Obesity &Amp; OverweightNCT07180446
Can Gut Bacteria Predict Who Benefits Most From Exercise? A Gut Supplement to Help Exercise Non-Responders
A study testing Cardiovascular Exercise and Butyrate in people with Obesity &Amp; Overweight, run by Texas Christian University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Obesity &Amp; Overweight
- What is being tested?
- Cardiovascular Exercise and Butyrate
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting Exercise-Induced Insulin Sensitivity With AI: Butyrate Supplementation as a Therapy for Exercise-Resistant Individuals
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).
Read more
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.
Read the detailed description
This is a single-arm, interventional study investigating the role of the gut microbiome in mediating the effects of cardiovascular exercise on insulin sensitivity in adult females with overweight or obesity (BMI ≥25). The study also evaluates the effectiveness of sodium butyrate supplementation in enhancing insulin sensitivity among individuals who are otherwise non-responsive to exercise alone.
The study will enroll 40 female participants between the ages of 18 and 40, who have been sedentary for at least six months. Exclusion criteria include a diagnosis of diabetes or hypertension, recent weight changes, use of antibiotics, probiotics, or weight loss supplements, and any condition contraindicating safe participation in exercise.
Participants will engage in a 12-week supervised cardiovascular exercise program at the TCU Recreation Center. Exercise will progress from 30 to 60 minutes per session, 5 days per week, with intensity increasing from 50% to 80% of estimated maximum heart rate. During weeks 8 through 12, participants will take sodium butyrate (BodyBio; 939 mg sodium/day) in capsule form, dosed at 2 capsules with each meal (6 total/day).
Data collection includes:
- Stool samples (3 total): collected pre-intervention, at week 8 (pre-supplementation), and at week 12 (post-supplementation), to evaluate changes in gut microbial composition and diversity.
- Blood samples (3 total): fasting blood draws at the same three time points to measure glucose and insulin for calculation of HOMA-IR and other insulin sensitivity indices.
- Body composition: assessed at three time points using Dual-Energy X-ray Absorptiometry (DEXA) to determine fat mass, lean mass, and bone mineral density.
- Questionnaires: validated instruments assessing physical activity, dietary intake, sleep, anxiety, depression, and food cravings.
- Blood pressure: at the beginning of the study, and every week during the supplementation phase
The primary outcomes include changes in insulin sensitivity and gut microbiota composition across the 12-week intervention. Secondary outcomes include body composition changes and the classification of participants as "responders" or "non-responders" to exercise based on insulin sensitivity improvements.
An exploratory objective is to develop predictive models using AI algorithms (e.g., decision trees, random forests, support vector machines, logistic regression) trained on baseline gut microbiota and blood biomarkers to predict individual response to exercise.
This study is internally funded by a TCU Innovation Scholars (IS) Grant (~$20,000), with an in-kind supplement donation valued at $2,000 provided by BodyBio. The study is conducted entirely on the TCU campus and has been approved by the TCU Institutional Review Board (IRB #2025-217). Results from this study aim to advance personalized exercise strategies and contribute to the growing field of precision medicine.
- Conditions
- Obesity &Amp; Overweight
- Being tested
- Cardiovascular Exercise, Butyrate
- Keywords
- Butyrate, Gut Microbiome, Exercise, Cardiovascular, Insulin, Gut Microbiota
- Medical subject headings
- Obesity, Overweight, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular ExerciseBehavioural
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.
ButyrateDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Participants will undergo a 12-week exercise intervention. During the final 4 weeks, they will additionally receive sodium butyrate supplementation. The model uses repeated measures to assess changes in insulin sensitivity, gut microbiome composition, and body composition before and after the intervention. Receives: Behavioral: Cardiovascular Exercise; Dietary Supplement: Butyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin Sensitivity (HOMA-IR)
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.
