Sleep
Conditions
Keywords
Sleep, Kava, Piper methysticum, Stress, Cortisol, Special Operations
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTKava (Piper methysticum) extract
Each dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose.
Sponsors
Performance First
Thorne HealthTech, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Latency, Duration, and Quality - Phase 2 | 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 | Day 1 and 15 | Diurnal salivary samples will be collected and tested for cortisol levels \[ng/ml\]. |
| Change in Salivary Cortisol - Phase 2 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in General Mood - Phase 1 | 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. |
| Change in General Mood - Phase 2 | 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. |
| Change in Motivation and Volition - Phase 1 | 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. |
| Change in Motivation and Volition - Phase 2 | 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. |
Countries
United States
Outcome results
None listed