Performance First
Virginia Beach, Virginia, 23453, United States
NCT Number: NCT05381025
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.
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Notify Me18 year and older
Male
Interventional
Not applicable
Virginia Beach, Virginia, 23453, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose.
Time frame: Day 1 and 15
Diurnal salivary samples will be collected and tested for cortisol levels [ng/ml].
Time frame: Day 1 and 15
Diurnal salivary samples will be collected and tested for cortisol levels [ng/ml].
Time frame: 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.
Time frame: 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.
Time frame: Day 1, 8, and 15
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
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
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
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.
Thorne HealthTech, Inc
Industry
The Effect of Oral Kavalactones on Sleep and Cortisol in a Cohort of Healthy Adult Males Preparing for Military Special Forces Training
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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