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Recruiting NCT06970457

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

No phase Interventional Normal-weight Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resistance Exercise Training, Aerobic Exercise Training.
Who it may be relevant to
Registry conditions: Normal-weight Obesity. Basic parameters: 18 years — 79 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral Resistance Exercise Training
    12-week progressive and individualized resistance exercise training program
  • Behavioral Aerobic Exercise Training
    12-week progressive and individualized aerobic exercise training program

Primary outcome measures

  • Fat Mass [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Lean mass [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Testosterone [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Human Growth Hormone [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Estradiol [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • SHBG [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Luteinizing Hormone [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • FSH [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Adiponectin [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Leptin [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
Secondary outcome measures (12)
  • ALT [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • AST [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Bone Mineral Density [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Height [Time frame: Baseline/enrollment]
  • Body Mass [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Waist Circumference [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Free-living Dietary Intake [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Free-living Physical Activity [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Aerobic Capacity [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Resting Energy Expenditure [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Upper-body Muscle Strength [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]
  • Lower-body Muscle Strength [Time frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Oklahoma State University — Stillwater

Identifiers

NCT: NCT06970457 · IRB-24-542

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