Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Performance First | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active to Placebo (Cohort 1) | Experimental | 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. |
|
| Placebo to Active (Cohort 2) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kava (Piper methysticum) extract | Dietary Supplement | Each dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael A Schmidt, PhD, MPhil | Advanced Pattern Analysis & Countermeasures Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Performance First | Virginia Beach | Virginia | 23453 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
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.
| 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 |