A Randomized, Double-blind, Placebo Controlled Trial of Testosterone Undecanoate for Optimizing Physical and Cognitive Performance During Military Operations (OPS II)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Load Carriage Time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
- •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
研究组 & 干预措施
Placebo
single intramuscular injection of 750 mg sesame oil solution on Day 8
干预措施: Sesame Oil (Drug)
Testosterone
single intramuscular injection of 750 mg testosterone undecanoate on Day 8
干预措施: Testosterone Undecanoate (Drug)
结局指标
主要结局
Load Carriage Time
时间窗: Day 5 (Phase 1), Day 26 (Phase 2), Day 47 (Phase 3)
A load carriage time trial (a militarily relevant aerobic performance assessment) was conducted near the end of each study phase to assess aerobic performance.
Vertical Jump Height
时间窗: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
Lower-body peak power was assessed near the end of each phase using a vertical jump test.
Total Mass Lifted
时间窗: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
A 3-repetition maximum deadlift assessed muscular strength, endurance, and explosive power near the end of each study phase.
Wingate Peak Power
时间窗: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
Anaerobic capacity was assessed using a Wingate anaerobic cycle test near the end of each study phase.
Peak Aerobic Capacity
时间窗: Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
Peak aerobic capacity was measured via treadmill VO2peak near the end of each study phase.
次要结局
- Body Composition(Day 7 (Phase 1), Day 28 (Phase 2), Day 49 (Phase 3))
研究者
Jennifer C. Rood
Principal Investigator
Pennington Biomedical Research Center