Kavalactones on Sleep and Cortisol in Healthy Special Forces Trainees

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Oral Kavalactones on Sleep and Cortisol in a Cohort of Healthy Adult Males Preparing for Military Special Forces Training

Conditions
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Sleep

Intervention / Treatment
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* Dietary Supplement: Kava (Piper methysticum) extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Provides consent to participate in the study Understands and agrees to follow all study procedures and limitations Exclusion Criteria: Female 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will be divided into two arms which will cross-over during a washout period such that each participant will take the active and the placebo in one phase of the two-phase study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active to Placebo (Cohort 1)<br>Participants randomly allocated to Cohort 1 for Phase 1 will begin the study taking the active ingredient and will cross-over to taking placebo in Phase 2 of the study after a washout period. | Dietary Supplement: Kava (Piper methysticum) extract<br>* Each dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose.<br>|
| Experimental: Placebo to Active (Cohort 2)<br>Participants randomly allocated to Cohort 2 for Phase 1 will begin the study taking the placebo and will cross-over to taking the active ingredient in Phase 2 of the study after a washout period. | Dietary Supplement: Kava (Piper methysticum) extract<br>* Each dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Salivary Cortisol - Phase 1 | Diurnal salivary samples will be collected and tested for cortisol levels [ng/ml]. | Day 1 and 15 | 
| Change in Salivary Cortisol - Phase 2 | Diurnal salivary samples will be collected and tested for cortisol levels [ng/ml]. | 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. | 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. | Day 1, 8, and 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Day 1, 8, and 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Kava, Piper methysticum, Stress, Cortisol, Special Operations