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 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT03265392
Eligibility Criteria:
Inclusion Criteria:
* To be overall healthy
* To be between 18 and 60 years old
* BMI between 18 and 25 (lean)
* No eating disorders
* No major weight changes (\> 3kg in previous 3 months)
* Structured eating habits (3 main meals/day, everyday)
* Not using corticoid drugs, or antidepressives known to influence food consumption, appetite and/or mood.
* Not using medication known to influence glucose tolerance: acetylsalicylic acid or thyroxin, vitamin or mineral-based dietary supplements, and drugs to control hypertension or osteoporosis are acceptable
* No allergies to the foods in the test-meals and ad libitum meal
* No abusive alcohol consumption
* No intensive exercising habits
* No participation in a clinical study within the previous 6 months
* To enjoy the foods in the test-meals and ad libitum meals
* To be affiliated to a social security system
* To be available to participate in study sessions
* To have read and signed the Informed consent form
Additional criteria for Part 2
* Male
* Ability to be in an MRI scan without moving
* Ability to hold breath for 25s (a requirement for certain MRI exams)
Non-inclusion criteria:
* History of diabetes, use of antihyperglycemic drugs or insulin to treat diabetes or associated conditions
* Major medical interventions or surgeries requiring hospitalization within the previous 3 months
* Any medical condition that affects digestion and/or nutrient absorption
* Use of steroids, protease inhibitors and/or antipsychotic drugs
* Use of anticoagulation drugs
* To be participating in another clinical trial, or to be within the exclusion period of a previous clinical trial
* To have started or stopped smoking within the previous 3 months
Additional exclusion criteria for Part 2:
* Any contraindications to an MRI exam: claustrophobia, tatoos, presence of ferromagnetic elements, having a pacemaker, metallic prosthesis, cochlear implants, vascular clips, insulin pumps
* Any condition or disease that might affect the results of MRI exams.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03265392
Study Brief:
Protocol Section:
NCT03265392