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

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Locations

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.

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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