Gut MicrobiotaEGMNCT02296788
Effects of Aerobic Exercise on Gut Microbiota
A study testing Aerobic Exercise in people with Gut Microbiota, run by Pennington Biomedical Research Center.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota
- What is being tested?
- Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official title: 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.
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.
- Conditions
- Gut Microbiota
- Being tested
- Aerobic Exercise
- Keywords
- Gut Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| No Exercise Control | No intervention | Healthy Living Control Group |
| Aerobic Exercise Group | Experimental | 8 kcal/kg of body weight/week (KKW) (~900 kcal/wk) Receives: Behavioral: Aerobic Exercise |
| Aerobic Exercise Group 2 | Experimental | 20 KKW (~2250 kcal/wk) Receives: Behavioral: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiota
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJun 2015
- Primary completionNov 2015 (estimated)
- Study completionJan 2016 (estimated)
Why it stopped: Study wasn't stopped. It wasn't started. Funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Apolzan, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296788
- Sponsor's protocol ID
- PBRC 2014-062
- Acronym
- EGM
- Status last verified
- Jan 2016
- First submitted
- 18 Nov 2014
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise on Gut Microbiota (EGM) - P & F Ancillary Study (E-Mechanic)
- ClinicalTrials.gov ID
- NCT02296788
- Acronym / sponsor ID
- EGM / PBRC 2014-062
- Conditions
- Gut Microbiota
- Keywords
- Gut Microbiota
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study wasn't stopped. It wasn't started. Funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Exercise Control | No intervention | –Healthy Living Control Group |
| Aerobic Exercise Group | Experimental | Behavioral: Aerobic Exercise8 kcal/kg of body weight/week (KKW) (~900 kcal/wk) |
| Aerobic Exercise Group 2 | Experimental | Behavioral: Aerobic Exercise20 KKW (~2250 kcal/wk) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseThe 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. | Behavioural | Aerobic Exercise Group, Aerobic Exercise Group 2 |
Primary outcome
Gut Microbiota
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Gut Microbiota, run by Pennington Biomedical Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiota (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.