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

NCT06368258 | Not Yet Recruiting

• 1 other identifier: Curr-RYR2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypercholesterolemia

Keywords

Red yeast rice; Monacolins; Dietary supplement; Randomized clinical study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Treatment-dependent change in Total Cholesterol

  6 weeks

• Treatment-dependent change in Non-HDL-C

  6 weeks

• Treatment-dependent change in liver parameters

  6 weeks

• Treatment-dependent change in CPK plasma levels

  6 weeks

• Treatment-dependent change in plasma proteomic pattern

  6 weeks

Study Arms (2)

Dietary supplement

ACTIVE COMPARATOR

Dietary Supplement: Red yeast rice

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Red yeast rice DIETARY_SUPPLEMENT

Red yeast rice 160 mg (total monacolins 2.8 mg)

Dietary supplement

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

AOU Policlinico S.Orsola-Malpighi

Bologna, Italy

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

red yeast rice

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 16, 2024
• Study Start: May 2, 2024
• Primary Completion: December 1, 2024
• Study Completion: May 2, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)