Kavalactones on Sleep and Cortisol in Healthy Special Forces Trainees

NCT05381025 | Completed

• 1 other identifier: THT002-PFKV01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

Sleep; Kava; Piper methysticum; Stress; Cortisol; Special Operations

Outcome Measures

Primary Outcomes (4)

• Change in Salivary Cortisol - Phase 1

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

  Day 1 and 15

• Change in Salivary Cortisol - Phase 2

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

  Day 1 and 15

• 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

• 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 Outcomes (4)

• Change in General Mood - Phase 1

  Day 1, 8, and 15

• Change in General Mood - Phase 2

  Day 1, 8, and 15

• Change in Motivation and Volition - Phase 1

  Day 1, 8, and 15

• Change in Motivation and Volition - Phase 2

  Day 1, 8, and 15

Study Arms (2)

Active to Placebo (Cohort 1)

EXPERIMENTAL

Participants randomly allocated to Cohort 1 for Phase 1 will begin the study taking the active ingredient and will cross-over to taking placebo in Phase 2 of the study after a washout period.

Dietary Supplement: Kava (Piper methysticum) extract

Placebo to Active (Cohort 2)

EXPERIMENTAL

Participants randomly allocated to Cohort 2 for Phase 1 will begin the study taking the placebo and will cross-over to taking the active ingredient in Phase 2 of the study after a washout period.

Dietary Supplement: Kava (Piper methysticum) extract

Interventions

Kava (Piper methysticum) extract DIETARY_SUPPLEMENT

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

Active to Placebo (Cohort 1); Placebo to Active (Cohort 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thorne HealthTech, Inc: lead
• Performance First: collaborator

Study Sites (1)

Performance First

Virginia Beach, Virginia, 23453, United States

Location

Study Officials

• Michael A Schmidt, PhD, MPhil

  Advanced Pattern Analysis & Countermeasures Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be aware of the contents of the active material but will not be informed as to whether they will begin or end the study with the active vs the placebo. Study Managers will also not be aware of what an individual participant is taking during the study.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 19, 2022
• Study Start: May 11, 2022
• Primary Completion: July 1, 2022
• Study Completion: October 9, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)