A Study of Oral Kavalactones Effect on Nurses

NCT06177535 | Active Not Recruiting

• 1 other identifier: 23-005268
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Keywords

Nursing Professionals

Outcome Measures

Primary Outcomes (1)

• Changes in Cortisol

  Blood serum cortisol levels reported in micrograms per deciliter (mcg/dL)

  Baseline, 4 weeks

Secondary Outcomes (8)

• Change in burnout

  Baseline, 4 weeks

• Change in motivation

  Baseline, 4 weeks

• Change in mood

  Baseline, 4 weeks

• Change in sleep

  Baseline, 4 weeks

• Change in quality of life

  Baseline, 4 weeks

Study Arms (2)

Kava Group

EXPERIMENTAL

Subjects will receive Kavalactones for 28 days

Dietary Supplement: Kavalactones

Placebo Group

PLACEBO COMPARATOR

Subjects will receive placebo for 28 days

Drug: Placebo

Interventions

Placebo DRUG

Three capsules orally once daily within one hour of bedtime. Looks exactly like the study drug, but it contains no active ingredient.

Placebo Group

Kavalactones DIETARY_SUPPLEMENT

Three 75 mg capsules orally once daily within one hour of bedtime (225 mg total/day)

Kava Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Brent Bauer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: August 5, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)