CClinicalTrials.gg
RecruitingNCT06970457AHA-NWOUpdated May 14, 2025

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

An interventional study of Resistance Exercise Training and Aerobic Exercise Training in Normal-weight Obesity, sponsored by Oklahoma State University. Recruiting at 1 site in United States. Open to male participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by Oklahoma State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Normal-weight Obesity

Keywords

  • body composition
  • sex hormones
  • exercise
  • metabolic health
03

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    Resistance Exercise Training

    12-weeks of progressive and individualized resistance exercise training

    Behavioral: Resistance Exercise Training · Behavioral: Aerobic Exercise Training

  • Active comparator
    Aerobic Exercise Training

    12-weeks of progressive and individualized aerobic exercise training

    Behavioral: Resistance Exercise Training · Behavioral: Aerobic Exercise Training

Interventions

  • BehavioralResistance Exercise Training

    12-week progressive and individualized resistance exercise training program

  • BehavioralAerobic Exercise Training

    12-week progressive and individualized aerobic exercise training program

05

What researchers measure

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

  5. Estradiol

    Human estradiol, measured in serum via Novus Biologicals Human Estradiol 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

  6. SHBG

    Sex Hormone Binding Globulin (SHBG), measured in serum via R\&D Systems™ Human SHBG 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

  7. Luteinizing Hormone

    Luteinizing Hormone (LH), measured in serum via Invitrogen™ Luteinizing Hormone Human 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

  8. FSH

    Follicle Stimulating Hormone (FSH), measured in serum via Invitrogen™ Human FSH 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

  9. Adiponectin

    Adiponectin, measured in serum via Invitrogen™ Adiponectin Human 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

  10. Leptin

    Leptin, measured in serum via Invitrogen™ Leptin Human 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

  11. Aromatase

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

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

  12. Insulin

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

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

  13. KISS1

    Kisspeptin (KISS1), measured in serum via Biomatik Corporation Human Kisspeptin 1 (KISS1) 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

  14. GnRH

    Gonadotropin-releasing hormone (GnRH), measured in serum via Biomatik Corporation Human Gonadotropin Releasing Hormone (GnRH) 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

  15. 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

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

  16. Triglycerides

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

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

  17. Glucose

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

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

  18. 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

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

  19. Total Cholesterol

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

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

  20. Visceral Adipose Tissue

    Visceral Adipose Tissue (VAT), measured in g and g/cm3 via 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

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

  5. Body Mass

    Body mass, measured in kg via Seca mBCA (medical body composition analyzer) 514

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

  6. Waist Circumference

    Waist Circumference, measured in inches via standard Gulick tape measure.

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

  7. Free-living Dietary Intake

    Free-Living Dietary Intake, measured via 3-day food record. Participant completes the record for 3 days and returns to the researchers.

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

  8. Free-living Physical Activity

    Free-living Physical Activity, assessed through accelerometry via Actigraph wGT3X-BT accelerometers. Participant wears the accelerometer for 3 days, then returns it to the researchers.

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

  9. Aerobic Capacity

    Aerobic Capacity, also known as VO2peak, assessed via YMCA submaximal exercise test, completed on a cycle ergometer.

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

  10. Resting Energy Expenditure

    Resting Energy Expenditure (REE), measured via indirect calorimetry. The test is conducted with a Parvo Medics True One 2400 metabolic analysis system with a canopy hood; measured as kcal/day.

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

  11. Upper-body Muscle Strength

    Upper-body Muscle Strength, measured via three-repetition maximum (3RM) bench press; measured in pounds.

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

  12. Lower-body Muscle Strength

    Lower-body Muscle Strength, measured via knee extensor test with a Biodex dynamometer and three-repetition maximum (3RM) leg press exercise; measured as peak torque in Nm and pounds, respectively.

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

  13. Upper-body Muscle Power

    Upper-body Muscle Power, measured via seated medicine ball toss; measured in inches (thrown).

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

  14. Lower-body Muscle Power

    Lower-body Muscle Power, measured via maximal voluntary contraction of the knee extensors with a Biodex dynamometer; measured as peak torque in Nm.

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

  15. Blood Pressure

    Blood Pressure, both systolic and diastolic, measured with an automated blood pressure cuff; measured in mmHg.

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

06

Study locations

1 of 1 sites recruiting
  • Oklahoma State University
    Stillwater, Oklahoma 74078, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06970457
Lead sponsor
Oklahoma State University
Collaborators
American Heart Association
Responsible party
Sponsor
First posted
May 14, 2025
Start date
Apr 15, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 14, 2025

Study contacts

Sam Emerson, PhD
Contact
sam.emerson@okstate.edu
4057442303
Bree Baker, PhD
Contact
bree.baker@okstate.edu
405-744-9315
Sam Emerson, PhD
principal investigator · Oklahoma State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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