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 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT06971666
Eligibility Criteria:
Inclusion Criteria:
* Both sexes with no gender exclusion
* Age between 18 and 24 years
* Body Mass Index (BMI) ≥ 30 kg/m²
* Signed informed consent
Exclusion Criteria:
* Pregnancy or expected pregnancy within the next month
* Women who are breastfeeding
* Diagnosed conditions such as: diabetes mellitus, hypertension, renal or hepatic insufficiency, infectious diseases, inflammatory diseases, or any neoplastic disease
* Conditions with dietary restrictions, such as celiac disease or history of gastric bypass surgery
* Active alcoholism with a daily intake exceeding 50 g/day
* Significant anticipated changes in diet or exercise within 15 days prior to the study's start
* History of drug or medication abuse
* Eating disorders
* Participation in any study involving investigational products within the 3 months prior to the start of the study
* Treatment with anti-inflammatory drugs, antibiotics, and/or antidepressants in the month prior to the study's start
* Consumption of nutraceuticals containing prebiotics, probiotics, or immunomodulators within 15 days prior to the study's start
* Individuals who choose to discontinue participation after the data collection process has started.
* Individuals who do not consent to the collection of any of the required samples (blood, diet, or stool) during the data collection phase.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
24 Years
Study:
NCT06971666
Study Brief:
Protocol Section:
NCT06971666