Gut bacteria booster may unlock exercise benefits for some women

NCT ID NCT07180446

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a natural supplement called butyrate can improve how the body responds to exercise in women with overweight or obesity. Participants will follow a 12-week exercise program and take butyrate daily for the last 4 weeks. The goal is to see if this helps those who don't normally get better insulin sensitivity from exercise alone.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Insulin Resistance Motor Activity Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Texas Christian University

    Fort Worth, Texas, 76008, United States

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Other studies related to the condition(s) this trial covers.