Phase 4
Completed N=34
Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations
Caloric Restriction · Exercise · Sleep
Source: ClinicalTrials.gov NCT04120363 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcomePrimary: Load Carriage Time — 45.21; 41.58; 50.95; 47.15 min
◆ Published Evidence
Established
26citations · ~9 / year
Monitoring body composition change for intervention studies with advancing 3D optical imaging technology in comparison to dual-energy X-ray absorptiometry.
Summary
The objective of this study is to determine the effects of a single dose of testosterone undecanoate during and in recovery from simulated operational stress.
Linked Publications (4)
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Monitoring body composition change for intervention studies with advancing 3D optical imaging technology in comparison to dual-energy X-ray absorptiometry.
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Effects of testosterone undecanoate on performance during multi-stressor military operations: A trial protocol for the Optimizing Performance for Soldiers II study.
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Bioelectrical impedance phase angle is associated with physical performance before but not after simulated multi-stressor military operations.
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Exercise Heart Rate Variability Suggests Parasympathetic Hyperactivity during Simulated Military Operations Irrespective of Testosterone Administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Load Carriage Time |
45.21; 41.58; 50.95; 47.15; 44.31; 39.34 | — |
| PRIMARY Vertical Jump Height |
54.5; 53.6; 49.1; 50.0; 54.0; 50.5 | — |
| PRIMARY Total Mass Lifted |
127.4; 127.9; 122.7; 119.0; 126.7; 129.8 | — |
| PRIMARY Wingate Peak Power |
879.4; 837.8; 753.8; 736.0; 821.8; 790.8 | — |
| PRIMARY Peak Aerobic Capacity |
3.22; 3.28; 3.13; 3.20; 3.29; 3.44 | — |
| SECONDARY Body Composition |
59.2; 59.8; 59.6; 57.9; 59.5; 59.6 | — |
Eligibility Criteria
Inclusion Criteria
- Men aged 18-35 years
- Ability to understand verbal or written instructions/testing materials in English
- Physically active (as determined by accelerometry and review of a physical activity log)
- Not taking any prescription medications and/or willing to refrain from all medication use prior to and throughout the entire study period, unless provided/approved by the study physician
- Willing to refrain from alcohol, smoking, e-cigarettes or use of any nicotine product, caffeine, and dietary supplement use throughout the entire study period
- Willing to live on the Pennington Biomedical Research Center inpatient unit for 20 consecutive days
- Meets age-specific US Army body composition standards according to Army Regulation 600-9, which includes estimates of percent body fat based on height, weight, and circumference measures (neck and waist)
- Total testosterone concentration is within the normal physiological range (300-1,000 ng/dL)
Exclusion Criteria
- Musculoskeletal injuries that compromise exercise capability
- Diagnosed cardiometabolic disorders (i.e., hypertension, hyperlipidemia, kidney disease, diabetes, etc.)
- Allergies or intolerance to foods, vegetarian practices, or history of complications with lidocaine
- Anabolic steroid, human growth hormone, or nutritional testosterone precursor-like supplement use within the past 6 months
- Will not refrain from smoking (any nicotine product), alcohol, caffeine, or any other dietary supplement during the study
- Adults unable to consent
- Women
- Prisoners
- Sedentary or engages in insufficient quantities of physical activity per week (aerobic and/or resistance training as determined by accelerometry and review of a physical activity log)
- Exceeds age-specific US Army body composition standards according to Army Regulation 600-9
- Previous history of kidney stones unless otherwise approved by the medical investigator
- Systolic blood pressure > 150 or diastolic blood pressure > 95 mmHg
- Previous history of breast or prostate cancer
- Previous history of Chronic Obstructive Pulmonary Disease or Obstructive Sleep Apnea
- Prostate-Specific Antigen (PSA) > 3ng/ml, Hematocrit > 50%, or positive urine drug screening
- Based on the investigative team's clinical judgment, a subject may not be appropriate for participation in the study
Data sourced from ClinicalTrials.gov (NCT04120363) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.