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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT06935435
Eligibility Criteria:
Inclusion Criteria:
1. Aged 19 to 50 years.
2. Not currently pregnant or planning to become pregnant (Females Only).
3. Stable body mass index (BMI) of either 18.5-24.9 kg/m2 or 27.0-39.9 kg/m2 for the last month.
4. Has not made any major dietary changes in the last month.
5. Able to read and speak English
6. Requires no legally authorized representative (LAR).
7. Not institutionalized (e.g., prison, psychological treatment center, etc.).
8. Able to wear ambulatory blood pressure monitor and limit physical activity over a 24-hr. period.
9. Have a bowel movement at least every other day.
10. Able to collect and deliver stool samples to Innovation Campus within 4 hours of collection.
11. No known allergies or intolerance to beans.
12. Able to avoid consuming beans during the study, except for the provided beans (up to 1.5 cups/day).
Exclusion Criteria:
1. Has a cardiac device.
2. History of organ transplant
3. History of gastrointestinal surgery or disease diagnosed by a physician that involves the stomach, small, and large intestines (e.g., IBD, IBS, chronic constipation, diverticulosis, gastric bypass).
4. Recent history of cancer (excluding skin cancer) in the last year.
5. Current use of tobacco or vaping.
6. Current or recent use (last 3 weeks) of digestive enzymes, laxatives, dietary fiber, prebiotic, or probiotic supplements.
7. Medication or supplement regimen or dosage changed within the last 2 months or 3 weeks, respectively.
8. Taken antibiotics in the last 2 months.
9. Known allergies or intolerances to beans.
10. BMI 18.5-24.9 kg/m2 (normoweight): Current use of oral or injectable medications for the treatment of most chronic conditions.
11. BMI 27.0-39.9 kg/m2 (overweight): Current use of oral or injectable medications for the treatment of diabetes, hypertension, cardiovascular, liver, kidney, gastrointestinal, or autoimmune.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
50 Years
Study:
NCT06935435
Study Brief:
Protocol Section:
NCT06935435