Kavalactones on Sleep and Cortisol in Healthy Special Forces Trainees

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2022-10-09

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.

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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.

Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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Active to Placebo (Cohort 1)

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.

Group Type EXPERIMENTAL

Kava (Piper methysticum) extract

Intervention Type DIETARY_SUPPLEMENT

Each dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose.

Placebo to Active (Cohort 2)

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.

Group Type EXPERIMENTAL

Kava (Piper methysticum) extract

Intervention Type DIETARY_SUPPLEMENT

Each dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose.

Interventions

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Kava (Piper methysticum) extract

Each dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose.

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes