes).	6 weeks

Collaborators and Investigators

• Sponsor: University of Bologna

Study record dates

Study Major Dates

• Study Start (Estimated): May 2, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): May 2, 2025

Study Registration Dates

• First Submitted: April 7, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Dietary supplement; Red yeast rice; Randomized clinical study; Monacolins
• 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: Curr-RYR2023

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