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

University of Bologna

Status

Not yet enrolling

Conditions

Hypercholesterolemia

Treatments

Dietary Supplement: Red yeast rice

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06368258

Curr-RYR2023

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.