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

NCT ID: NCT06368258

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2025-05-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dietary supplement

Group Type: ACTIVE_COMPARATOR

Red yeast rice

Intervention Type: DIETARY_SUPPLEMENT

Red yeast rice 160 mg (total monacolins 2.8 mg)

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

Red yeast rice

Red yeast rice 160 mg (total monacolins 2.8 mg)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Arrigo F.G. Cicero

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AOU Policlinico S.Orsola-Malpighi

Bologna, , Italy

Countries

Italy

Other Identifiers

Curr-RYR2023

Identifier Type: -

Identifier Source: org_study_id