- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05850221
Anaerobic Exercise and Mental Acuity
May 8, 2023 updated by: Arizona State University
Anaerobic Exercise as a Modulator of Microbial Composition and Mental Acuity in Sedentary Men
This is a randomized controlled trial to examine the effect of anaerobic activity (e.g., weight training) on gut microbiome metabolism and neurological health in healthy sedentary men.
Study Overview
Detailed Description
The human gut microbiome, which houses over 2,000 distinct bacterial species, has recently been characterized as a highly influential force on the health and longevity of its host.
By way of several distinct pathways comprising the "microbiome-gut-brain axis", this diverse population is known to communicate with the human brain in a bidirectional manner and is implicated in the pathophysiology of several metabolic and psychological disease states.
The ability to support a healthy, diverse microbiome through modifiable behavioral interventions - such as diet and exercise - is a topic of growing interest.
Most of the evidence pertaining to the relationship between physical activity and the gut-brain axis at this time, however, investigates the influence of aerobic exercise providing limited insight to how other modalities of physical activity may differ.
Specifically, this study will examine the impact of an 8-week weight training protocol on gut microbiome metabolism and neurological health in healthy sedentary men.
Participants will be randomly assigned to the intervention group or the waitlist control group.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carol S Johnston
- Phone Number: 602-496-2539
- Email: carol.johnston@asu.edu
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Recruiting
- 850 PBC
-
Contact:
- Carol S Johnston, PhD
- Phone Number: 602-965-2539
- Email: carol.johnston@asu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- free of any existing medical diagnoses
- willing and able to participate in moderate to vigorous exercise as determined by the ACSM Health/Fitness Facility Preparticipation Screening Questionnaire
- sedentary (defined as a score <14 on the Godin-Shepard Leisure Time Physical Activity Questionnaire (GSLTQ))
- equipped with access to a complete gym
Exclusion Criteria:
- antibiotic use within the past six months
- prebiotic, probiotic, or high-dose antioxidant supplementation within the past 6 months
- smoker (cigarettes and/or marijuana)
- regular laxative use
- blood pressure >129/80 at baseline
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: weight training
A prescribed 8-week training protocol
|
weight training
|
No Intervention: no prescribed weight training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gut barrier integrity
Time Frame: change from baseline at week 8
|
serum LPS binding protein
|
change from baseline at week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mood state
Time Frame: change from baseline at week 8
|
Depression score on Center for Epidemiological Studies-Depression (CES-D) questionnaire. Scores range from 0-60, with scores >15 indicating an elevated risk of depression and scores >30 indicating elevated symptoms of depression that may influence the health of the individual |
change from baseline at week 8
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
anaerobic capacity
Time Frame: change from baseline at week 8
|
wingate test
|
change from baseline at week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2023
Primary Completion (Anticipated)
October 15, 2023
Study Completion (Anticipated)
April 14, 2024
Study Registration Dates
First Submitted
April 24, 2023
First Submitted That Met QC Criteria
May 8, 2023
First Posted (Actual)
May 9, 2023
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00017316
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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