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Anaerobic Exercise and Mental Acuity

Sponsor
Arizona State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05850221
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: weight training
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled trial (waitlist control)randomized controlled trial (waitlist control)
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Anaerobic Exercise as a Modulator of Microbial Composition and Mental Acuity in Sedentary Men
Actual Study Start Date :
Apr 15, 2023
Anticipated Primary Completion Date :
Oct 15, 2023
Anticipated Study Completion Date :
Apr 14, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: weight training

A prescribed 8-week training protocol

Other: weight training
weight training
No Intervention: no prescribed weight training

no prescribed weight training

Outcome Measures

Primary Outcome Measures

  1. gut barrier integrity [change from baseline at week 8]

    serum LPS binding protein

Secondary Outcome Measures

  1. mood state [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

Other Outcome Measures

  1. anaerobic capacity [change from baseline at week 8]

    wingate test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 850 PBC Phoenix Arizona United States 85004

Sponsors and Collaborators

  • Arizona State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Arizona State University
ClinicalTrials.gov Identifier:
NCT05850221
Other Study ID Numbers:
  • STUDY00017316
First Posted:
May 9, 2023
Last Update Posted:
May 9, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Depression

Study Results

No Results Posted as of May 9, 2023