A Study of Oral Kavalactones Effect on Nurses

Mayo Clinic

Status: Enrolling

Conditions: Stress

Treatments: Dietary Supplement: Kavalactones; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06177535

23-005268

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Kava Group

Experimental group

Description:

Subjects will receive Kavalactones for 28 days

Treatment:

Dietary Supplement: Kavalactones

Placebo Group

Placebo Comparator group

Description:

Subjects will receive placebo for 28 days

Treatment:

Drug: Placebo