Status:
RECRUITING
Effects of Distinct Nebraska-Dry Bean Market Classes on Gut Microbiota
Lead Sponsor:
University of Nebraska Lincoln
Conditions:
Dietary Intervention
Gut Microbiota
Eligibility:
All Genders
19-50 years
Phase:
NA
Brief Summary
Beans are well known for their health benefits. Many of these benefits relate to gut health, as many of the nutrients found in beans support beneficial microbes that live in the gut. However, beans ha...
Detailed Description
Bean consumption delivers diverse dietary fibers (resistant starches, non-starch polysaccharides), proteins, polyphenols, and other compounds to the colon, where they serve as substrates for the micro...
Eligibility Criteria
Inclusion
- Aged 19 to 50 years.
- Not currently pregnant or planning to become pregnant (Females Only).
- Stable body mass index (BMI) of either 18.5-24.9 kg/m2 or 27.0-39.9 kg/m2 for the last month.
- Has not made any major dietary changes in the last month.
- Able to read and speak English
- Requires no legally authorized representative (LAR).
- Not institutionalized (e.g., prison, psychological treatment center, etc.).
- Able to wear ambulatory blood pressure monitor and limit physical activity over a 24-hr. period.
- Have a bowel movement at least every other day.
- Able to collect and deliver stool samples to Innovation Campus within 4 hours of collection.
- No known allergies or intolerance to beans.
- Able to avoid consuming beans during the study, except for the provided beans (up to 1.5 cups/day).
Exclusion
- Has a cardiac device.
- History of organ transplant
- 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).
- Recent history of cancer (excluding skin cancer) in the last year.
- Current use of tobacco or vaping.
- Current or recent use (last 3 weeks) of digestive enzymes, laxatives, dietary fiber, prebiotic, or probiotic supplements.
- Medication or supplement regimen or dosage changed within the last 2 months or 3 weeks, respectively.
- Taken antibiotics in the last 2 months.
- Known allergies or intolerances to beans.
- BMI 18.5-24.9 kg/m2 (normoweight): Current use of oral or injectable medications for the treatment of most chronic conditions.
- 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.
Key Trial Info
Start Date :
May 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06935435
Start Date
May 8 2025
End Date
April 30 2027
Last Update
July 4 2025
Active Locations (1)
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1
Nebraska Food for Health Center
Lincoln, Nebraska, United States, 68588