The Effect of Oral Kavalactones on Sleep and Cortisol in a Cohort of Healthy Adult Males Preparing for Military Special Forces Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Salivary Cortisol - Phase 2
研究概览
简要总结
This research study is being done to better understand the effects of kava supplementation on sleep quality and salivary cortisol in the context of the acute physical and psychological stress of military special forces preparation training. Kava is a botanical dietary supplement derived from the plant Piper methysticum. Cortisol is a hormone associated with stress.
详细描述
Acute physical and behavioral stress can interfere with sleep quality and cause cortisol to increase. This can have a negative impact on quality of life and the ability to perform optimally.
Kava, derived from the rootstumps of the Piper methysticum plant, has been utilized traditionally, socially, and for its calmative properties by the peoples of Oceania for millennia. Kava has been available as a dietary supplement for decades.
Participants in this placebo-controlled cross-over study will be enrolled concurrently with a special operations prep class during which they will be experiencing significant physical and mental stressors. Participants will be divided into two arms - one taking kava and the other taking placebo for the first two-week phase of the study. Following a washout and cross-over, participants will switch what they are taking for the second two-week phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants will be aware of the contents of the active material but will not be informed as to whether they will begin or end the study with the active vs the placebo. Study Managers will also not be aware of what an individual participant is taking during the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Provides consent to participate in the study
- •Understands and agrees to follow all study procedures and limitations
排除标准
- •Use of kava within the past 8 weeks
- •Use of over the counter or prescription sleep aids including dietary supplements within the past 8 weeks
- •Use of acetaminophen that cannot be discontinued or replaced with an NSAID during the study
- •Known liver disease or dysfunction
- •Known kidney disease or dysfunction
- •Any prior adverse reaction or known sensitivity or allergy to kava or related botanicals (peppers)
- •Recent history of clinical depression or anxiety diagnosis
结局指标
主要结局
Change in Salivary Cortisol - Phase 2
时间窗: Day 1 and 15
Diurnal salivary samples will be collected and tested for cortisol levels \[ng/ml\].
Change in Sleep Latency, Duration, and Quality - Phase 2
时间窗: Day 1, 8, and 15
Data from the Restorative Sleep Questionnaire-Weekly (RSQ-W) \[Total score 0-100; higher indicates better restorative sleep\] plus other selected sleep questions will be combined to assess participant sleep during the study.
Change in Salivary Cortisol - Phase 1
时间窗: Day 1 and 15
Diurnal salivary samples will be collected and tested for cortisol levels \[ng/ml\].
Change in Sleep Latency, Duration, and Quality - Phase 1
时间窗: Day 1, 8, and 15
Data from the Restorative Sleep Questionnaire-Weekly (RSQ-W) \[Total score 0-100; higher indicates better restorative sleep\] plus other selected sleep questions will be combined to assess participant sleep during the study.
次要结局
- Change in Motivation and Volition - Phase 1(Day 1, 8, and 15)
- Change in General Mood - Phase 2(Day 1, 8, and 15)
- Change in Motivation and Volition - Phase 2(Day 1, 8, and 15)
- Change in General Mood - Phase 1(Day 1, 8, and 15)