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 @ 7:37 PM
Ignite Modification Date:
2025-12-24 @ 7:37 PM
NCT ID:
NCT02353403
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) between 18.0 and 25.0 kg/m² (included)
* Ready to keep the same volume of physical activity and the same dietary habits during the study and particularly 24 hours before each visit
* Be used to have breakfast
* Non-smoker for at least 3 months
* For the female participant: not being pregnant or breastfeeding and using efficient birth control
* Signed the consent form
* Able to follow the instructions of the study
* Health insured
* Accepted to be included in the National Registry for biomedical research Volunteers (Fichier VRB, Volontaires Recherches Biomédicales).
Exclusion Criteria:
* Fasting blood glucose over 6.1 mmol/L (1.10 g/L) (or diabetes treated or not)
* Fasting blood cholesterol over 6.35 mmol/L
* Fasting blood triglycerides over 1.70 mmol/L (or history of insulinoma)
* Fasting blood insulin under 20 mU/L
* Fasting HbA1c under 7%
* History of hypercholesterolemia, hypertension, diabetes or glucose intolerance treated or not
* History of dietary allergies or coeliac disease
* History of digestive system disease susceptible to modify digestion or absorption like Crohn's disease
* Somatic or psychiatric disorders
* Renal insufficiency (kidney failure)
* SGOT or ALAT over 52.5 U/L
* Smoker
* Consuming more than 3 alcoholic beverage a day
* Weight varied 3 kg the last 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02353403
Study Brief:
Protocol Section:
NCT02353403