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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT04931836
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Physical Activity Intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jul 29, 2021
Status verified
Jun 2025
Primary completion
Nov 30, 2023
Completion
Nov 30, 2023

Study Design

Enrollment
77 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Experimental Group
    Participants in this group will complete the physical activity intervention.
  • No Intervention: Control Group
    Participants in this group will be asked to maintain their normal level of physical activity.

Primary Outcome Measure

Change in Shannon Index (Unitless) [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455-

Find similar trials in Minneapolis, MN

By condition
Obesity / overweightType 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Minnesota· Minneapolis, MN

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