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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT06108505
Eligibility Criteria:
Inclusion Criteria:
1. Adult participants of either sex with ages between 18 and 70 years (limits included).
2. Participants with serum LDL-C ≥116 mg/dl.
3. Body Mass Index (BMI) between 18.5 and 35 kg/m2 (limits excluded).
Exclusion Criteria:
1. Subjects who systematically receive any other lipid-lowering non-medicinal product, supplement or functional food such as ACTIMEL, ACTIVIA, oat beta-glucan, pharmaceutical garlic, or stopped less than 1 month prior to study inclusion.
2. Participants that have been under lipid-lowering drug treatment (e.g. statins, fibrates, etc.) or any other medication that has a significant effect on LDL-c within the last 2 months prior to study inclusion.
3. Lactating females or those that are planning pregnancy within 6 months from the start of the study.
4. Participants with a history of ischemic cardiovascular events, alcohol abuse, or suffering from a severe chronic disease (e.g. cancer, diabetes, chronic advanced kidney disease, thyroid disorders, hepatic disorders, cancer, familial hypercholesterolemia or immunosuppression) that would potentially affect the outcomes of the study.
5. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
6. Subjects with a known intolerance or allergy to any ingredient of the administered products.
7. Participants who are planning on making significant changes in their diet, lifestyle, and physical activity during the duration of the study, i.e. participants that are currently on weight-reducing diets.
8. Participants who are receiving any interventional procedure or are currently included in a clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06108505
Study Brief:
Protocol Section:
NCT06108505