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

Summary

Overview: You are invited to participate in a research study. You can join if you are a woman, 18-40 years old, have a BMI \>25, and a regular menstrual cycle (every 24 to 38 days, per the Cleveland Clinic). This study is open to the TCU and non-TCU communities. You cannot join if you:

* Have diagnosis of diabetes or take insulin or metformin.
* Have either diagnosis of high blood pressure, is currently taking high blood pressure medications, or shows high blood pressure readings during visit 1 ≥130/80 mmHg.
* For the past month, have engaged in \>150 min/week of moderate intensity aerobic exercise (brisk walking), \>75 min/week of vigorous-intensity aerobic activity (running, fast cycling), and ≥1 session/week of strength exercising using weights for the past month.
* Have lost or gained 10% or more of your body weight in the past 3 months.
* Have used antibiotics or probiotics in the past 3 months.
* Follow a restrictive diet like vegetarian, vegan, keto, or carnivore.
* Take weight loss medications or supplements.
* Smoke (including vaping) or drink heavily (more than 8 drinks per week for women, per CDC guidelines).

Study Details: This study is being conducted at Texas Christian University, Richel building 256 and 259. The project is sponsored by a Texas Christian University Invests in Scholarship grant. The purpose of this study is to looks at how gut bacteria affect exercise benefits. We want to see if a supplement called butyrate can help people who don't get better insulin response from exercise. Butyrate is a natural substance made by gut bacteria when they break down fiber in your diet. The study lasts 12 weeks, including a 12-week supervised exercise program (30-60 min per day/5 days per week), 4 weeks of taking a butyrate supplement daily (weeks 8 to 12), 3 material pick up visits (10 min each) and 3 lab visits (60 min each). All participants will follow the 12-week exercise intervention and all participants will follow the 4-week supplementation.

Participants: You are being asked to take part because you're a woman aged 18-40 with a BMI of 25.0 or higher and have regular menstrual cycle (every 24 to 38 days, per the Cleveland Clinic). You must not have done regular exercise (less than 150 minutes of moderate activity, 75 minutes of intense activity, or 1 session of strength training per week) for the past month and have no recent competitive sports experience. If you decide to be in this study, you will be one of 40 participants in this research study at TCU.

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

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-18

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• United States

Study Locations