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 @ 12:44 PM
Ignite Modification Date:
2025-12-24 @ 12:44 PM
NCT ID:
NCT05120661
Eligibility Criteria:
Inclusion Criteria:
* Males and females
* BMI≥25 kg/m2
* Age 40-75 years
* Signed informed consent
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 type 1, a swallowing disorder, gastrointestinal or liver disease, renal failure, cancer, nose/throat diseases, gastric bypass surgery, use of anticoagulants;
* Having a bleeding/coagulation disorder, including hemophilia, Von Willebrand disease, Bernard-Soulier, Glanzmann thrombasthenia or thrombocytopenia;
* Use of antibiotics within 2 months of starting the study or planned during the study;
* Use of medication that could influence the study results, such as diabetes treatment;
* Use of pro- and prebiotic supplements;
* Sensitive to medical skin adhesives;
* Having an allergy or intolerance towards compounds in the test products;
* Follows a vegan diet;
* Excessive alcohol consumption (on average \>21 glasses/week for men and \>14 glasses/week for women);
* Currently a research subject in another clinical trial;
* Having blood vessels that are too difficult for inserting a cannula/blood drawing'
* Having a hemoglobin level \<8.5 mmol/l (men) or \<7.5 mmol/l (women);
* Being a blood donor during the duration of the study;
* Not having a General Practitioner (GP);
* Being an employee of Wageningen University, division Human Nutrition and Health.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT05120661
Study Brief:
Protocol Section:
NCT05120661