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:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT02835651
Eligibility Criteria:
Inclusion Criteria:
* Apparently healthy men and post-menopausal women (post-menopausal for at least one year) as judged by study physician
* BMI ≥ 18.0 and ≤ 30.0 kg/m2
* Aged between 45 and 70 years
* Willing to comply to study protocol during study
* Having a general practitioner
* Agreeing to be informed about medically relevant personal test-results by a physician
* Informed consent signed
* Accessible veins on arms as determined by examination at screening
Exclusion Criteria:
* Having a medical condition which might impact study measurements
* Use of over-the-counter and prescribed medication, which may interfere with study measurements
* Use of oral antibiotics in 40 days or less prior to the start of the study;
* Use of food supplements or plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study;
* Reported alcohol consumption ≥ 10 units/week (female) or ≥ 14 units/week (male);
* Reported intense sporting activities ≥ 10 hours/week;
* Reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening
* Regular smokers (at least one cigarette (or equivalent) daily or \>7 cigarettes (or equivalent) weekly. Smokers who cannot comfortably restrain from smoking for up to 2 days will also be excluded
* Reported dietary habits: medically prescribed diet, allergy/intolerance to test products that will be provided during the study
* Blood donation in the past 3 months
* Drug abuse
* Reported participation in another nutritional or biomedical trial 3 months prior to screening
* Fasting triacylglycerol concentrations at screening: ≥ 4.5 mmol/L
* Serum lipids: treatment recommended according to the "Multidisciplinary guidelines Cardiovascular risk management"
* Fasting HbA1c ≥ 48 mmol/mol (or 6.5%)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT02835651
Study Brief:
Protocol Section:
NCT02835651