Clinical Trial

Pulses Consumption and Its Role in Managing Systemic Inflammation, Insulin Sensitivity and Gut Microbiome in Human

Study acronym: PS
Active, Not Recruiting
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Summary
Objective 1: Characterize indices of systemic inflammation and gut microbiota composition and function after chronic (12 weeks) intake of pulses compared to control diet in human OW/OB-IR participants. Objective 2: Characterize dietary- and microbial-derived metabolite pools after regular intake of pulses (12 weeks) in human participants with OW/OB-IR compared to control diet. Objective 3: Characterize cognitive functioning after chronic (12 weeks) intake of pulses compared to control diet in human OW/OB-IR participants.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2020-02-10; most recent amendment 2025-05-07.
Status change: Recruiting → Active, Not Recruiting 2023-05-02
Status change: Active, Not Recruiting → Recruiting 2021-04-14
Status change: Not Yet Recruiting → Active, Not Recruiting 2020-07-13
Trial Details
NCT Number NCT04267705
Lead Sponsor Clinical Nutrition Research Center, Illinois Institute of Technology
Collaborators: USDA Beltsville Human Nutrition Research Center
Conditions Insulin Sensitivity, Overweight or Obesity, Inflammatory Response
Enrollment 103 participants
Start Date 2020-02-24
Primary Completion 2023-05-30 (estimated)
Study Completion 2026-01-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-08