StressNCT06177535
A Study of Oral Kavalactones Effect on Nurses
A study testing Kavalactones in people with Stress, run by Mayo Clinic at 1 site in United States.
Trial summary
This research study is being done to assess the impact of taking Kava extract (Piper methysticum), a dietary supplement on cortisol in a healthy nursing population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Kavalactones
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Surgical services nurses at Mayo Clinic in Rochester, MN.
- Able to participate fully in all aspects of the study.
- Willing to use birth control for the duration of the study (if of childbearing potential).
- Understood and signed study informed consent.
Who cannot join
- Pregnant, nursing, or trying to conceive.
- Persons with a menstrual cycle who are not willing and able to use an approved contraceptive during the study (female sterilization (tubal ligation, hysterectomy), IUD or another implant, oral or injectable contraceptive, contraceptive patch/ring, diaphragm/cervical cap, male sterilization (vasectomy), male condom, female condom, sponge/spermicide) (Persons who do not have sex with men can participate without the use of an approved contraceptive).
- Use of kava or kava-containing products within the past 8 weeks.
- Any prior adverse reaction or known sensitivity or allergy to kava or related botanicals (peppers).
- Use of acetaminophen that cannot be discontinued or replaced with an NSAID during the study.
- Use of oral corticosteroids (e.g., hydrocortisone) or other steroids (e.g., prednisone).
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- Alcohol use greater than 1 drink per day.
- Use of kratom within the past 8 weeks.
- Recent history of clinical depression or anxiety diagnosis.
- Known significant liver disease or dysfunction.
- Known significant kidney disease or dysfunction.
- Known Addison's or Cushing's Disease.
- Known catecholamine imbalance or medication use which influences catecholamine levels.
- History or current diagnosis of cancer (except for successfully treated basal cell carcinoma diagnosed less than 5 years prior to screening or cancer in full remission more than 5 years after diagnosis).
- Recent history or acute disease or unstable medical condition.
- Surgery planned during the course of the trial.
- A known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Kavalactones on Cortisol, Measures of Burnout, and Motivation in Nurses
This research study is being done to assess the impact of taking Kava extract (Piper methysticum), a dietary supplement on cortisol in a healthy nursing population.
- Conditions
- Stress
- Being tested
- Kavalactones, Placebo
- Keywords
- Nursing Professionals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KavalactonesDietary supplement
Three 75 mg capsules orally once daily within one hour of bedtime (225 mg total/day)
PlaceboDrug
Three capsules orally once daily within one hour of bedtime. Looks exactly like the study drug, but it contains no active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Kava Group | Experimental | Subjects will receive Kavalactones for 28 days Receives: Dietary Supplement: Kavalactones |
| Placebo Group | Placebo comparator | Subjects will receive placebo for 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cortisol
Blood serum cortisol levels reported in micrograms per deciliter (mcg/dL)
Measured: Baseline, 4 weeks
Secondary outcomes (8)
Change in burnout
Measured using the Maslach Burnout Inventory-Human Services Survey for Medical Personnel - MBI-HSS (MP): The MBI-HSS (MP) addresses three scales: Emotional Exhaustion measures feelings of being emotionally overextended and exhausted by one's work; Depersonalization measures an unfeeling and impersonal response toward patients; Personal Accomplishment measures feelings of competence and successful achievement in one's work.
Measured: Baseline, 4 weeks
Change in motivation
Measured using the Cravings for Rest and Volitional Energy Expenditure (CRAVE) survey developed to measure motivation states for physical activity and sedentary behaviors. Subjects indicate how much they want or desire to perform activities by circling the number along each line between 0 (not at all) and 10 (more than ever).
Measured: Baseline, 4 weeks
Change in mood
Measured using the Depression, Anxiety and Stress Scale - 21 Items (DASS-21). The DASS-21 is a non-diagnostic, validated instrument to assess perceived levels of depressed, stressed, or anxious emotional states over the past seven days. Scores for each state range from 0-42 and can be summed to generate a total score reflecting overall negative mood.
