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:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT03312816
Eligibility Criteria:
Inclusion Criteria:
* Apparently healthy men and women as judged by study physician.
* BMI \> 18 and \< 35 kg/m2.
* Total cholesterol levels at screening ≥5.0 and ≤8.0 mmol/L
* Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by the study physician.
Exclusion Criteria:
* Recently (\<6 months) diagnosed with cardiovascular event(s) (stroke, TIA (Transient ischemic attack), angina, myocardial infarction, heart failure), revascularization or systemic inflammatory conditions.
* Use of plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study.
* Use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. statins, ezetimibe, fibrates, diabetic drugs, angiotensin receptor blockers (ARB) and ACE (Angiotensin-converting enzyme) inhibitors)), to be judged by the principal investigator.
* Use of oral antibiotics (with the exception of topical antibiotics) in 40 days or less prior to Day -2.
* Pregnant or lactating women.
* Reported alcohol consumption \> 14 units/week (female) or \> 21 units/week (male).
* Reported intense sporting activities \> 10 hours/week.
* Reported weight loss or gain of 3 kg or more during a period of 6 months prior to screening.
* Currently on a medically- or self-prescribed diet, or slimming diet, or the intention to use any kind of diet during the study.
* Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT03312816
Study Brief:
Protocol Section:
NCT03312816