Impact of Dietary Intervention on Inflammation and Microbiome Composition Post-Colonoscopy

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06603519
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Modified Plant-Based Mediterranean Diet — DIETARY_SUPPLEMENT
    Two-week dietary intervention after the participants' scheduled colonoscopy consisting of vegetarian high-fiber meals. These meals are designed to provide a substantial intake of dietary fiber through a variety of plant-based foods, including whole grains, legumes, fruits, vegetables, nuts, and seeds. Meals will be delivered bi-weekly, and compliance will be monitored through regular check-ins with a study dietitian.

Study Details

This study aims to investigate the impact of various healthy diets, specifically a modified plant-based Mediterranean diet, on the gut microbiome and overall well-being post-colonoscopy. The investigators hypothesize that certain diets can positively influence gut bacteria, reducing inflammation and enhancing metabolic signals. To explore this, they will utilize metagenomic testing on stool samples to analyze the DNA of gut microorganisms. Additionally, they will conduct immune profiling on serum samples and perform metabolomic analysis to comprehensively evaluate the diet-induced changes in immune response and metabolic pathways. This multi-faceted approach will help them understand how dietary changes affect the composition and function of the gut microbiome, immune function, and overall metabolism.

Key Dates

Start date
Mar 4, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Dietary Intervention Group
    Participants in this arm will follow a modified plant-based Mediterranean diet following their colonoscopies. The dietary intervention aims to reduce inflammation and improve gut microbiome composition. Participants' gut bacteria and overall health will be monitored through blood and stool sample collections, focusing on inflammation reduction and metabolic health improvement.

Primary Outcome Measure

Changes in Inflammatory Markers and Microbial Metabolites [ Time Frame: 4 time-points throughout the study: Weeks 1, 4, 6, and 8 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San Diego Altman Clinical and Translational Research InstituteSan DiegoCalifornia92037-

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By condition
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By specialty
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By research site
University of California, San Diego Altman Clinical and Translational Research Institute· San Diego, CA

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