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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT02926118
Eligibility Criteria:
Inclusion Criteria:
* Apparently healthy males and post-menopausal females
* Age at start of the study ≥ 50 and ≤ 70 years
* Body mass index (BMI) ≥ 25.0 and ≤ 35.0 kg/m2
* Fasting blood glucose value of subjects is ≥ 3.4 and \< 6.1 mmol/L at screening
* Being used to eat three meals a day
* Having a general practitioner
* Agreeing to be informed about medically relevant personal test-results by a physician
* Accessible veins on arms as determined by examination at screening.
Exclusion Criteria:
* Having a medical conditions which might affect the study measurements (including but not limited to: diabetes type 1 and type 2, gastrointestinal disorders, gastrointestinal surgery and inflammatory diseases, as judged by the study physician
* Reported use of over-the-counter or prescribed medication or food supplements, which may interfere with study measurements as judged by the principal investigator
* Use of oral antibiotics in 40 days or less prior to the start of the study
* Reported participation in another nutritional or biomedical study 3 months before the screening or during the study
* Reported participation in night shift work 2 weeks prior to screening or during the study. Night work is defined as working between mid-night and 6.00 am
* Reported intense sporting activities \> 2h/w. Intense sporting activities are defined as those activities that cause a lack of breath which limits the ability to have a normal conversation
* Reported alcohol consumption \> 10 units/week (female) or \> 14 units/week (male)
* Reported use of any nicotine containing products in the 6 months preceding the study and willing to abstain from use of nicotine containing products during the study itself
* Reported dietary habits: medically prescribed diet, slimming diet, vegetarian
* Reported weight loss/gain (\> 3 kg) in the last 2 months before the study
* Being an employee of Unilever or research departments in NUTRIM or the Maastricht University Medical Centre (MUMC+) collaborating in this study
* Known allergy or intolerance to food products.
* Blood donation in the past 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT02926118
Study Brief:
Protocol Section:
NCT02926118