Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations
Condition: Caloric Restriction; Exercise; Sleep
Intervention: Testosterone Undecanoate; Sesame Oil
Intervention description: single intramuscular injection of 750 mg testosterone undecanoate; single intramuscular injection of 750 mg sesame oil solution
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: Male
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: testosterone; anabolism; muscle mass; military operational stress

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.
    

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