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:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-26 @ 5:20 PM
NCT ID:
NCT02446106
Eligibility Criteria:
Inclusion Criteria:
* Healthy Premenopausal Female, 19 to 60 yrs old
* Non-smoker
* Non-heavy Drinker
* BMI between 25 and 39.9 inclusive at the screening visit (with average BMI 30)
* no reported current or previous metabolic diseases or chronic gastrointestinal disorders
* no medically prescribed diet, no slimming diet, used to eating 3 meals a day and snacking
* No blood donation during the study
* Reported intense sporting activities ≤ 10h/w
* Reported alcohol consumption ≤14 units/w
* Informed consent signed
* Recruitment form filled out
Exclusion Criteria:
* Smoker
* Vegetarian
* Disliking the meals provided on the test day, have allergy or intolerance to test products or study meals
* Use of medication which interferes with study measurements (as judged by the study physician).
* Possible eating disorder (measured by SCOFF questionnaire score \>1)
* Current depression measured by BDI \<10
* Pregnant during the study period or in the six months prior to pre-study investigation
* Reported lactating 6 weeks before pre-study investigation and during the study
* Reported weight loss or gain ≥ 10 % of bodyweight during a period of six months before pre-study examination.
* Eating disorder (measured by SCOFF questionnaire, ≥2 "yes" responses)
* Reported participation in another biomedical trial 1 month before the start of the study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
19 Years
Maximum Age:
60 Years
Study:
NCT02446106
Study Brief:
Protocol Section:
NCT02446106