Recruiting
NA
INTERVENTIONAL
NCT06970457
The Interaction of Body Composition, Sex Hormones and Exercise in Men
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
Resistance Exercise Training
Type:
BEHAVIORAL
Description:
12-week progressive and individualized resistance exercise training program
Name:
Aerobic Exercise Training
Type:
BEHAVIORAL
Description:
12-week progressive and individualized aerobic exercise training program
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
Description:
Fat mass, measured in kg and as a percentage of total body mass Measured through dual-energy X ray absorptiometry
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
Description:
Lean mass, measured in kg and as a percentage of total body mass Measured through dual-energy X ray absorptiometry
Measure:
Testosterone
TimeFrame:
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
Description:
Human testosterone, measured in serum via Novus Biologicals Human Testosterone ELISA Kit (Colorimetric). Measured in pg/mL.
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
Description:
Human Growth Hormone (HGH), measured in serum via R\&D Systems™ Human Growth Hormone Quantikine ELISA Kit Measured in pg/mL
Measure:
Estradiol
TimeFrame:
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
Description:
Human estradiol, measured in serum via Novus Biologicals Human Estradiol ELISA Kit (Colorimetric); measured in pg/mL
Measure:
SHBG
TimeFrame:
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
Description:
Sex Hormone Binding Globulin (SHBG), measured in serum via R\&D Systems™ Human SHBG Quantikine ELISA Kit; measured in pg/mL
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
Description:
Luteinizing Hormone (LH), measured in serum via Invitrogen™ Luteinizing Hormone Human ELISA Kit; measured in pg/mL
Measure:
FSH
TimeFrame:
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
Description:
Follicle Stimulating Hormone (FSH), measured in serum via Invitrogen™ Human FSH ELISA Kit; measured in pg/mL
Measure:
Adiponectin
TimeFrame:
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
Description:
Adiponectin, measured in serum via Invitrogen™ Adiponectin Human ELISA Kit; measured in pg/mL
Measure:
Leptin
TimeFrame:
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
Description:
Leptin, measured in serum via Invitrogen™ Leptin Human ELISA Kit; measured in pg/mL
Measure:
Aromatase
TimeFrame:
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
Description:
Aromatase enzyme, measured in serum via Invitrogen™ Human Aromatase ELISA Kit; measured in ng/mL
Measure:
Insulin
TimeFrame:
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
Description:
Insulin, measured in serum via Eagle Biosciences Inc Insulin Ultrasensitive ELISA; measured in mU/L
Measure:
KISS1
TimeFrame:
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
Description:
Kisspeptin (KISS1), measured in serum via Biomatik Corporation Human Kisspeptin 1 (KISS1) ELISA Kit; measured in pg/mL
Measure:
GnRH
TimeFrame:
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
Description:
Gonadotropin-releasing hormone (GnRH), measured in serum via Biomatik Corporation Human Gonadotropin Releasing Hormone (GnRH) ELISA Kit; measured in pg/mL
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
Description:
Human High Sensitivity T-Cell 15-Plex Discovery Assay®, conducted by Eve Technologies, that includes GM-CSF, IFN-γ, IL-1β, IL-1RA, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p40, IL-12p70, IL-13, MCP-1 and TNFα; measured in pg/mL
Measure:
Triglycerides
TimeFrame:
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
Description:
Triglycerides, measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in mg/dL
Measure:
Glucose
TimeFrame:
Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants
Description:
Glucose, measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in mg/dL
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
Description:
High-density Lipoprotein Cholesterol (HDL-C), measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in mg/dL
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
Description:
Total Cholesterol, measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in mg/dL
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
Description:
Visceral Adipose Tissue (VAT), measured in g and g/cm3 via dual-energy X ray absorptiometry
Trial Information
NCT ID
NCT06970457
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Oklahoma State University
Last Updated
December 15, 2025