■以前,年轻男性在28天的能量不足(EDef)期间每周服用200毫克的庚酸睾酮,与对照组相比,瘦体重和总质量损失较少(优化士兵性能I研究,OPSI).尽管有这样的好处,两组的物理性能均相似。然而,一些实验限制可能妨碍了对性能优势的检测,由于采用的绩效指标缺乏军事相关性,并且所使用的EDef并没有引起士兵进行行动时通常承受的压力。此外,睾酮需要每周注射,引发超生理浓度,并在停止时显著抑制内源性睾酮。因此,这项后续研究将解决这些限制,并检查睾丸激素在剧烈手术中保持焊料性能的功效。
■在OPSII中,32名男性将参加随机调查,安慰剂对照,双盲审判.基线测试后,参与者将被给予睾酮十一酸(750毫克)或安慰剂之前完成四个连续,5天周期模拟多压力源,持续军事行动(SUSOPS)。SUSOPS将包括两个低压力天(1000千卡/天运动诱导的EDEF;8小时/晚上睡眠),其次是三个高压力天(3000千卡/天和4小时/晚)。SUSOPS之后将有23天的恢复期。军事相关的身体表现是主要结果。次要结果包括4-比较身体组成,肌肉和全身蛋白质周转,肌内机制,生物化学,和认知功能/情绪。
■OPSII将确定十一烷酸睾酮是否安全地提高性能,同时减轻肌肉和总质量损失,不损害认知功能,在SUSOPS恢复期间和恢复期间。
■ClinicalTrials.gov标识符:NCT04120363。
UNASSIGNED: Previously, young males administered 200 mg/week of testosterone enanthate during 28 days of energy deficit (EDef) gained lean mass and lost less total mass than controls (Optimizing Performance for Soldiers I study, OPS I). Despite that benefit, physical performance deteriorated similarly in both groups. However, some experimental limitations may have precluded detection of performance benefits, as performance measures employed lacked military relevance, and the EDef employed did not elicit the magnitude of stress typically experienced by Soldiers conducting operations. Additionally, the testosterone administered required weekly injections, elicited supra-physiological concentrations, and marked suppression of endogenous testosterone upon cessation. Therefore, this follow-on study will address those limitations and examine testosterone\'s efficacy for preserving Solder performance during strenuous operations.
UNASSIGNED: In OPS II, 32 males will participate in a randomized, placebo-controlled, double-blind trial. After baseline testing, participants will be administered either testosterone undecanoate (750 mg) or placebo before completing four consecutive, 5-day cycles simulating a multi-stressor, sustained military operation (SUSOPS). SUSOPS will consist of two low-stress days (1000 kcal/day exercise-induced EDef; 8 h/night sleep), followed by three high-stress days (3000 kcal/day and 4 h/night). A 23-day recovery period will follow SUSOPS. Military relevant physical performance is the primary outcome. Secondary outcomes include 4-comparment body composition, muscle and whole-body protein turnover, intramuscular mechanisms, biochemistries, and cognitive function/mood.
UNASSIGNED: OPS II will determine if testosterone undecanoate safely enhances performance, while attenuating muscle and total mass loss, without impairing cognitive function, during and in recovery from SUSOPS.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04120363.