Kavalactones on Sleep and Cortisol in Healthy Special Forces Trainees

Not Applicable

Completed

• Conditions: Sleep
• Interventions: Dietary Supplement: Kava (Piper methysticum) extract

• Registration Number: NCT05381025
• Lead Sponsor: Thorne HealthTech, Inc

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.

Study Timeline

• Study First Submitted: 2022-05-09
• Study Start: 2022-05-11
• Study First Submitted QC: 2022-05-14
• Study First Posted: 2022-05-19
• Primary Completion: 2022-07-01
• Status Verified: 2022-10
• Study Completion: 2022-10-09
• Last Update Submitted: 2022-10-11
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active to Placebo (Cohort 1)	Kava (Piper methysticum) extract	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)	Kava (Piper methysticum) extract	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.

Primary Outcome Measures

Name	Time	Method
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 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 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 Outcome Measures

Name	Time	Method
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 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 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.
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.

Trial Locations

Locations (1)

Performance First; 🇺🇸 Virginia Beach, Virginia, United States