Measured: Measured at Baseline (Week 0), Week 8 (pre-supplementation), and Week 12 (post-supplementation)
Secondary outcomes (6)
Alpha Diversity
16S rRNA sequencing of stool samples will be used to evaluate changes in gut microbial alpha diversity in response to exercise and butyrate supplementation.
Measured: Collected at Baseline (Week 0), Week 8, and Week 12
Lean Mass
Dual-Energy X-ray Absorptiometry (DEXA) will assess changes in total lean mass (kg)
Measured: Measured at Baseline (Week 0), Week 8, and Week 12
Bone mineral density
DEXA will be used to measure bone mineral density (g/cm2)
Measured: Measured at Baseline (Week 0), Week 8, and Week 12
Fat Mass
Dexa will be used to measure total fat mass (kg)
Measured: Measured at Baseline (Week 0), Week 8, and Week 12
Beta diversity
16S rRNA sequencing of stool samples will be used to evaluate changes in gut microbial beta diversity in response to exercise and butyrate supplementation.
Measured: Measured at Baseline (Week 0), Week 8, and Week 12
Taxonomic Classification
16S rRNA sequencing of stool samples will be used to evaluate changes in gut microbial taxonomic composition in response to exercise and butyrate supplementation.
Measured: Measured at Baseline (Week 0), Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start18 Jan 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obesity &Amp; OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional Study Model: Type: Interventional (Clinical Trial) Design: Single-group assignment (one-arm study) Model: Pretest-Posttest Design Allocation: Non-randomized Masking: None (Open Label) Primary Purpose: Treatment / Mechanistic Time Perspective: Prospective Study Duration: 12 weeks Intervention Type: Behavioral: Supervised cardiovascular exercise (progressively increasing intensity over 12 weeks) Dietary Supplement: Sodium butyrate (oral capsules, 6 per day, taken during weeks 8-12) Description: Participants will undergo a 12-week exercise intervention. During the final 4 weeks, they will additionally receive sodium butyrate supplementation. The model uses repeated measures to assess changes in insulin sensitivity, gut microbiome composition, and body composition before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Marroquin, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180446
- Sponsor's protocol ID
- Exercise - Gut Microbiome
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to conduct additional analyses using the samples and data collected in this study beyond the primary aims described in this trial. However, if no further use is identified after the study and initial data analysis are complete, individuals may request information about data sharing by contacting Dr. Elisa Marroquín.
Publications
Noone J, Mucinski JM, DeLany JP, Sparks LM, Goodpaster BH. Understanding the variation in exercise responses to guide personalized physical activity prescriptions. Cell Metab. 2024 Apr 2;36(4):702-724. doi: 10.1016/j.cmet.2023.12.025. Epub 2024 Jan 22.
PubMed 38262420Cleophas MCP, Ratter JM, Bekkering S, Quintin J, Schraa K, Stroes ES, Netea MG, Joosten LAB. Effects of oral butyrate supplementation on inflammatory potential of circulating peripheral blood mononuclear cells in healthy and obese males. Sci Rep. 2019 Jan 28;9(1):775. doi: 10.1038/s41598-018-37246-7.
PubMed 30692581Krauze W, Busz N, Pikula W, Maternowska M, Prowans P, Maciejewska-Markiewicz D. Effect of Sodium Butyrate Supplementation on Type 2 Diabetes-Literature Review. Nutrients. 2025 May 22;17(11):1753. doi: 10.3390/nu17111753.
PubMed 40507022Liu Y, Wang Y, Ni Y, Cheung CKY, Lam KSL, Wang Y, Xia Z, Ye D, Guo J, Tse MA, Panagiotou G, Xu A. Gut Microbiome Fermentation Determines the Efficacy of Exercise for Diabetes Prevention. Cell Metab. 2020 Jan 7;31(1):77-91.e5. doi: 10.1016/j.cmet.2019.11.001. Epub 2019 Nov 27.
