A study with healthy adults to compare how the body processes a dose of two different Kava root products
| ISRCTN | ISRCTN10054466 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10054466 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | B05-25-01-T0082 |
| Sponsor | Botanic Tonics, LLC |
| Funder | Jerry Ross |
- Submission date
- 24/10/2025
- Registration date
- 05/11/2025
- Last edited
- 04/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study is looking at how two different types of kava root products behave in the body after a single dose. Kava is a plant traditionally used in the South Pacific to help with stress and anxiety. It’s now used in other parts of the world too. Researchers want to compare a traditional kava drink made from dried roots with a kava paste extract used in a U.S. product. The goal is to understand how each type is absorbed and processed in the body, and to check if they are safe.
Who can participate?
Healthy adults aged 21 to 55 years can take part in the study.
What does the study involve?
Participants will try both kava products, one at a time, with a break of about 2 to 3 weeks in between. They’ll be randomly assigned to start with one product and then switch to the other. The study includes several visits over a period of 3 to 8 weeks.
What are the possible benefits and risks of participating?
There are no direct personal benefits from taking part. However, the study may help improve understanding of how kava works and how safe it is. As with any study, there may be some side effects or health risks, which will be carefully monitored.
Where is the study run from?
ApexTrials, Canada.
When is the study starting and how long is it expected to run for?
October 2025 to December 2025
Who is funding the study?
Jerry Ross
Who is the main contact?
Dr Anthony Bier, MD., abier@apextrials.com
Contact information
Scientific
120 Research Lane
Guelph
N1G 0B4
Canada
| Phone | +1 519-341-3367 |
|---|---|
| sgirard@nutrasource.ca |
Principal investigator
Suite 101
120 Research Street
Guelph
N1G 0B4
Canada
| Phone | +1 226-706-2545 |
|---|---|
| abier@apextrials.com |
Public
120 Research Lane
Guelph
N1G 0B4
Canada
| Phone | +1 5193413367 |
|---|---|
| chaiashi@nutrasource.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized open-label single-center 2-period crossover study |
| Secondary study design | Randomised cross over trial |
| Scientific title | A randomized, open-label, 2-period crossover study in healthy participants to compare the single dose pharmacokinetics of two kava root products |
| Study objectives | 1. To compare the single dose PK profiles of two(2) Kava root products. 2. To assess the safety of a single dose of two (2) Kava root products |
| Ethics approval(s) |
Approved 16/10/2025, Sterling IRB (5500 Interstate North Pkwy Ste 515, Atlanta, GA 30328, United States of America; +1-888-636-1062; selam.ghebru@sterlingirb.com), ref: 14526 |
| Health condition(s) or problem(s) studied | Pharmacokinetics study in healthy adults |
| Intervention | Study Duration: The entire study duration for each participant in each arm is approximately 3-8 weeks. a. Screening period up to 28 days b. 2 PK visits per test period (Periods A and B; PK Day 1 is approximately 14 hours; PK Day 2 is approximately 1 hour) c. A washout period between test periods of 14 to 24 days Follow-up Duration: The study is considered completed at the last study visit for the last participant or 30 days after the onset of last ongoing AE, whichever is later. A Randomization Scheme is prepared by CRO based on a computer-generated algorithm (SAS). Each participant’s study product assignments will be associated with a unique code to prevent unblinding. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
1. Area under the plasma concentration-time curve from time zero to last measurable concentration (AUC₀–t) for kavalactones is measured using validated LC-MS/MS assay at Visit 2, Visit 3, Visit 4, and Visit 5 |
| Key secondary outcome measure(s) |
Safety outcome measures: |
| Completion date | 25/12/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 44 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Adults who are 21 to 55 years of age (inclusive). 2. In good general health (i.e., no uncontrolled diseases or conditions) as deemed by the investigator (based on review of medical history, vital signs, laboratory safety tests, and physical examination performed at screening and/or before the first dose of study product). 3. Are able to consume the study product completely within the specified timeframe. 4. Not currently using, defined as ≤ 3 uses in the past 3 months prior to Visit 2, any nicotine-containing products (patches, gums, vapes, etc.), kava products, and/or kratom products, and willing to abstain starting 14 days prior to Visit 2 and throughout the study. 5. Have a BMI between 18.5 to 29.9 kg/m² (inclusive) and a body weight of ≥ 50 kg at screening and baseline (Visit 2). 6. Agree not to donate blood until 3 months after the study completion. 7. Must have suitable veins for repeated venipuncture. 8. Have maintained consistent dietary habits, including supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study. 9. Agree to follow the restrictions on concomitant treatments 10. Agree to follow the restrictions on lifestyle 11. Agree to use acceptable contraceptive methods 12. Willing and able to agree to the requirements of this study, be willing to give voluntary consent, and carry out all study-related procedures. |
| Key exclusion criteria | 1. Individuals who are lactating, pregnant, or planning to become pregnant during the study or demonstrate a positive pregnancy test at Visits 1 or 2. 2. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients. 3. Demonstrates a positive urine drug screen test at Visits 1 or 2, a positive urine cotinine test at Visit 2, or a positive breath alcohol test at Visit 2. 4. Individuals with an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea). 5. Screening laboratory results showing liver enzyme levels [Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), Gamma-Glutamyl Transferase (GGT), total bilirubin] that are ≥ 2 times the upper limit of normal, or any other clinically significant abnormal safety laboratory values as per the Investigator’s discretion. 6. Have Type I/II diabetes, high (≥140 systolic or ≥90 diastolic mmHg) or low (<90 systolic or <60 diastolic mmHg) BP at Visit 2, or thyroid disease. 7. Have a history of heart disease, blood clotting disorders, renal or hepatic impairment/disease, seizure disorders, epilepsy, or neurological disease. 8. Have known genetic polymorphisms of CYP450 enzymes, including CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2B6, and/or CYP3A4. 9. Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn’s disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency). 10. Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer), unless recovery occurred more than 5 years before the screening visit. 11. Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.). 12. Reports significant blood loss or blood donation totaling between 101 mL and 449 mL of blood within 30 days prior to Visit 2 or a blood donation of more than 450 mL within 56 days prior to Visit 2. 13. Reports donating plasma (e.g., plasmapheresis) within 15 days prior to Visit 2. 14. Major surgery in the 3 months prior to screening or planned major surgery during the study. 15. Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an inpatient or outpatient intervention program) or use that, in the opinion of the investigator, may be of a concern for the study. 16. Currently consumes more than 2 standard alcoholic beverages a day. Note: A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of liquor. 17. Current enrollment or past participation in another study with any product(s) with at least one active ingredient within 28 days before the first dose of study product or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of the current study. 18. Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant. |
| Date of first enrolment | 17/10/2025 |
| Date of final enrolment | 30/11/2025 |
Locations
Countries of recruitment
- Canada
Study participating centre
Guelph
N1G 0B4
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
27/10/2025: Trial's existence confirmed by Sterling IRB.
