Influence of Exercise on the Gut Microbiome of Overweight and Obese Adults With Prediabetes

NCT04124354 | Terminated

• 1 other identifier: STUDY00007532
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The investigators propose a 20-participant randomized 2-arm parallel trial with a delayed-intervention control examining how 8 weeks of moderate-intensity walking exercise alters the gut microbiome, short chain fatty acid (SCFA)-producing taxa, and the cardiometabolic profile and body weight of individuals who are overweight or obese and have prediabetes (PreD). Aim 1: Examine and compare exercise-related shifts in the gut microbiome of individuals with PreD. Aim 2: Examine and compare exercise-related changes in SCFA-producing taxa. Exploratory Aim: Examine what percentage of the exercise-related changes observed in participants' gut microbiome and SCFA-producing taxa mediate changes in their cardiometabolic profile and body weight.

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Change in Shannon Index (Alpha-Diversity) as Reflected in Change in Operational Taxonomic Units

  Alpha diversity is the mean species diversity of a local site, which, in this study, is the fecal sample provided by participants used as a proxy for sampling the gut microbiome. The Shannon Index is based on the weighted geometric mean of the proportional abundances of the types of microbes. Change in alpha diversity will be reported as change in operational taxonomic units (OTUs).

  Baseline, 8 weeks

Secondary Outcomes (11)

• Change in Plasma LDL Concentrations

  Baseline, 8 weeks

• Change in Plasma HDL Concentrations

  Baseline, 8 weeks

• Change in Plasma Total Cholesterol Concentrations

  Baseline, 8 weeks

• Change in Plasma Insulin Concentrations

  Baseline, 8 weeks

• Change in Plasma Glucose Concentrations

  Baseline, 8 weeks

Study Arms (2)

Immediate Experimental Group

EXPERIMENTAL

Participants will immediately begin an experimental supervised moderate-intensity treadmill walking intervention program.

Behavioral: Physical Activity

Delayed Intervention Control Group

NO INTERVENTION

Participants will be asked to maintain their usual physical activity during the initial 8-week intervention period but will undergo all data collection procedures. Following the initial intervention period, these participants will be given the option to complete the 8-week intervention, with identical data collection procedures employed.

Interventions

Physical Activity BEHAVIORAL

Participants will attend 3 treadmill walking sessions/week for 8 weeks (24 total)-exercising at 60-75% of their heart rate (HR) reserve monitored using Polar FT1 HR monitors. All walking sessions will take place using treadmills within the West Bank Office Building on the UMN-Twin Cities campus. Each walking session will be 30 min long during intervention weeks 1-4 and 45 min each during weeks 5-8. This exercise dose is equivalent to that employed in the only two human studies of exercise and the gut microbiome in addition to the dosage observed necessary to yield meaningful cardiometabolic changes. After the 4th- and 8th-weeks of the intervention, participants in both study groups will again undergo outcome assessments

Immediate Experimental Group

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Classified as overweight or obese with BMI 25.0-39.9 kg/m2
• Diagnosis of prediabetes as classified by a fasted blood glucose of 100 - 125 mg/dL, 2-hour oral glucose tolerance test of 140 - 199 mg/dL, or HbA1C level of 5.7% - 6.5%
• Currently engaged in \< 150 minutes/week of physical activity-confirmed via the Modifiable Activity Questionnaire

You may not qualify if:

• Individuals with contraindications to exercise participation as assessed by the Physical Activity Readiness Questionnaire
• Self-reported physical/mental disabilities or gastrointestinal conditions
• Antibiotic usage within the last 45 days

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Epidemiology Clinical Research Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 11, 2019
• Study Start: February 10, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)