Measured: Baseline, 4 weeks
Change in sleep
Measured using the PROMIS Sleep Disturbance -Short Form 6a to assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep.
Measured: Baseline, 4 weeks
Change in quality of life
Measured using the Linear Analogue Self-Assessment (LASA) - LASA-1 single item Likert scale of 10 points (0-10) which measures quality of life, with higher score indicating better quality of life.
Measured: Baseline, 4 weeks
Change in stress
Measured using The Perceived Stress Scale-10 (PSS) that elicits self-reported personal stress levels. The scores range from 0-40, with higher scores indicating more severe stress.
Measured: Baseline, 4 weeks
Change in cognition
Measured using CNS Vital Signs in-office neurocognitive testing, a non-invasive clinical procedure to efficiently and objectively assess a broad spectrum of brain function performance or domains under challenge (cognition stress test).
Measured: Baseline, 4 weeks
Adverse events
Number of adverse events reported
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start5 Aug 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent A. Bauer, Mayo Clinic
- Investigators
- Brent Bauer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177535
- Sponsor's protocol ID
- 23-005268
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2023
- Last updated
- 14 Jul 2026
- 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Kavalactones on Cortisol, Measures of Burnout, and Motivation in Nurses
- ClinicalTrials.gov ID
- NCT06177535
- Acronym / sponsor ID
- 23-005268
- Conditions
- Stress
- Keywords
- Nursing Professionals
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 20 Dec 2023 (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 assess the impact of taking Kava extract (Piper methysticum), a dietary supplement on cortisol in a healthy nursing population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kava Group | Experimental | Dietary Supplement: KavalactonesSubjects will receive Kavalactones for 28 days |
| Placebo Group | Placebo comparator | Drug: PlaceboSubjects will receive placebo for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Surgical services nurses at Mayo Clinic in Rochester, MN.
- Able to participate fully in all aspects of the study.
- Willing to use birth control for the duration of the study (if of childbearing potential).
- Understood and signed study informed consent.
Key exclusion criteria (17 listed)
- Pregnant, nursing, or trying to conceive.
- Persons with a menstrual cycle who are not willing and able to use an approved contraceptive during the study (female sterilization (tubal ligation, hysterectomy), IUD or another implant, oral or injectable contraceptive, contraceptive patch/ring, diaphragm/cervical cap, male sterilization (vasectomy), male condom, female condom, sponge/spermicide) (Persons who do not have sex with men can participate without the use of an approved contraceptive).
- Use of kava or kava-containing products within the past 8 weeks.
- Any prior adverse reaction or known sensitivity or allergy to kava or related botanicals (peppers).
- Use of acetaminophen that cannot be discontinued or replaced with an NSAID during the study.
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 |
|---|---|---|
| KavalactonesThree 75 mg capsules orally once daily within one hour of bedtime (225 mg total/day) | Dietary supplement | Kava Group |
| PlaceboThree capsules orally once daily within one hour of bedtime. Looks exactly like the study drug, but it contains no active ingredient. | Drug | Placebo Group |
Primary outcome
Changes in Cortisol
Time frame: Baseline, 4 weeks
Blood serum cortisol levels reported in micrograms per deciliter (mcg/dL)
8 secondary outcomes
Change in burnout
Time frame: Baseline, 4 weeks
Change in motivation
Time frame: Baseline, 4 weeks
Change in mood
Time frame: Baseline, 4 weeks
Change in sleep
Time frame: Baseline, 4 weeks
Change in quality of life
Time frame: Baseline, 4 weeks
Change in stress
Time frame: Baseline, 4 weeks
Change in cognition
Time frame: Baseline, 4 weeks
Adverse events
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Brent Bauer, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kavalactones in people with Stress, run by Mayo Clinic 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 4 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in Cortisol (time frame: Baseline, 4 weeks). 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 14 Jul 2026.