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Completed

NCT Number: NCT05381025

Kavalactones on Sleep and Cortisol in Healthy Special Forces Trainees

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Performance First

Virginia Beach, Virginia, 23453, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kava (Piper methysticum) extract

Dietary Supplement

Each dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose.

Primary outcomes

  1. Change in Salivary Cortisol - Phase 1

    Time frame: Day 1 and 15

    Diurnal salivary samples will be collected and tested for cortisol levels [ng/ml].

  2. Change in Salivary Cortisol - Phase 2

    Time frame: Day 1 and 15

    Diurnal salivary samples will be collected and tested for cortisol levels [ng/ml].

  3. Change in Sleep Latency, Duration, and Quality - Phase 1

    Time frame: Day 1, 8, and 15

    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.

  4. Change in Sleep Latency, Duration, and Quality - Phase 2

    Time frame: Day 1, 8, and 15

    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.

Secondary outcomes

  1. Change in General Mood - Phase 1

    Time frame: Day 1, 8, and 15

    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.

  2. Change in General Mood - Phase 2

    Time frame: Day 1, 8, and 15

    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.

  3. Change in Motivation and Volition - Phase 1

    Time frame: Day 1, 8, and 15

    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.

  4. Change in Motivation and Volition - Phase 2

    Time frame: Day 1, 8, and 15

    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.

Sponsors and collaborators

Lead sponsor

Thorne HealthTech, Inc

Industry

Collaborators

  • Performance First

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 19, 2022
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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