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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT02635659
Eligibility Criteria:
Inclusion Criteria:
* Based on medical history and previous examination, no gastrointestinal complaints can be defined.
* Age between 18 and 65 years. A higher age comes with a higher chance of comorbidities. These could influence our study outcomes and therefore this age range was chosen. This study will include healthy adult subjects (male and female). Women must be taking contraceptives (only needed in women with childbearing potential)
* BMI between 25 -30 kg/m2
* Normal Dutch eating habits eating three meals a day including breakfast as assessed by a validated questionnaire
* Voluntary participation
* Able to participate in the study, willing to give informed consent and to comply with the study procedures and restrictions
Exclusion Criteria:
* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/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 any medication, except oral contraceptives, which may interfere with this study (major interference with the execution of the experiment or potential influence on the study outcomes). This has to be decided and documented by the principle investigator.
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study, to be decided by the principle investigator, in the 90 days prior to the study.
* Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery) upon judgement of the principle investigator.
* Dieting (medically prescribed, diabetic and vegetarian)
* Pregnancy, lactation
* Excessive alcohol consumption (\>20 alcoholic consumptions per week)
* Intention to stop smoking
* Self-admitted HIV-positive state
* Above average score (\>2.26) on the restrained eating scale of the Dutch Eating Behaviour Questionnaire
* Reported unexplained weight loss or gain of \>4 kg in the month prior to screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02635659
Study Brief:
Protocol Section:
NCT02635659