Clinical trial NCT06970457: The Interaction of Body Composition, Sex Hormones and Exercise in Men
Official title: The Interaction of Body Composition, Sex Hormones and Exercise in Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Normal-weight Obesity
Keywords: body composition
sex hormones
exercise
metabolic health
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2025-05-14
Enrollment: 96
Sex: MALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: Fat Mass
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Lean mass
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Testosterone
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Human Growth Hormone
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Estradiol
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: SHBG
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Luteinizing Hormone
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: FSH
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Adiponectin
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Leptin
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Aromatase
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Insulin
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: KISS1
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: GnRH
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Inflammatory Cytokine Panel
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Triglycerides
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Glucose
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: HDL-C
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Total Cholesterol
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Visceral Adipose Tissue
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
Secondary outcomes:
measure: ALT
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: AST
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Bone Mineral Density
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Height
timeFrame: Baseline/enrollment
measure: Body Mass
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Waist Circumference
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Free-living Dietary Intake
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Free-living Physical Activity
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Aerobic Capacity
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Resting Energy Expenditure
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Upper-body Muscle Strength
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Lower-body Muscle Strength
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Upper-body Muscle Power
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Lower-body Muscle Power
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
measure: Blood Pressure
timeFrame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: Oklahoma State University
state: Oklahoma
Study officials:
affiliation: Oklahoma State University
name: Sam Emerson, PhD
role: PRINCIPAL_INVESTIGATOR
References: