Kavalactones on Sleep and Cortisol in Healthy Special Forces Trainees

Thorne HealthTech

Status: Completed

Conditions: Sleep

Treatments: Dietary Supplement: Kava (Piper methysticum) extract

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05381025

THT002-PFKV01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Active to Placebo (Cohort 1)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Kava (Piper methysticum) extract

Placebo to Active (Cohort 2)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Kava (Piper methysticum) extract