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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT00776256
Eligibility Criteria:
Inclusion Criteria:
* Age at start of the study 18 till 60 years
* Quetelet-Index (BMI) from 21 till 32 kg/m2 inclusive
* Apparently healthy: measured by questionnaire: no reported current or previous metabolic diseases or chronic gastrointestinal disorders
* Reported dietary habits: no medically prescribed diet, no slimming diet, used to eat 3 meals a day, no vegetarian, macro-biotic or biologic dynamic food habits
* No Fibre supplements (only once a day)
* No blood donations during the study.
* Reported intense sporting activities less than 10h/w
* Reported alcohol consumption less than 21 units/w (female volunteers) or less than 28 units/w (male volunteers)
* Having a General Practitioner
* Informed consent signed
* Recruitment form filled out
Exclusion Criteria:
* Smoking
* Dislike, allergy/intolerance or not known with the foods of the ad libitum meal
* Possible eating disorder (measured by SCOFF questionnaire)
* High or very high restrained eaters (measured by questionnaire) (men with BMI \< 27: restraint score \> 2.37, men with BMI less than 27: restraint score \> 3.04, women with BMI \< 26: restraint score \> 3.24, women with BMI less than 26: restraint score \> 3.41)
* Reported medical treatment that may affect eating habits/satiety
* Reported intolerance or allergy to test products
* Women reported lactating (or lactating \< 6 weeks ago), pregnant (or pregnant \< 3 months ago) or wish to become pregnant during the study
* Reported weight loss/gain (10%) in the last six month before the trial
* Reported participation in another biomedical trial 1 month before the start of the study
* Reported working on late turns -
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00776256
Study Brief:
Protocol Section:
NCT00776256