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NCT Number: NCT06970457

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

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.

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Key information

Conditions

Normal-weight Obesity Behavior Motor Activity

Age range

18 year–79 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Fat Mass

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

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

  2. Lean mass

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

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

  3. Testosterone

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

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

  4. Human Growth Hormone

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

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

  5. Estradiol

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

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

  6. SHBG

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

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

  7. Luteinizing Hormone

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

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

  8. FSH

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

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

  9. Adiponectin

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

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

  10. Leptin

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

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

  11. Aromatase

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

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

  12. Insulin

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

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

  13. KISS1

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

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

  14. GnRH

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

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

  15. Inflammatory Cytokine Panel

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

    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

  16. Triglycerides

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

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

  17. Glucose

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

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

  18. HDL-C

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

    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

  19. Total Cholesterol

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

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

  20. Visceral Adipose Tissue

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

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

Secondary outcomes

  1. ALT

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

    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

  2. AST

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

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

  3. Bone Mineral Density

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

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

  4. Height

    Time frame: Baseline/enrollment

    Height, measured in inches via portable stadiometer

  5. Body Mass

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

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

  6. Waist Circumference

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

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

  7. Free-living Dietary Intake

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

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

  8. Free-living Physical Activity

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

    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.

  9. Aerobic Capacity

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

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

  10. Resting Energy Expenditure

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

    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.

  11. Upper-body Muscle Strength

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

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

  12. Lower-body Muscle Strength

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

    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.

  13. Upper-body Muscle Power

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

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

  14. Lower-body Muscle Power

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

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

  15. Blood Pressure

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Bree Baker, PhD

CONTACT

[email protected]

405-744-9315

Sam Emerson, PhD

CONTACT

[email protected]

4057442303

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Collaborators

  • American Heart Association

Registry information

Acronym: AHA-NWO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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