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Normal-weight ObesityAHA-NWONCT06970457

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

A study testing Resistance Exercise Training and Aerobic Exercise Training in people with Normal-weight Obesity, run by Oklahoma State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years, men onlyHealthy volunteers can take part
Conditions the study is for
Normal-weight Obesity
What is being tested?
Resistance Exercise Training and Aerobic Exercise Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteUnited States
Study dates
15 Apr 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sam Emerson, PhD contact

4057442303

sam.emerson@okstate.edu

Bree Baker, PhD contact

405-744-9315

bree.baker@okstate.edu

United States1 site, 1 recruiting
  • Oklahoma State University

    Stillwater, Oklahoma, 74078

    Sam Emerson, PhD, 405-744-2303, sam.emerson@okstate.edu

    Bree Baker, PhD, 405-744-9315, bree.baker@okstate.edu

    Recruiting

Other trials in United States

About this study

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.

Being tested
Resistance Exercise Training, Aerobic Exercise Training
Keywords
body composition, sex hormones, exercise, metabolic health
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance Exercise TrainingBehavioural

    12-week progressive and individualized resistance exercise training program

  • Aerobic Exercise TrainingBehavioural

    12-week progressive and individualized aerobic exercise training program

Study groups in NCT06970457
Study groupRoleWhat they receive
Resistance Exercise TrainingExperimental12-weeks of progressive and individualized resistance exercise training
Receives: Behavioral: Resistance Exercise Training; Behavioral: Aerobic Exercise Training
Aerobic Exercise TrainingActive comparator12-weeks of progressive and individualized aerobic exercise training
Receives: Behavioral: Resistance Exercise Training; Behavioral: Aerobic Exercise Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fat Mass

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

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Secondary outcomes (15)
  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Baseline/enrollment

  5. Body Mass

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2025
  2. Study start15 Apr 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06970457
Sponsor's protocol ID
IRB-24-542
Acronym
AHA-NWO
Status last verified
Oct 2026
First submitted
14 Mar 2025
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Resistance Exercise Training and Aerobic Exercise Training in people with Normal-weight Obesity, run by Oklahoma State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sam Emerson, PhD (4057442303, sam.emerson@okstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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