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Can Gut Bacteria Predict Who Benefits Most From Exercise? A Gut Supplement to Help Exercise Non-Responders

NCT07180446 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-09-18

No results posted yet for this study

Summary

The goal of this clinical trial is to learn how gut bacteria affect the way the body responds to exercise, especially how the body uses insulin. It also aims to learn if a supplement called sodium butyrate can help people who don't respond well to exercise alone.

The main questions it aims to answer are:

* Does exercise improve how the body uses insulin in male participants who have overweight or obesity?
* Can gut bacteria predict who will benefit most from exercise?
* Does sodium butyrate help improve insulin response in people who don't respond to exercise alone?

Participants will:

* Exercise 5 days a week for 12 weeks under supervision
* Take sodium butyrate (a natural gut health supplement) daily for the last 4 weeks of the program
* Provide blood and stool samples at three points during the study
* Complete health and lifestyle questionnaires
* Get body composition scans (DEXA) before, during, and after the study

This study may help researchers find new ways to personalize exercise plans based on gut health and improve blood sugar control.

Conditions

  • Obesity &Amp; Overweight

Interventions

BEHAVIORAL

Cardiovascular Exercise

Participants will complete a 12-week supervised cardiovascular exercise program at the TCU Recreation Center. Exercise will occur 5 days per week, beginning with 30 minutes per session and progressing to 60 minutes. Intensity will start at 50% of estimated maximal heart rate and gradually increase to 80% by week 8, remaining at that level through week 12. Exercise modalities may include treadmill walking/running, rowing, elliptical, or cycling, based on participant preference and fitness level. Certified trainers will supervise all sessions to ensure safety, proper technique, and adherence to the intensity targets. Participants will wear ActiGraph heart rate monitors to verify exercise intensity throughout the intervention.

DIETARY_SUPPLEMENT

Butyrate

Participants will take a dietary supplement containing sodium butyrate during the final 4 weeks (weeks 8-12) of the 12-week intervention. The supplement will be provided in capsule form, with participants instructed to take six capsules per day-two with each meal. This daily dose is equivalent to 3.6 g of butyric acid, which provides 939 mg of sodium, delivered as sodium butyrate. The supplement is intended to support gut health and potentially enhance insulin sensitivity in individuals who do not respond to exercise alone. Participants will receive a 4-week supply during their 8-week study visit, along with instructions for proper use and monitoring of any side effects.

Sponsors & Collaborators

  • Texas Christian University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-18
Primary Completion
2026-08-10
Completion
2026-08-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07180446 on ClinicalTrials.gov