NCT05381025

Kavalactones on Sleep and Cortisol in Healthy Special Forces Trainees

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Thorne HealthTech, Inc · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Kava (Piper methysticum) extract	Each dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose.

Timeline

• Start date: 2022-05-11
• Primary completion: 2022-07-01
• Completion: 2022-10-09
• First posted: 2022-05-19
• Last updated: 2022-10-13

Locations

1 site across 1 country: United States