Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT06368258
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT06368258
Study Brief:
Protocol Section:
NCT06368258