NCT02296788

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

November 18, 2014

Last Update Submit

January 7, 2016

Conditions

Gut Microbiota

Keywords

Gut Microbiota

Outcome Measures

Primary Outcomes (1)

  • Gut Microbiota

    1 year

Study Arms (3)

No Exercise Control

NO INTERVENTION

Healthy Living Control Group

Aerobic Exercise Group

EXPERIMENTAL

8 kcal/kg of body weight/week (KKW) (\~900 kcal/wk)

Behavioral: Aerobic Exercise

Aerobic Exercise Group 2

EXPERIMENTAL

20 KKW (\~2250 kcal/wk)

Behavioral: Aerobic Exercise

Interventions

Aerobic ExerciseBEHAVIORAL

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.

Aerobic Exercise GroupAerobic Exercise Group 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 20, 2014

Study Start

June 1, 2015

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

January 11, 2016

Record last verified: 2016-01