Recruiting

Normal Weight Obesity

Sponsor:

Oklahoma State University

Code:

NCT06970457

Conditions

Normal-weight Obesity

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Resistance Exercise Training

Aerobic Exercise Training

Study Details

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

Study ID

NCT06970457

Start date

Apr 15, 2025

Status verified date

Oct, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Resistance Exercise Training

12-weeks of progressive and individualized resistance exercise training

active comparator: Aerobic Exercise Training

12-weeks of progressive and individualized aerobic exercise training

Interventions

Resistance Exercise Training

12-week progressive and individualized resistance exercise training program

Aerobic Exercise Training

12-week progressive and individualized aerobic exercise training program

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 ]
  • 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 ]
  • 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 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 ]
  • Estradiol [ Time Frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants ]
  • SHBG [ 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 [ Time Frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants ]
  • FSH [ Time Frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants ]
  • Adiponectin [ Time Frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants ]
  • Leptin [ Time Frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants ]
  • Aromatase [ Time Frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants ]
  • Insulin [ Time Frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants ]
  • KISS1 [ Time Frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants ]
  • GnRH [ Time Frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants ]
  • 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 ]
  • Triglycerides [ Time Frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants ]
  • Glucose [ Time Frame: Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Sam Emerson, PhD

4057442303sam.emerson@okstate.edu

Bree Baker, PhD

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

Locations

Oklahoma State University

Recruiting

Stillwater, Oklahoma, United States, 74078

Contacts

Sam Emerson, PhD

405-744-2303sam.emerson@okstate.edu

Bree Baker, PhD

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

Principal Investigator:

Sam Emerson, Ph.D.

More Information

Sponsor

Oklahoma State University

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

  • body composition
  • sex hormones
  • exercise
  • metabolic health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by Oklahoma State University on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.