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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT03901157
Eligibility Criteria:
Inclusion Criteria:
* Based on medical history and previous examination, no serious gastrointestinal complaints can be defined;
* Age between 18 and 65 years. This study will include healthy adult subjects (male and female);
* BMI between 25-30 kg/m2;
* Able to participate in the study, willing to give informed consent and to comply with the study procedures and restrictions;
* Weight stable over at least the last 6 months (self-admitted; ≤5% weight change).
Exclusion Criteria:
* Self-admitted milk (-protein or lactose)- allergy/intolerance;
* Self-admitted history of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, haematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided and documented by the principal investigator;
* Use of medication that can influence study end-points (to be decided by medical doctor and principal investigator), including vitamin supplementation, within 14 days prior to testing;
* Administration of investigational drugs or participation in any scientific intervention study that may interfere with this study, to be decided by the principal investigator prior to the study;
* Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery) upon judgement of the principal investigator;
* Dieting (medically prescribed, diabetic and vegetarian);
* Pregnancy, lactation (both self-admitted);
* Excessive alcohol consumption (\>20 alcoholic units per week);
* Smoking;
* Self-admitted HIV-positive state.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03901157
Study Brief:
Protocol Section:
NCT03901157