Kavalactones on Sleep and Cortisol in Healthy Special Forces Trainees

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05381025
• Other study ID #: THT002-PFKV01
• Status: Completed
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: October 9, 2022

Study information

• Verified date: October 2022
• Source: Thorne Research Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 9, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Dietary Supplement:
• Kava (Piper methysticum) extract
Each dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose.

Locations

Country	Name	City	State
United States	Performance First	Virginia Beach	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Thorne Research Inc.	Performance First

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Salivary Cortisol - Phase 1	Diurnal salivary samples will be collected and tested for cortisol levels [ng/ml].	Day 1 and 15
Primary	Change in Salivary Cortisol - Phase 2	Diurnal salivary samples will be collected and tested for cortisol levels [ng/ml].	Day 1 and 15
Primary	Change in Sleep Latency, Duration, and Quality - Phase 1	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.	Day 1, 8, and 15
Primary	Change in Sleep Latency, Duration, and Quality - Phase 2	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.	Day 1, 8, and 15
Secondary	Change in General Mood - Phase 1	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.	Day 1, 8, and 15
Secondary	Change in General Mood - Phase 2	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.	Day 1, 8, and 15
Secondary	Change in Motivation and Volition - Phase 1	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.	Day 1, 8, and 15
Secondary	Change in Motivation and Volition - Phase 2	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.	Day 1, 8, and 15