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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07392905
Eligibility Criteria:
Inclusion Criteria:
Obese participants:
1. BMI ≥ 28 kg/m²;
2. Age 18-40 years;
3. Any gender;
4. Right-handed.
Healthy control participants:
1. BMI 18.5-23.9 kg/m²;
2. Age 18-40 years;
3. Any gender;
4. Right-handed.
Exclusion Criteria:
1. Diabetes mellitus;
2. Contraindications or allergies to any ingredient in the standardized meal or macronutrient challenges used in this study;
3. Central nervous system disorders (e.g., traumatic brain injury, acute cerebral infarction, epilepsy) or psychiatric disorders (e.g., depression, schizophrenia); use of medications acting on the central nervous system within the past 3 months or long-term use;
4. Severe impairment of liver, kidney, heart, or gastrointestinal function, including alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels \>2 times the upper limit of normal; estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m² calculated by the CKD-EPI equation; history of unstable angina or myocardial infarction within the past 3 months, or heart failure classified as New York Heart Association (NYHA) class II or higher; history of gastrointestinal stoma, bowel resection, intestinal obstruction, or peptic ulcer disease;
5. Contraindications to MRI, such as implanted metallic devices or claustrophobia;
6. Pregnancy or lactation;
7. Participation in another clinical trial currently or within the past 3 months; use of nutritional supplements within the past 3 months or long-term use;
8. History of prior metabolic/bariatric surgery;
9. Use of antibiotics or probiotics within the past 1 month;
10. Use of medications affecting metabolism or causing weight loss within the past 1 month; body weight fluctuation exceeding 3 kg during the month prior to screening;
11. Unusual dietary habits; daily alcohol intake \>40 grams, smoking \>10 cigarettes per day, or coffee consumption ≥2 cups per day.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT07392905
Study Brief:
Protocol Section:
NCT07392905