Clinical trial NCT04120363: Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations
Official title: A Randomized, Double-blind, Placebo Controlled Trial of Testosterone Undecanoate for Optimizing Physical and Cognitive Performance During Military Operations (OPS II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Caloric Restriction
Exercise
Sleep
Keywords: testosterone
anabolism
muscle mass
military operational stress
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: United States Army Research Institute of Environmental Medicine
name: United States Department of Defense
name: University of Arkansas
First posted: 2019-10-09
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This is a double-blind, randomized, placebo controlled trial in 32 physically active men exposed to 20 complete days (days 8-27) of simulated operational stress followed by 20 complete days of recovery (days 29-48). After completing baseline testing (Phase 1), participants will be randomized to receive either a single intramuscular injection of testosterone undecanoate or an isovolumetric placebo (Day 8). The 20-day simulated operational stress (Phase 2) will be highly controlled (live-in study) and consist of 4 successive cycles of undulating stress, starting with 2 consecutive days of low stress followed by 3 consecutive days of high stress. Low- and high-stress days will result from low and high militarily-relevant exercise-induced energy expenditures, adequate and restricted sleep (8 hours vs. 4 hours daily), and diet restriction to produce energy deficits. After completing Phase 2, participants will be released to resume their habitual physical activity routines and will be provided a controlled diet to consume (Phase 3), to assess recovery from sustained, severe 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

Primary outcomes:
measure: Load Carriage Time
timeFrame: Day 5 (Phase 1), Day 26 (Phase 2), Day 47 (Phase 3)
measure: Vertical Jump Height
timeFrame: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
measure: Total Mass Lifted
timeFrame: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
measure: Wingate Peak Power
timeFrame: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
measure: Peak Aerobic Capacity
timeFrame: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
Secondary outcomes:
measure: Body Composition
timeFrame: Day 7 (Phase 1), Day 28 (Phase 2), Day 49 (Phase 3)
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Jennifer C Rood, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varanoske AN, Harris MN, Hebert C, Howard EE, Johannsen NM, Heymsfield SB, Greenway FL, Margolis LM, Lieberman HR, Church DD, Ferrando AA, Rood JC, Pasiakos SM. Effects of testosterone undecanoate on performance during multi-stressor military operations: A trial protocol for the Optimizing Performance for Soldiers II study. Contemp Clin Trials Commun. 2021 Jul 3;23:100819. doi: 10.1016/j.conctc.2021.100819. eCollection 2021 Sep.