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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT02656056
Eligibility Criteria:
Inclusion Criteria:
* Adults (aged between 18 and 70) that are obese (BMI 32-37) (n=10)
* Adults (aged between 18 and 70) that are lean (BMI 21-25) (n=10)
Exclusion Criteria:
* Allergy to soy or soy derivatives.
* Patients will be excluded if they had abdominal surgeries (excluding cholecystectomy, appendectomy, hysterectomy, and hernia repair).
* History of inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) and/or gastrointestinal bleeding.
* Medications: Antibiotics, probiotics, or systemic corticosteroids (within 6 months of enrollment).
* Radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function.
* Patients will be excluded if using medications which are known to be affected by modest dietary changes. This will include, but is not limited to, warfarin and immunosuppressives such as cyclosporin.
* Alcohol use disorder, anorexia nervosa, autoimmune disease, bulimia, celiac disease, chronic infections, and illicit drug use.
* Major changes in dietary habits in past six months.
* Pregnancy or intent to get pregnant during study period
* Use of tobacco, including cigarettes, smokeless tobacco, cigars, and pipes within 30 days of enrollment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02656056
Study Brief:
Protocol Section:
NCT02656056