Clinical trial NCT06177535: A Study of Oral Kavalactones Effect on Nurses
Official title: The Effect of Oral Kavalactones on Cortisol, Measures of Burnout, and Motivation in Nurses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Keywords: Nursing Professionals
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Changes in Cortisol
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Change in burnout
timeFrame: Baseline, 4 weeks
measure: Change in motivation
timeFrame: Baseline, 4 weeks
measure: Change in mood
timeFrame: Baseline, 4 weeks
measure: Change in sleep
timeFrame: Baseline, 4 weeks
measure: Change in quality of life
timeFrame: Baseline, 4 weeks
measure: Change in stress
timeFrame: Baseline, 4 weeks
measure: Change in cognition
timeFrame: Baseline, 4 weeks
measure: Adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Brent Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References: