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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT06064266
Eligibility Criteria:
Inclusion Criteria:
* Adult male or female
* BMI 18.5-30 kg/m2
* Suitable veins for insertion of cannula
Exclusion Criteria:
* Having a history of medical or surgical events that may either put the subject at risk because of participation in the study, or influence the results of the study, including diabetes mellitus, dyslipidemia, a swallowing disorder, gastrointestinal or liver disease, irritable bowel syndrome, sleeping apnea, renal failure, cancer, nose/throat diseases, gastric bypass surgery, use of anticoagulants; as determined by the medical supervisor;
* Having a bleeding/coagulation disorder, including hemophilia, Von Willebrand disease, Bernard-Soulier, Glanzmann thrombasthenia or thrombocytopenia;
* Use of antibiotics within 3 months of starting the study or planned during the study;
* Use of any medications in the previous week that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA), as determined by medical supervisor;
* Use of pro- and prebiotic supplements within 4 weeks of starting the study;
* Planning or scheduled to undergo magnetic resonance imaging (MRI) at any time during the course of the study (the SIMBA Capsule is MR unsafe)
* Currently following a very low carbohydrate (ketogenic) diet;
* Having regularly less than 3 bowel movements per week (being constipated);
* Alcohol consumption \>21 glasses a week (women) or \>28 glasses a week (men);
* Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported);
* Not willing to give up blood donation during the study;
* Food allergies or intolerances for products that we use in the study;
* Current smokers;
* Current users 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:
18 Years
Study:
NCT06064266
Study Brief:
Protocol Section:
NCT06064266