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Active (not recruiting) Not applicable NCT06177535

A Study of Oral Kavalactones Effect on Nurses

No applicable phase (e.g. observational)
Conditions: Stress

Sponsor: Mayo Clinic

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Overview
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.
Who can participate
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.
Interventions
Kavalactones
DIETARY_SUPPLEMENT
Placebo
DRUG
Locations 1
United States (1)
Mayo Clinic Minnesota
Rochester , Minnesota
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
05.08.2024
Completion date
30.06.2026
Registry ID
NCT06177535
Source
clinicaltrials.gov
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