The Interaction of Body Composition, Sex Hormones and Exercise in Men

NCT ID: NCT06970457

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-15

Study Completion Date

2026-12-31

Brief Summary

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The overall objective of this project is to advance understanding of the causes of normal weight obesity (NWO) in men, namely the hormone profile and related potential mediating mechanisms, and the efficacy of different modes of exercise to restore body composition and cardiometabolic health in this population.

Detailed Description

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Conditions

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Normal-weight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Resistance Exercise Training

12-weeks of progressive and individualized resistance exercise training

Group Type EXPERIMENTAL

Resistance Exercise Training

Intervention Type BEHAVIORAL

12-week progressive and individualized resistance exercise training program

Aerobic Exercise Training

Intervention Type BEHAVIORAL

12-week progressive and individualized aerobic exercise training program

Aerobic Exercise Training

12-weeks of progressive and individualized aerobic exercise training

Group Type ACTIVE_COMPARATOR

Resistance Exercise Training

Intervention Type BEHAVIORAL

12-week progressive and individualized resistance exercise training program

Aerobic Exercise Training

Intervention Type BEHAVIORAL

12-week progressive and individualized aerobic exercise training program

Interventions

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Resistance Exercise Training

12-week progressive and individualized resistance exercise training program

Intervention Type BEHAVIORAL

Aerobic Exercise Training

12-week progressive and individualized aerobic exercise training program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Biological male
* BMI 18.5 - 24.9 kg/m2 or \>/= 30 kg/m2
* Body fat \<20% or \>/= 25%
* Ability and willingness to engage in an exercise training regimen

Exclusion Criteria

* Presence of a chronic health condition, or regular use of associate prescribed medications, that would substantially impact study variables
* Excessive alcohol use or use of tobacco products, vape products, or illicit drugs
* Presence of an electrical implant, such as a pacemaker
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Oklahoma State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sam Emerson, PhD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University

Locations

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Oklahoma State University

Stillwater, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sam Emerson, PhD

Role: CONTACT

4057442303

Bree Baker, PhD

Role: CONTACT

405-744-9315

Facility Contacts

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Sam Emerson, PhD

Role: primary

405-744-2303

Bree Baker, PhD

Role: backup

405-744-9315

Other Identifiers

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IRB-24-542

Identifier Type: -

Identifier Source: org_study_id

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