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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Jun 30, 2026 → Apr 30, 2027
See other at-risk trials from Texas Christian University

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Jun 30, 2026 to Apr 30, 2027 Show 4 more changesShow less
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Publications: details revised at 6 of 6 entries
    • Study description expanded, about 5 words
  2. Notable Enrollment target: 25 to 40v2 Show 6 more changesShow less
    • Start date changed from estimate of Sep 18, 2025 to Jan 18, 2026
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Aug 10, 2026 to Jun 30, 2026
    • Eligibility criteria expanded, about 497 words
    • Site contact updated
    • Study description expanded, about 4 words
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07180446
Lead Sponsor Texas Christian University
Conditions
(from sponsor)
Obesity & Overweight
Related terms Insulin Resistance, Motor Activity, Obesity, Overweight
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov