N/A
Completed N=77
The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults
Source: ClinicalTrials.gov NCT04931836 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Change in Shannon Index (Unitless) — -0.20; 0.013 units on a scale
Summary
The present study is a 100-participant randomized controlled 2-arm parallel trial that employs a metagenomic approach to examine how 8 weeks of supervised moderate-intensity treadmill walking exercise (MWE) for 30-45 min 3 times/week alters the gut microbiome, serum short chain fatty acids, and the cardiometabolic profile, body weight, and body composition of individuals 30-64 years old who have overweight or obesity and have prediabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Shannon Index (Unitless) |
-0.20; 0.013 | — |
| PRIMARY Change in Serum Short Chain Fatty Acids (SCFA) |
0.19; 0.08 | — |
| SECONDARY High-density Lipoprotein Cholesterol (HDL-C) |
53.4; 51.7 | — |
| SECONDARY Triglycerides |
147.2; 142.7 | — |
| SECONDARY Fasting Insulin |
132.5; 134.8 | — |
| SECONDARY Fasting Glucose |
105.0; 105.0 | — |
| SECONDARY C-reactive Protein (CRP) |
4.6; 4.5 | — |
| SECONDARY Resting Systolic Blood Pressure (BP) |
121; 120 | — |
| SECONDARY Body Composition |
43.5; 43.6 | — |
| SECONDARY Cardiometabolic Risk Score (CMR) |
-.01; -.04 | — |
Eligibility Criteria
Inclusion Criteria
- Classified as overweight or obese with BMI 25.0-39.9 kg/m2.
- Documentation* of a prediabetes diagnosis within one year of enrollment by physician or primary care provider based on lab tests showing a fasted blood glucose of 100-125 mg/dL, a 2-hour oral glucose tolerance test of 140-199 mg/dL, or an HbA1c level of 5.7%-6.4%76; OR a study screening lab value of HbA1C within the afore mentioned range.
- Currently engaged in <100 min/week of physical activity - confirmed by questionnaire.
- No exercise contraindications as assessed by the Physical Activity Readiness Questionnaire (PAR-Q)78-this Questionnaire involves seven "yes" or "no" questions regarding an individual's health status, with answering "yes" to any one of these questions requiring a prospective participant to acquire a written doctor's note stating they can safely participate in the trial's exercise intervention.
- No self-reported physical/mental disabilities or gastrointestinal conditions.
- No antibiotic usage within the last 45 days.
- Stable weight over the last 6 months (<10% change).
- Not currently pregnant, planning to become pregnant, or currently breastfeeding.
- Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
- Note: Documentation can include either a print out or screen shot of the lab value illustrating eligibility, along with the date of the test and the participant's name. If a hard copy is provided, the date and name will be redacted.
Exclusion Criteria
- Self-reported use of metformin and/or other medications that could interfere with the primary outcome.
- History of bariatric surgery or a history of other medical interventions that would interfere with the primary outcome.
Data sourced from ClinicalTrials.gov (NCT04931836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.