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Anaerobic Exercise and Mental Acuity

Primary Purpose

Depression, LPS, Mood

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
weight training
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • 850 PBCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

weight training

no prescribed weight training

Arm Description

A prescribed 8-week training protocol

no prescribed weight training

Outcomes

Primary Outcome Measures

gut barrier integrity
serum LPS binding protein

Secondary Outcome Measures

mood state
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

Full Information

First Posted
April 24, 2023
Last Updated
May 8, 2023
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT05850221
Brief Title
Anaerobic Exercise and Mental Acuity
Official Title
Anaerobic Exercise as a Modulator of Microbial Composition and Mental Acuity in Sedentary Men
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
April 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, LPS, Mood

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial (waitlist control)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
weight training
Arm Type
Experimental
Arm Description
A prescribed 8-week training protocol
Arm Title
no prescribed weight training
Arm Type
No Intervention
Arm Description
no prescribed weight training
Intervention Type
Other
Intervention Name(s)
weight training
Intervention Description
weight training
Primary Outcome Measure Information:
Title
gut barrier integrity
Description
serum LPS binding protein
Time Frame
change from baseline at week 8
Secondary Outcome Measure Information:
Title
mood state
Description
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
Time Frame
change from baseline at week 8
Other Pre-specified Outcome Measures:
Title
anaerobic capacity
Description
wingate test
Time Frame
change from baseline at week 8

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carol S Johnston
Phone
602-496-2539
Email
carol.johnston@asu.edu
Facility Information:
Facility Name
850 PBC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol S Johnston, PhD
Phone
602-965-2539
Email
carol.johnston@asu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Anaerobic Exercise and Mental Acuity

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