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

NCT06970457 | Recruiting

• 1 other identifier: IRB-24-542
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal-weight Obesity

Keywords

body composition; sex hormones; exercise; metabolic health

Outcome Measures

Primary Outcomes (20)

• Fat Mass

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

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

• Lean mass

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

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

• Testosterone

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

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

• Human Growth Hormone

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

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

• Estradiol

  Human estradiol, measured in serum via Novus Biologicals Human Estradiol ELISA Kit (Colorimetric); measured in pg/mL

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

• SHBG

  Sex Hormone Binding Globulin (SHBG), measured in serum via R\&D Systems™ Human SHBG Quantikine ELISA Kit; measured in pg/mL

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

• Luteinizing Hormone

  Luteinizing Hormone (LH), measured in serum via Invitrogen™ Luteinizing Hormone Human ELISA Kit; measured in pg/mL

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

• FSH

  Follicle Stimulating Hormone (FSH), measured in serum via Invitrogen™ Human FSH ELISA Kit; measured in pg/mL

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

• Adiponectin

  Adiponectin, measured in serum via Invitrogen™ Adiponectin Human ELISA Kit; measured in pg/mL

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

• Leptin

  Leptin, measured in serum via Invitrogen™ Leptin Human ELISA Kit; measured in pg/mL

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

• Aromatase

  Aromatase enzyme, measured in serum via Invitrogen™ Human Aromatase ELISA Kit; measured in ng/mL

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

• Insulin

  Insulin, measured in serum via Eagle Biosciences Inc Insulin Ultrasensitive ELISA; measured in mU/L

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

• KISS1

  Kisspeptin (KISS1), measured in serum via Biomatik Corporation Human Kisspeptin 1 (KISS1) ELISA Kit; measured in pg/mL

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

• GnRH

  Gonadotropin-releasing hormone (GnRH), measured in serum via Biomatik Corporation Human Gonadotropin Releasing Hormone (GnRH) ELISA Kit; measured in pg/mL

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

• Inflammatory Cytokine Panel

  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

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

• Triglycerides

  Triglycerides, measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in mg/dL

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

• Glucose

  Glucose, measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in mg/dL

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

• HDL-C

  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

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

• Total Cholesterol

  Total Cholesterol, measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in mg/dL

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

• Visceral Adipose Tissue

  Visceral Adipose Tissue (VAT), measured in g and g/cm3 via dual-energy X ray absorptiometry

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

Secondary Outcomes (15)

• ALT

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

• AST

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

• Bone Mineral Density

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

• Height

  Baseline/enrollment

• Body Mass

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

Study Arms (2)

Resistance Exercise Training

EXPERIMENTAL

12-weeks of progressive and individualized resistance exercise training

Behavioral: Resistance Exercise Training; Behavioral: Aerobic Exercise Training

Aerobic Exercise Training

ACTIVE COMPARATOR

12-weeks of progressive and individualized aerobic exercise training

Behavioral: Resistance Exercise Training; Behavioral: Aerobic Exercise Training

Interventions

Resistance Exercise Training BEHAVIORAL

12-week progressive and individualized resistance exercise training program

Aerobic Exercise Training; Resistance Exercise Training

Aerobic Exercise Training BEHAVIORAL

12-week progressive and individualized aerobic exercise training program

Aerobic Exercise Training; Resistance Exercise Training

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oklahoma State University: lead
• American Heart Association: collaborator

Study Sites (1)

Oklahoma State University

Stillwater, Oklahoma, 74078, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sam Emerson, PhD

  Oklahoma State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sam Emerson, PhD

CONTACT

4057442303; sam.emerson@okstate.edu

Bree Baker, PhD

CONTACT

405-744-9315; bree.baker@okstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: May 14, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

US (1)