NCT05850221

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

April 24, 2023

Last Update Submit

May 30, 2024

Conditions

DepressionLPSMood

Outcome Measures

Primary Outcomes (1)

  • gut barrier integrity

    serum LPS binding protein

    change from baseline at week 8

Secondary Outcomes (1)

  • mood state

    change from baseline at week 8

Other Outcomes (1)

  • anaerobic capacity

    change from baseline at week 8

Study Arms (2)

weight training

EXPERIMENTAL

A prescribed 8-week training protocol

Other: weight training

no prescribed weight training

NO INTERVENTION

no prescribed weight training

Interventions

weight trainingOTHER

weight training

weight training

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

850 PBC

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled trial (waitlist control)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 9, 2023

Study Start

April 15, 2023

Primary Completion

October 15, 2023

Study Completion

November 15, 2023

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)