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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT04418102
Eligibility Criteria:
Inclusion Criteria:
* Healthy (free of diagnosed diseases listed in exclusion criteria).
* Able to give informed consent.
* Able to give informed consent.
* Accessible veins on arms as determined by examination at screening
Exclusion Criteria:
* Having a medical condition or history which might impact study measurements, to be judged by the study physician (e.g. myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes)
* Use of plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study
* Body mass index \< 20 kg/m2 or \> 35 kg/m2
* Plasma cholesterol ≥7.5 mmol/L
* Plasma triacylglycerol \> 3 mmol/L
* Plasma glucose \> 7 mmol/L
* Full blood count (FBC), liver function out of healthy range
* Blood pressure ≥140/90 mmHg
* Current use of antihypertensive or lipid lowering medications
* Use of over-the-counter and prescribed medication, which may interfere with study measurements (to be judged by the principal investigator)
* Alcohol intake exceeding a moderate intake (\> 21 units per week)
* Current cigarette smoker (or quit within last 6 months)
* ≥ 20% 10-year risk of cardiovascular disease (CVD) as calculated using a risk calculator
* Active blood donor or plans to donate blood within 6 months of study completion
* Use of oral antibiotics (with the exception of topical antibiotics) in 40 days or less prior to the start of the study
* Reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening
* Reported dietary habits: medically prescribed diet, allergy/intolerance to test products that will be provided during the study
* Reported participation in another nutritional or biomedical trial 3 months prior to screening
* Reported participation in night shift work 2 weeks prior to screening and/or during the study. Night work is defined as working between midnight and 6.00 am Anyone who has given blood in the last 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT04418102
Study Brief:
Protocol Section:
NCT04418102