Status:
RECRUITING
A Study of Oral Kavalactones Effect on Nurses
Lead Sponsor:
Mayo Clinic
Conditions:
Stress
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- 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.
Key Trial Info
Start Date :
August 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06177535
Start Date
August 5 2024
End Date
July 31 2026
Last Update
November 24 2025
Active Locations (1)
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1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905