Trial results for a study investigating the influence of physical activity on the gut microbiome and cardiometabolic profile in adults with obesity and prediabetes were posted on ClinicalTrials.gov on 2025-06-13, with 77 participants enrolled.
Background
Obesity and overweight are significant public health concerns, often leading to conditions like prediabetes and increasing the risk of Type 2 Diabetes. Lifestyle interventions, including physical activity, are crucial for managing these conditions. Understanding the specific mechanisms through which exercise impacts metabolic health, such as its influence on the gut microbiome and serum short chain fatty acids, could inform more targeted and effective treatment strategies for individuals with overweight, obesity, and prediabetes.
Trial design
This completed Phase NA study enrolled 77 participants, originally planned for 100. It investigated individuals 30-64 years old with Overweight or Obesity and PreDiabetes, including those with Type 2 Diabetes. The randomized controlled 2-arm parallel trial examined how 8 weeks of supervised moderate-intensity treadmill walking exercise (30-45 min, 3 times/week) altered the gut microbiome, serum short chain fatty acids, cardiometabolic profile, body weight, and body composition. The intervention group received the exercise regimen, while a control group did not receive the specific exercise intervention.
Key results
The trial reported several key measurements comparing the intervention and control groups:
- Change in Shannon Index (Unitless) (units on a scale): Intervention mean -0.20 (Standard Error .073); Control mean 0.013 (Standard Error .072).
- Change in Serum Short Chain Fatty Acids (SCFA) (score on a scale): Intervention mean 0.19 (Standard Error 0.107); Control mean 0.08 (Standard Error 0.101).
- High-density Lipoprotein Cholesterol (HDL-C) (mg/dL): Intervention mean 53.4 (Standard Error 0.73); Control mean 51.7 (Standard Error 0.69).
- Triglycerides (mg/dL): Intervention mean 147.2 (Standard Error 7.08); Control mean 142.7 (Standard Error 6.70).
- Fasting Insulin (pm/L): Intervention mean 132.5 (Standard Error 8.96); Control mean 134.8 (Standard Error 8.44).
- Fasting Glucose (mg/dL): Intervention mean 105.0 (Standard Error 1.42); Control mean 105.0 (Standard Error 1.35).
What this means
The results suggest an 8-week moderate-intensity treadmill walking exercise intervention can lead to measurable changes in the gut microbiome and certain cardiometabolic markers in adults with overweight or obesity and prediabetes. The intervention group experienced a decrease in the Shannon Index, indicating altered gut microbiome diversity, and a greater increase in serum short chain fatty acids. Additionally, this group showed lower mean fasting insulin and higher mean HDL-C levels compared to controls, with similar fasting glucose. These findings contribute to understanding the physiological effects of structured exercise on metabolic health and gut microbiota in this at-risk population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study titled 'The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults' were posted on 2025-06-13 on clinicaltrials.gov.