CClinicalTrials.gg
WithdrawnNCT02296788EGMUpdated Jan 11, 2016

Effects of Aerobic Exercise on Gut Microbiota

An interventional study of Aerobic Exercise in Gut Microbiota, sponsored by Pennington Biomedical Research Center. Withdrawn. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-11.

Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Study wasn't stopped. It wasn't started. Funding.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Gut Microbiota

Keywords

  • Gut Microbiota
03

In context

Lead sponsor

Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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

  • Experimental
    Aerobic Exercise Group 2

    20 KKW (\~2250 kcal/wk)

    Behavioral: Aerobic Exercise

Interventions

  • BehavioralAerobic 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.

06

What researchers measure

Primary outcomes

  1. Gut Microbiota

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02296788
Lead sponsor
Pennington Biomedical Research Center
Responsible party
John Apolzan (Assistant Professor, Pennington Biomedical Research Center) — Principal investigator
First posted
Nov 20, 2014
Start date
Jun 2015
Primary completion
Nov 2015 (estimated)
Completion
Jan 2016 (estimated)
Last update
Jan 11, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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