Status:

COMPLETED

Kavalactones on Sleep and Cortisol in Healthy Special Forces Trainees

Lead Sponsor:

Thorne HealthTech, Inc

Collaborating Sponsors:

Performance First

Conditions:

Sleep

Eligibility:

MALE

18+ years

Phase:

NA

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 milit...

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, de...

Eligibility Criteria

Inclusion

  • Age 18 or older
  • Provides consent to participate in the study
  • Understands and agrees to follow all study procedures and limitations

Exclusion

  • 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

Key Trial Info

Start Date :

May 11 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 9 2022

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT05381025

Start Date

May 11 2022

End Date

October 9 2022

Last Update

October 13 2022

Active Locations (1)

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1

Performance First

Virginia Beach, Virginia, United States, 23453