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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
15
Each dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose.
Performance First
Virginia Beach, Virginia, United States
Change in Salivary Cortisol - Phase 1
Diurnal salivary samples will be collected and tested for cortisol levels \[ng/ml\].
Time frame: Day 1 and 15
Change in Salivary Cortisol - Phase 2
Diurnal salivary samples will be collected and tested for cortisol levels \[ng/ml\].
Time frame: Day 1 and 15
Change in Sleep Latency, Duration, and Quality - Phase 1
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.
Time frame: Day 1, 8, and 15
Change in Sleep Latency, Duration, and Quality - Phase 2
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.
Time frame: Day 1, 8, and 15
Change in General Mood - Phase 1
Data from the Depression, Anxiety, and Stress Scale-21 (DASS-21) \[Total score 0-63; higher is more distressed\] will be used non-diagnostically to generate comparative scores which will be analyzed against the cortisol findings to assist in the interpretation of the kava-related outcomes.
Time frame: Day 1, 8, and 15
Change in General Mood - Phase 2
Data from the Depression, Anxiety, and Stress Scale-21 (DASS-21) \[Total score 0-63; higher is more distressed\] will be used non-diagnostically to generate comparative scores which will be analyzed against the cortisol findings to assist in the interpretation of the kava-related outcomes.
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Time frame: Day 1, 8, and 15
Change in Motivation and Volition - Phase 1
Data from the Cravings for Rest and Volitional Energy Expenditure Scale (CRAVE) \[Total score 0-50; higher is more motivated\] will be used to assess participant motivation to perform in the context of the strenuous and demanding training schedule of this Prep Class.
Time frame: Day 1, 8, and 15
Change in Motivation and Volition - Phase 2
Data from the Cravings for Rest and Volitional Energy Expenditure Scale (CRAVE) \[Total score 0-50; higher is more motivated\] will be used to assess participant motivation to perform in the context of the strenuous and demanding training schedule of this Prep Class.
Time frame: Day 1, 8, and 15