Status:
RECRUITING
Effect of Lentils and Chickpeas on Gut Microbiome and Metabolic Health
Lead Sponsor:
Florida State University
Collaborating Sponsors:
United States Department of Agriculture (USDA)
Conditions:
Dysbiosis
Eligibility:
All Genders
18-30 years
Phase:
NA
Brief Summary
The primary goal of this research is to evaluate the effect of daily whole-cooked chickpea and lentil consumption for 8-weeks on gut health, including microbiome-metabolome arrays and gut epithelial/b...
Eligibility Criteria
Inclusion
- Between 18 and 30 years old
- Ability to speak and read in English
Exclusion
- Intake of antibiotics in the last 3 months
- Intake of pre/pro/postbiotics in the last 3 months
- Current or past (within the last 6 months) user of tobacco, marijuana, or E-cigarette products
- Cardiovascular disease (heart failure, hypertension, hyper/dyslipidemia, past myocardial infarction)
- Gastrointestinal disease (ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, fistulas, suspected or known gastric strictures, gastritis, radiation enteritis, GI bleeding, gastric bezoar, recent GI surgery in the last 3 months, etc..),
- Neurological disorders (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled or insulin dependent diabetes - A1C \> 9%).
- Food allergy to study foods (pulses or soy, milk, peanuts, tree nuts)
- Regular consumption of pulses (\>1 cup/wk for males; \>0.5 cup/wk for females)
- Current heavy alcohol use (≥ 15 drinks / week for men, ≥ 8 drinks / week for women)
- Class 3 Obesity (BMI \> 40 kg/m2)
- Known to be currently pregnant (self-disclosed).
Key Trial Info
Start Date :
March 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06914375
Start Date
March 28 2025
End Date
June 30 2027
Last Update
April 6 2025
Active Locations (1)
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1
Florida State Univresity - The Gut Biome Lab
Tallahassee, Florida, United States, 32306