RECRUITING

A Study of Oral Kavalactones Effect on Nurses

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effect of Oral Kavalactones on Cortisol, Measures of Burnout, and Motivation in Nurses

Quick Facts

Study Start:2025-07-15

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06177535

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Jennifer Soderlind

CONTACT

507-284-4799

Soderlind.Jennifer@mayo.edu

Principal Investigator

Brent Bauer, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Brent Bauer, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-15

Study Completion Date2025-10

Study Record Updates

Study Start Date2025-07-15

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

Nursing Professionals

Additional Relevant MeSH Terms

Stress