Effects of Aerobic Exercise on Gut Microbiota (EGM)

Effects of Aerobic Exercise on Gut Microbiota (EGM) - P & F Ancillary Study (E-Mechanic)

In the present study, we seek to elucidate the effects of aerobic exercise on fecal microbiota following the aforementioned no exercise control group and two doses of aerobic exercise training (the exercise training spans ~24 wks) in a cross-sectional sample.

Study Overview

• Status: Withdrawn
• Conditions: Gut Microbiota
• Intervention / Treatment: Behavioral: Aerobic Exercise

Detailed Description

We will collect ancillary data for the ongoing Examination of Mechanisms of exercise-induced weight compensation (E-Mechanic; RCT; Martin CK and Church TS Co-PI's; R01 HL 102166) to investigate the independent aim and hypothesis of this pilot and feasibility (P & F) grant examining if there are differences in colonic microbial populations from a fecal sample following supervised and controlled aerobic exercise.

The proposed study seeks to better understand the role of colonic microbial populations as a mechanism of change in body weight during aerobic exercise. E-Mechanic is examining the effects of 2 tightly controlled and supervised doses of aerobic exercise, and a no-exercise control group, on energy balance and body weight over 24 wks in overweight and obese persons. The two aerobic exercise doses were: 1) 8 kcal/kg of body weight/week (KKW) (~900 kcal/wk) and 2) 20 KKW (~2250 kcal/wk) compared to a no exercise control group. The low dose of exercise (8 KKW) represents the American College of Sports Medicine (ACSM) recommendation for overall health and the higher dose (20 KKW) the recommendation for weight loss and weight loss maintenance.

Aim 1 To investigate if colonic bacterial populations differ between the exercise groups and the healthy living control group following aerobic exercise.

It is hypothesized that participants in the exercise group will have different bacterial populations than those in the healthy living control group.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Participants are overweight or obese (BMI 25 ≥ kg/m2 and ≤ 45 kg/m2), not actively exercising > 20 min on ≥ 3 days/wk, weight stable, non-diabetic, non-smoker, and not have any major medical disorders including such as HIV, CVD, mental illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Exercise Control; Healthy Living Control Group
Experimental: Aerobic Exercise Group; 8 kcal/kg of body weight/week (KKW) (~900 kcal/wk)	Behavioral: Aerobic Exercise; The exercise expenditure goals were calculated by multiplying the participants' body weight by the exercise dose (8 or 20 KKW) divided by the number of sessions (3-5 sessions/wk). The speed and grade were monitored and documented to keep participant heart rate at 65-85% of tested VO2 peak and entered into ACSM equations for energy expenditure.
Experimental: Aerobic Exercise Group 2; 20 KKW (~2250 kcal/wk)	Behavioral: Aerobic Exercise; The exercise expenditure goals were calculated by multiplying the participants' body weight by the exercise dose (8 or 20 KKW) divided by the number of sessions (3-5 sessions/wk). The speed and grade were monitored and documented to keep participant heart rate at 65-85% of tested VO2 peak and entered into ACSM equations for energy expenditure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gut Microbiota	1 year

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: November 18, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Estimate): January 11, 2016
• Last Update Submitted That Met QC Criteria: January 7, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Gut Microbiota
• Other Study ID Numbers: PBRC 2014-062