NCT06023940: TRIUMPH

Variability in Microbial Response to Dietary Fiber

Completed NA Last updated 24 July 2024

What this trial tests

NA trial testing High fiber in Microbial Colonization in 30 participants. Completed in 31 October 2023.

Timeline

12 May 2022

Primary endpoint
31 October 2023

31 October 2023

Quick facts

Lead sponsor	University of Missouri-Columbia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	12 May 2022
Primary completion	31 October 2023
Estimated completion	31 October 2023
Sites	1 location across United States

Drugs / interventions tested

• High fiber

Conditions studied

• Microbial Colonization — all drugs for Microbial Colonization →

Sponsor

University of Missouri-Columbia

Who can join

Adults 45 to 65, any sex, with Microbial Colonization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to understand varying in responses to different dietary patterns in healthy people who are getting a health screening colonoscopy.

The main questions it aims to answer are:

* What is the variability in the change of the microbes in the gut of (1) a provided diet that is high in fiber vs (2) a diet of the participant's choice.
* What is the magnitude of fasting changes in glucose and lipids following the short-term, high-fiber feeding period and identify candidate predictive factors (short-chain fatty acids, BMI, sex, starting glucose level) for these changes

Participants will be in one of two groups:

1. High-fiber diet group: These participants will have a series of measurements that include: blood biochemistries, body composition measured via DEXA, anthropometrics, surveys and questionnaires, and collection of fecal samples.
2. Normal diet group: These participants will eat a diet that is of their choosing (ad libitum) and will have a series of measurements that include: fecal samples, and questionnaires/surveys including food records.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Repopulation of the gut microbiota after a screening colonoscopy.
   Ghouri YA, Ericsson AC, Anderson JM, George JG, et al · · 2025 · PMID 40938872 · DOI 10.1371/journal.pone.0320712