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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT04574505
Eligibility Criteria:
Inclusion Criteria:
* Subjects agree to participate in the study and having dated and signed the informed consent form.
* Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
* Male or female aged ≥ 18 years and ≤ 70 years old.
* LDL-Cholesterol plasma levels \>115 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 2019, the intervention strategy does not require a pharmacological lipid lowering intervention.
Exclusion Criteria:
* Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk\> 5%;
* Obesity (BMI\>30 kg/m2) or diabetes mellitus;
* Assumption of lipid lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
* Antihypertensive treatment not stabilized since at least 3 months;
* Anticoagulants therapy
* Uncontrolled hypertension (systolic blood pressure\> 190 mmHg or diastolic arterial pressure\> 100 mmHg);
* Known current thyroid, gastrointestinal or hepatobiliary diseases;
* Any medical or surgical condition that would limit the patient adhesion to the study protocol;
* Abuse of alcohol or drugs (current or previous);
* History of malignant neoplasia in the 5 years prior to enrolment in the study;
* History or clinical evidence of inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids;
* History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
* Known previous intolerance to one component of the tested nutraceuticals
* Women in fertile age not using consolidated contraceptive methods
* Pregnancy and Breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04574505
Study Brief:
Protocol Section:
NCT04574505