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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT05313594
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Age 45-75 y
* BMI 25-35 kg/m2
* Suitable veins for insertion of cannula
Exclusion Criteria:
* Having a gastro-intestinal disease, such as celiac disease, Crohn's disease, or Ulcerative colitis
* Having a history of intestinal surgery that might interfere with study outcomes, as determined by the medical supervisor. This does not include an appendectomy or cholecystectomy
* Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease, as determined by the medical supervisor
* Use of medications known to interfere with glucose or lipid homeostasis (e.g. corticosteroids, cholesterol-lowering medication, insulin, metformin), as determined by medical supervisor
* Blood clotting disorders
* Unstable body weight (weight gain or loss \>3 kg in the past three months)
* Reported slimming, medically prescribed or other extreme diets
* Alcohol consumption \>21 glasses a week
* Anaemia (Hb values \<7.5 mmol/L for women and \<8.5 mmol/L for men; checked at screening)
* Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
* Having a pacemaker, implantable cardioverter-defibrillator, hearing implant, internal insulin pump, neurostimulator, aneurysm clips placed before 1990, or metal splinter in the eye
* Having claustrophobia
* Not willing to give up blood donation during the study
* Food allergies or intolerances for products that we use in the study
* Unwilling to consume non-vegan test meal
* Recent use of antibiotics (\<3 months prior to study start)
* Current smokers
* Abuse of soft and/or hard drugs
* Participation in another clinical trial at the same time
* Being an employee of the Food, Health \& Consumer Research group of Wageningen Food \& Biobased Research or Human Nutrition and Health Department of Wageningen University
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT05313594
Study Brief:
Protocol Section:
NCT05313594