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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
34
single intramuscular injection of 750 mg testosterone undecanoate
single intramuscular injection of 750 mg sesame oil solution
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Load Carriage Time
A load carriage time trial (a militarily relevant aerobic performance assessment) was conducted near the end of each study phase to assess aerobic performance.
Time frame: Day 5 (Phase 1), Day 26 (Phase 2), Day 47 (Phase 3)
Vertical Jump Height
Lower-body peak power was assessed near the end of each phase using a vertical jump test.
Time frame: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
Total Mass Lifted
A 3-repetition maximum deadlift assessed muscular strength, endurance, and explosive power near the end of each study phase.
Time frame: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
Wingate Peak Power
Anaerobic capacity was assessed using a Wingate anaerobic cycle test near the end of each study phase.
Time frame: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
Peak Aerobic Capacity
Peak aerobic capacity was measured via treadmill VO2peak near the end of each study phase.
Time frame: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
Body Composition
A four-compartment (4C) model factoring in body mass, body volume, total body water, and bone mineral content was used to calculate fat-free body mass and fat mass at the end of each study phase.
Time frame: Day 7 (Phase 1), Day 28 (Phase 2), Day 49 (Phase 3)
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