Clinical trial NCT05381025: Kavalactones on Sleep and Cortisol in Healthy Special Forces Trainees
Official title: The Effect of Oral Kavalactones on Sleep and Cortisol in a Cohort of Healthy Adult Males Preparing for Military Special Forces Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Sleep
Kava
Piper methysticum
Stress
Cortisol
Special Operations
Lead sponsor: Thorne HealthTech, Inc
Sponsor class: INDUSTRY
Collaborators: name: Performance First
First posted: 2022-05-19
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Salivary Cortisol - Phase 1
timeFrame: Day 1 and 15
measure: Change in Salivary Cortisol - Phase 2
timeFrame: Day 1 and 15
measure: Change in Sleep Latency, Duration, and Quality - Phase 1
timeFrame: Day 1, 8, and 15
measure: Change in Sleep Latency, Duration, and Quality - Phase 2
timeFrame: Day 1, 8, and 15
Secondary outcomes:
measure: Change in General Mood - Phase 1
timeFrame: Day 1, 8, and 15
measure: Change in General Mood - Phase 2
timeFrame: Day 1, 8, and 15
measure: Change in Motivation and Volition - Phase 1
timeFrame: Day 1, 8, and 15
measure: Change in Motivation and Volition - Phase 2
timeFrame: Day 1, 8, and 15
Other outcomes:
Locations:
city: Virginia Beach
country: United States
facility: Performance First
state: Virginia
Study officials:
affiliation: Advanced Pattern Analysis & Countermeasures Group
name: Michael A Schmidt, PhD, MPhil
role: PRINCIPAL_INVESTIGATOR
References: