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

NCT ID: NCT04931836

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-29
• Study Completion Date: 2023-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

Participants in this group will complete the physical activity intervention.

Group Type: EXPERIMENTAL

Physical Activity Intervention

Intervention Type: 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.

Control Group

Participants in this group will be asked to maintain their normal level of physical activity.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Demmer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00009136

Identifier Type: -

Identifier Source: org_study_id