NCT04931836

The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 30 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All eligible and consented participants will complete a 3-week run-in phase during which baseline outcome assessments will be performed. During run-in weeks 1 and 2, participants will wear a Fitbit Inspire 2 smartwatch and complete three unannounced dietary recalls. During the run-in week 3 (see table below), participants will consume their 3-day standardized meal plan on days three through five, obtain a fecal sample, complete a study questionnaire, and complete a study assessment visit. To quantify compliance with the 3-day meal plan, participants will be provided with a paper checklist of all foods to be consumed, and will be asked to indicate which foods were consumed and to document any deviation. The study assessment visit will include a fasting blood draw (at baseline and week eight only), blood pressure in triplicate, weight measure and body fat assessment in duplicate, and a saliva sample.

Conditions

• Obesity
• Overweight
• Overweight and Obesity
• PreDiabetes
• Type 2 Diabetes
• Type 2 Diabetes Mellitus
• Type 2 Diabetes Mellitus in Obese

Interventions

Type	Name	Description
BEHAVIORAL	Physical Activity Intervention	Three walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions will either take place on new commercial treadmills in the Epidemiology Clinical Research Center or remotely at or around a participant's home. Regardless of the walking location, walking sessions will be 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8.

Timeline

• Start date: 2021-07-29
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2021-06-18
• Last updated: 2025-06-13
• Results posted: 2025-06-13

Locations

1 site across 1 country: United States