PubMed 31786155Boule NG, Weisnagel SJ, Lakka TA, Tremblay A, Bergman RN, Rankinen T, Leon AS, Skinner JS, Wilmore JH, Rao DC, Bouchard C; HERITAGE Family Study. Effects of exercise training on glucose homeostasis: the HERITAGE Family Study. Diabetes Care. 2005 Jan;28(1):108-14. doi: 10.2337/diacare.28.1.108.
PubMed 15616242Bohm A, Weigert C, Staiger H, Haring HU. Exercise and diabetes: relevance and causes for response variability. Endocrine. 2016 Mar;51(3):390-401. doi: 10.1007/s12020-015-0792-6. Epub 2015 Dec 7.
PubMed 26643313
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Exercise-Induced Insulin Sensitivity With AI: Butyrate Supplementation as a Therapy for Exercise-Resistant Individuals
- ClinicalTrials.gov ID
- NCT07180446
- Acronym / sponsor ID
- Exercise - Gut Microbiome
- Conditions
- Obesity &Amp; Overweight
- Keywords
- Butyrate, Gut Microbiome, Exercise, Cardiovascular, Insulin, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- 18 Jan 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-arm, interventional study investigating the role of the gut microbiome in mediating the effects of cardiovascular exercise on insulin sensitivity in adult females with overweight or obesity (BMI ≥25). The study also evaluates the effectiveness of sodium butyrate supplementation in enhancing insulin sensitivity among individuals who are otherwise non-responsive to exercise alone.
The study will enroll 40 female participants between the ages of 18 and 40, who have been sedentary for at least six months. Exclusion criteria include a diagnosis of diabetes or hypertension, recent weight changes, use of antibiotics, probiotics, or weight loss supplements, and any condition contraindicating safe participation in exercise.
Participants will engage in a 12-week supervised cardiovascular exercise program at the TCU Recreation Center. Exercise will progress from 30 to 60 minutes per session, 5 days per week, with intensity increasing from 50% to 80% of estimated maximum heart rate. During weeks 8 through 12, participants will take sodium butyrate (BodyBio; 939 mg sodium/day) in capsule form, dosed at 2 capsules with each meal (6 total/day).
Data collection includes:
- Stool samples (3 total): collected pre-intervention, at week 8 (pre-supplementation), and at week 12 (post-supplementation), to evaluate changes in gut microbial composition and diversity.
- Blood samples (3 total): fasting blood draws at the same three time points to measure glucose and insulin for calculation of HOMA-IR and other insulin sensitivity indices.
- Body composition: assessed at three time points using Dual-Energy X-ray Absorptiometry (DEXA) to determine fat mass, lean mass, and bone mineral density.
- Questionnaires: validated instruments assessing physical activity, dietary intake, sleep, anxiety, depression, and food cravings.
- Blood pressure: at the beginning of the study, and every week during the supplementation phase
The primary outcomes include changes in insulin sensitivity and gut microbiota composition across the 12-week intervention. Secondary outcomes include body composition changes and the classification of participants as "responders" or "non-responders" to exercise based on insulin sensitivity improvements.
An exploratory objective is to develop predictive models using AI algorithms (e.g., decision trees, random forests, support vector machines, logistic regression) trained on baseline gut microbiota and blood biomarkers to predict individual response to exercise.
