Kavalactones on Sleep and Cortisol in Healthy Special Forces Trainees

Sponsor

Thorne Research Inc. (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05381025

Collaborator

Performance First (Other)

Enrollment

Location

Arms

1.7

Anticipated Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep	Dietary Supplement: Kava (Piper methysticum) extract	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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 (Participant, 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.

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

May 10, 2022

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: Kava (Piper methysticum) extract Each dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose.
Experimental: 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.	Dietary Supplement: Kava (Piper methysticum) extract Each dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose.

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: Kava (Piper methysticum) extract

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

Experimental: 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.

Dietary Supplement: Kava (Piper methysticum) extract

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

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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