NCT07180446
Can Gut Bacteria Predict Who Benefits Most From Exercise? A Gut Supplement to Help Exercise Non-Responders
Active, Not Recruiting
NAAges 18–40InterventionalTreatmentTexas Christian UniversityInvestigator-initiated
~40 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:Cardiovascular ExerciseButyrate
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Insulin Sensitivity (HOMA-IR)
Measured over Measured at Baseline (Week 0), Week 8 (pre-supplementation), and Week 12 (post-supplementation)
Conditions
Where it's being run
1 sites across 1 statesTexas1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
BMI greater than or equal to 25: A BMI at or greater than 25 classifies an individual as having overweight or obesity, which is the population we are looking for in this study.
Female individuals with regular menstrual cycles (every 24 to 38 days, per the Cleveland Clinic): For this pilot study, we are limiting participation to female individuals, as our sample size is insufficient to investigate sex differences in gut microbiome interactions, which our prior experience suggests are significant. The menstrual cycle is controlled for as it can affect insulin resistance values, which is one of our main outcome variables.
Age 18-40 years: Limiting the age range helps reduce age-related variability in metabolism, hormonal profiles, and gut microbiota composition. Adults under 40 are less likely to have comorbidities or take medications that could confound results. This age range also ensures participants can legally consent and likely have the cognitive capacity to understand and comply with study procedures.
Willingness to maintain current diet: Diet has a strong influence on metabolic and microbiome outcomes. Requiring participants to maintain their habitual diet reduces a major source of variability and allows for clearer attribution of observed effects to the intervention being studied
Desire/ability to understand and complete forms in English: To ensure informed consent and data accuracy, participants must be able to understand study materials, instructions, and questionnaires.
Willingness to participate in a 12-week exercise intervention.
Exclusion
Having diabetes of any kind and/or currently being prescribed insulin: Diabetes significantly alters metabolic processes and gut microbiota, which may confound the outcomes of interest. Insulin therapy can independently affect weight, glucose regulation, and inflammatory status. Excluding individuals with diabetes ensures a more metabolically uniform sample and avoids the need for complex medical monitoring
Having a diagnosis of high blood pressure, currently taking high blood pressure medications, or having high blood pressure readings during visit 1 ≥130/80 mmHg
Current participation in regular exercise or participation in the last month (\> 150 minutes of moderate activity, 75 minutes of intense activity, or more than 1 session of strength training per week): Regular physical activity affects weight, metabolism, insulin sensitivity, and gut microbiota. Including only untrained participants minimizes variability and allows a clearer assessment of the study intervention's effects without confounding from exercise-related physiological changes.
Recent significant weight change (weight loss or gain of ≥10% of body weight in the last 3 months): Substantial recent weight gain or loss may signal underlying health changes, dietary shifts, or medication use that could influence study outcomes. It also complicates baseline comparisons and longitudinal measures. Stable weight ensures physiological stability and data consistency.
Use of antibiotics or probiotics in the last 3 months: Antibiotics can drastically alter the gut microbiome for weeks to months, and probiotics may modulate microbial composition and metabolic markers. To isolate the effects of the study intervention, participants must have a stable, unaltered baseline microbiota.
Current pregnancy or planning to become pregnant during the study duration: Pregnancy induces major hormonal, metabolic, and microbiome changes, making it a strong confounder. For safety and scientific clarity, pregnant individuals are excluded to avoid complications and ensure data homogeneity.
Currently lactating: Lactation also involves significant hormonal and metabolic shifts. These physiological changes could confound outcomes related to metabolism, weight, or microbiota composition.
Following a vegetarian, vegan, keto, carnivore, intermittent fasting, inconsistent time-restricted feeding, or another restrictive diet: Restrictive diets strongly influence gut microbiota, energy metabolism, and nutrient absorption. Excluding individuals on these diets helps control for dietary variability and standardize the nutritional background of participants.
Currently taking weight loss medications (such as GLP-1 receptor agonists) or supplements: These medications and supplements can alter appetite, weight, metabolic markers, and microbiome composition. Their use could obscure the effects of the study intervention, so exclusion improves internal validity.
Smoking, vaping, or excessive alcohol use (e.g., \>14 drinks/week for men, per CDC guidelines): Tobacco and excessive alcohol use are associated with systemic inflammation, metabolic changes, and altered gut microbiota. Excluding these individuals reduces health-related confounding and protects participant safety
Inability to understand and/or complete forms in English: Accurate completion of study forms, consent, and assessments is essential for reliable data collection. If forms are only available in English, participants must be proficient to ensure informed consent and study integrity.
What this trial measures
- Change in Insulin Sensitivity (HOMA-IR)Measured at Baseline (Week 0), Week 8 (pre-supplementation), and Week 12 (post-supplementation)
Fasting blood glucose and insulin levels will be used to calculate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). This outcome will assess the impact of exercise and sodium butyrate supplementation on insulin sensitivity.