This study is internally funded by a TCU Innovation Scholars (IS) Grant (~$20,000), with an in-kind supplement donation valued at $2,000 provided by BodyBio. The study is conducted entirely on the TCU campus and has been approved by the TCU Institutional Review Board (IRB #2025-217). Results from this study aim to advance personalized exercise strategies and contribute to the growing field of precision medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional Study Model: Type: Interventional (Clinical Trial) Design: Single-group assignment (one-arm study) Model: Pretest-Posttest Design Allocation: Non-randomized Masking: None (Open Label) Primary Purpose: Treatment / Mechanistic Time Perspective: Prospective Study Duration: 12 weeks Intervention Type: Behavioral: Supervised cardiovascular exercise (progressively increasing intensity over 12 weeks) Dietary Supplement: Sodium butyrate (oral capsules, 6 per day, taken during weeks 8-12) Description: Participants will undergo a 12-week exercise intervention. During the final 4 weeks, they will additionally receive sodium butyrate supplementation. The model uses repeated measures to assess changes in insulin sensitivity, gut microbiome composition, and body composition before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Cardiovascular Exercise, Dietary Supplement: ButyrateParticipants will undergo a 12-week exercise intervention. During the final 4 weeks, they will additionally receive sodium butyrate supplementation. The model uses repeated measures to assess changes in insulin sensitivity, gut microbiome composition, and body composition before and after the intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular ExerciseParticipants 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. | Behavioural | Exercise |
| ButyrateParticipants 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. | Dietary supplement | Exercise |
Primary outcome
Change in Insulin Sensitivity (HOMA-IR)
Time frame: 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.
6 secondary outcomes
Alpha Diversity
Time frame: Collected at Baseline (Week 0), Week 8, and Week 12
Lean Mass
Time frame: Measured at Baseline (Week 0), Week 8, and Week 12
Bone mineral density
Time frame: Measured at Baseline (Week 0), Week 8, and Week 12
Fat Mass
Time frame: Measured at Baseline (Week 0), Week 8, and Week 12
Beta diversity
Time frame: Measured at Baseline (Week 0), Week 8, and Week 12
Taxonomic Classification
Time frame: Measured at Baseline (Week 0), Week 8, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 38262420Noone J, Mucinski JM, DeLany JP, Sparks LM, Goodpaster BH. Understanding the variation in exercise responses to guide personalized physical activity prescriptions. Cell Metab. 2024 Apr 2;36(4):702-724. doi: 10.1016/j.cmet.2023.12.025. Epub 2024 Jan 22.
- Background: PubMed 30692581Cleophas MCP, Ratter JM, Bekkering S, Quintin J, Schraa K, Stroes ES, Netea MG, Joosten LAB. Effects of oral butyrate supplementation on inflammatory potential of circulating peripheral blood mononuclear cells in healthy and obese males. Sci Rep. 2019 Jan 28;9(1):775. doi: 10.1038/s41598-018-37246-7.
- Background: PubMed 40507022Krauze W, Busz N, Pikula W, Maternowska M, Prowans P, Maciejewska-Markiewicz D. Effect of Sodium Butyrate Supplementation on Type 2 Diabetes-Literature Review. Nutrients. 2025 May 22;17(11):1753. doi: 10.3390/nu17111753.
- Background: PubMed 31786155Liu Y, Wang Y, Ni Y, Cheung CKY, Lam KSL, Wang Y, Xia Z, Ye D, Guo J, Tse MA, Panagiotou G, Xu A. Gut Microbiome Fermentation Determines the Efficacy of Exercise for Diabetes Prevention. Cell Metab. 2020 Jan 7;31(1):77-91.e5. doi: 10.1016/j.cmet.2019.11.001. Epub 2019 Nov 27.
- Background: PubMed 15616242Boule NG, Weisnagel SJ, Lakka TA, Tremblay A, Bergman RN, Rankinen T, Leon AS, Skinner JS, Wilmore JH, Rao DC, Bouchard C; HERITAGE Family Study. Effects of exercise training on glucose homeostasis: the HERITAGE Family Study. Diabetes Care. 2005 Jan;28(1):108-14. doi: 10.2337/diacare.28.1.108.
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- Individual participant dataSharing planned: No. We plan to conduct additional analyses using the samples and data collected in this study beyond the primary aims described in this trial. However, if no further use is identified after the study and initial data analysis are complete, individuals may request information about data sharing by contacting Dr. Elisa Marroquín.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular Exercise and Butyrate in people with Obesity &Amp; Overweight, run by Texas Christian University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insulin Sensitivity (HOMA-IR) (time frame: Measured at Baseline (Week 0), Week 8 (pre-supplementation), and Week 12 (post-supplementation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07180446, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.