SleepNCT05381025
Kavalactones on Sleep and Cortisol in Healthy Special Forces Trainees
A study testing Kava (Piper methysticum) extract in people with Sleep, run by Thorne HealthTech, Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Kava (Piper methysticum) extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 9 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Provides consent to participate in the study
- Understands and agrees to follow all study procedures and limitations
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Kavalactones on Sleep and Cortisol in a Cohort of Healthy Adult Males Preparing for Military Special Forces Training
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.
Read the 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.
- Conditions
- Sleep
- Being tested
- Kava (Piper methysticum) extract
- Keywords
- Sleep, Kava, Piper methysticum, Stress, Cortisol, Special Operations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kava (Piper methysticum) extractDietary supplement
Each dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Kava (Piper methysticum) extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary Cortisol - Phase 1
Diurnal salivary samples will be collected and tested for cortisol levels [ng/ml].
Measured: Day 1 and 15
Change in Salivary Cortisol - Phase 2
Diurnal salivary samples will be collected and tested for cortisol levels [ng/ml].
Measured: 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.
Measured: 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.
Measured: Day 1, 8, and 15
Secondary outcomes (4)
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.
Measured: Day 1, 8, and 15
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.
Measured: Day 1, 8, and 15
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.
Measured: Day 1, 8, and 15
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.
Measured: Day 1, 8, and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start11 May 2022
- Primary completion1 Jul 2022
- Study completion9 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thorne HealthTech, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Performance First
- Responsible party
- Sponsor
- Investigators
- Michael A Schmidt, PhD, MPhil, Principal investigator, Advanced Pattern Analysis & Countermeasures Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381025
- Sponsor's protocol ID
- THT002-PFKV01
- Status last verified
- Oct 2022
- First submitted
- 9 May 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Kavalactones on Sleep and Cortisol in a Cohort of Healthy Adult Males Preparing for Military Special Forces Training
- ClinicalTrials.gov ID
- NCT05381025
- Acronym / sponsor ID
- THT002-PFKV01
- Conditions
- Sleep
- Keywords
- Sleep, Kava, Piper methysticum, Stress, Cortisol, Special Operations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Thorne HealthTech, IncIndustry (pharma, biotech, devices)
- Collaborators
- Performance First
- Study start
- 11 May 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 9 Oct 2022 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active to Placebo (Cohort 1) | Experimental | Dietary Supplement: Kava (Piper methysticum) extractParticipants 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. |
| Placebo to Active (Cohort 2) | Experimental | Dietary Supplement: Kava (Piper methysticum) extractParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Provides consent to participate in the study
- Understands and agrees to follow all study procedures and limitations
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kava (Piper methysticum) extractEach dose (3 capsules) contains kavalactones (225 mg) and silicified microcrystalline cellulose. | Dietary supplement | Active to Placebo (Cohort 1), Placebo to Active (Cohort 2) |
Primary outcome
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].
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].
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.
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.
4 secondary outcomes
Change in General Mood - Phase 1
Time frame: Day 1, 8, and 15
Change in General Mood - Phase 2
Time frame: Day 1, 8, and 15
Change in Motivation and Volition - Phase 1
Time frame: Day 1, 8, and 15
Change in Motivation and Volition - Phase 2
Time frame: Day 1, 8, and 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Schmidt, PhD, MPhil principal investigator
Advanced Pattern Analysis & Countermeasures Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kava (Piper methysticum) extract in people with Sleep, run by Thorne HealthTech, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Salivary Cortisol - Phase 1 (time frame: Day 1 and 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.