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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT05493592
Eligibility Criteria:
Inclusion Criteria:
* Have a BMI ≥ 35 kg/m² (severely obese)
* Ability, at the time of inclusion, to follow a personalized physical activity program for 24 weeks.
* Have agreed to follow-up for up to 36 weeks
* Be affiliated to a social security system
* Be able to freely give informed consent (oral)
Exclusion Criteria:
* Pregnant woman
* Have a history of type 1 diabetes
* Weight \>150 kg (criterion related to the capacity of the exercise bikes used in the study)
* History of renal disease \[glomerular filtration \< 30 mL/min\], cardiovascular history of myocardial ischemia (ECG signs), uncontrolled hypertension \[at rest; systolic blood pressure \> 140 mm Hg and diastolic blood pressure \> 90 mm Hg\], heart failure, cardiac valvulopathy, peripheral arterial disease or arteritis, and stroke.
* Have an auto-inflammatory or autoimmune pathology known to modify the expression of NLRP3 (cryopyrinopathies, Crohn's disease, gouty arthritis, chondrocalcinosis, arthritic diseases, type 1 diabetes, Biermer's disease, Basedow's disease, rheumatoid arthritis, systemic lupus erythematosus, sclerodermias, non-alcoholic liver steatosis, multiple sclerosis, Alzheimer's and Parkinson's diseases)
* Have a history of recent (\<6 months) infectious disease of viral, parasitic, fungal or bacterial origin known to modify the expression of NLRP3
* Taking medication that may affect weight gain (systemic corticosteroids, psychotropic drugs, migraine medications, beta-blockers, chemotherapy, and antibiotics)
* Have completed a personalized physical activity program in the 12 weeks prior to inclusion,
* Have bariatric surgery scheduled within 6 months of inclusion,
* Have a known intolerance to legume seeds
* Have an unbalanced low-calorie diet
* Have consumed dietary supplements containing polyphenols of the flavonoid class (green tea catechins and isoflavones from soy and legume seeds in the 3 months prior to inclusion).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05493592
Study Brief:
Protocol Section:
NCT05493592