Predicting Exercise-Induced Insulin Sensitivity With AI: Butyrate Supplementation as a Therapy for Exercise-Resistant Individuals
Texas Christian University
Summary
The goal of this clinical trial is to learn how gut bacteria affect the way the body responds to exercise, especially how the body uses insulin. It also aims to learn if a supplement called sodium butyrate can help people who don't respond well to exercise alone. The main questions it aims to answer are: * Does exercise improve how the body uses insulin in male participants who have overweight or obesity? * Can gut bacteria predict who will benefit most from exercise? * Does sodium butyrate help improve insulin response in people who don't respond to exercise alone? Participants will: * Exercise 5 days a week for 12 weeks under supervision * Take sodium butyrate (a natural gut health supplement) daily for the last 4 weeks of the program * Provide blood and stool samples at three points during the study * Complete health and lifestyle questionnaires * Get body composition scans (DEXA) before, during, and after the study This study may help researchers find new ways to personalize exercise plans based on gut health and improve blood sugar control.
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 males 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 25 male participants between the ages of 18 and 40, who are affiliated with Texas Christian University (students, staff, or faculty) and have been sedentary for at least six months…
Eligibility
- Age range
- 18–40 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Male, aged 18 to 40 years * BMI ≥ 25.0 kg/m² (classified as overweight or obese) * Affiliated with TCU (student, staff, or faculty) * Sedentary lifestyle, defined as: * Less than 150 minutes/week of moderate-intensity aerobic activity * Less than 75 minutes/week of vigorous-intensity activity * Fewer than 1 strength training session/week over the past 6 months * Willingness to maintain current diet throughout the study * Able and willing to understand and complete forms in English * Able to provide informed consent Exclusion Criteria: * Diagnosis of diabetes or current…
Interventions
- BehavioralCardiovascular 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 SupplementButyrate
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.
Location
- Texas Christian UniversityFort Worth, Texas