Health TrialsbyHealthPanel

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

ConditionNormal-weight Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-79
SponsorOklahoma State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Resistance Exercise Training

    Behavioral

    12-week progressive and individualized resistance exercise training program

  • Aerobic Exercise Training

    Behavioral

    12-week progressive and individualized aerobic exercise training program

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Resistance Exercise TrainingExperimental treatment 2 interventions
Group B: Aerobic Exercise TrainingActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Fat Mass

Fat mass, measured in kg and as a percentage of total body mass Measured through dual-energy X ray absorptiometry

Time frame
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
2

Lean mass

Lean mass, measured in kg and as a percentage of total body mass Measured through dual-energy X ray absorptiometry

Time frame
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
3

Testosterone

Human testosterone, measured in serum via Novus Biologicals Human Testosterone ELISA Kit (Colorimetric). Measured in pg/mL.

Time frame
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
4

Human Growth Hormone

Human Growth Hormone (HGH), measured in serum via R\&D Systems™ Human Growth Hormone Quantikine ELISA Kit Measured in pg/mL

Time frame
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants

Secondary outcomes

1

ALT

Alanine Transaminase (ALT) liver enzyme, measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in U/L

Time frame
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
2

AST

Aspartate Aminotransferase (AST), measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in U/L

Time frame
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
3

Bone Mineral Density

Whole-body Bone Mineral Density (BMD), measured via dual-energy X ray absorptiometry; measured in g/cm3

Time frame
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
4

Height

Height, measured in inches via portable stadiometer

Time frame
Baseline/enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oklahoma State University

Lead sponsor

American Heart Association

Collaborator

Source ClinicalTrials.gov
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