Status:
NOT_YET_RECRUITING
Can Gut Bacteria Predict Who Benefits Most From Exercise? A Gut Supplement to Help Exercise Non-Responders
Lead Sponsor:
Texas Christian University
Conditions:
Obesity &Amp; Overweight
Eligibility:
MALE
18-40 years
Phase:
NA
Brief 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 but...
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 males with overweight or obe...
Eligibility Criteria
Inclusion
- 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
- Diagnosis of diabetes or currently prescribed insulin
- Hypertension, defined as:
- A diagnosis of high blood pressure
- Currently taking antihypertensive medication
- Blood pressure ≥130/80 mmHg during screening (Visit 1)
- Regular physical activity as defined in inclusion criteria
- Recent significant weight change (≥5% of body weight lost or gained in the past 3 months)
- Use of antibiotics or probiotics in the past 3 months
- Pregnant or planning pregnancy during the study period
- Currently lactating
- Following a restrictive diet (e.g., vegetarian, vegan, keto, carnivore)
- Taking weight loss medications or supplements (e.g., GLP-1 receptor agonists)
- Smoking or excessive alcohol use (\>14 drinks/week for men)
- Participation in another research study (clinical trial or intervention study)
- Contraindications to exercise as determined by the Physical Activity Readiness Questionnaire Plus (PARQ+)
- Inability to understand or complete forms in English
Key Trial Info
Start Date :
September 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 10 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07180446
Start Date
September 18 2025
End Date
August 10 2026
Last Update
September 18 2025
Active Locations (1)
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1
Texas Christian University
Fort Worth, Texas, United States, 76008