Old AdultsEarly Phase 1NCT07219186
Kava Aging and Mobility Study
A Early Phase 1 study testing AB-free kava in people with Old Adults and Sleep Quality, run by University of Florida at 2 sites in United States.
Trial summary
The goal of this clinical trial is to learn if AB-free kava works to improve mobility and physical function in older adults with sleep difficulties. It will also learn about the safety of AB-free kava. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Old Adults, Sleep Quality, Kava
- What is being tested?
- AB-free kava
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2026to 30 Jun 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age > 70 years
- 8 ≤ Insomnia severity index (ISI) ≤21
- 4m walking speed <1 m/sec and >0.44 m/sec
- Mild to moderate physical impairment (Short Physical Performance Battery score < 10)
- Sedentary lifestyle (< 150 min per week of moderate intensity physical activity) verified by CHAMPS questionnaire
- Willingness and ability to give informed consent
Show all 24Show fewer
- Willingness to be randomized to the intervention groups
- Availability for participation through duration of study Exclusion Criteria (General)
- Failure to provide informed consent
- History or clinical manifestation of diabetes, cholelithiasis, liver or renal disease, cancer, or progressive, degenerative neurologic disease (e.g., Parkinson's Disease, multiple sclerosis, ALS)
- Abnormal laboratory markers (e.g., renal or liver abnormalities, elevated potassium levels, or hemoglobin and hematocrit below the lower limit of normal)
- Residence in a Skilled Nursing Facility (SNF); residence in an Assisted Living Facility (ALF) or independent housing is allowed
- Self-reported inability to walk one block
- Significant cognitive impairment, defined as a known diagnosis of dementia or a Mini-Mental Status Exam score < 24
- Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active inflammatory disease)
- Terminal illness with life expectancy less than 12 months, as determined by a physician
- Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
- Severe pulmonary disease, pneumonitis or interstitial lung disease
- Other significant co-morbid disease (e.g. renal failure on hemodialysis) or severe psychiatric disorder (e.g. bipolar, schizophrenia)
- Current use of antidepressant medications, antipsychotic agents, monoamine oxidase inhibitors, anticholinesterase inhibitors (i.e., Aricept)
- Refuses to reduce alcohol use to 3 or fewer alcoholic drinks per week during the study
- Planning to permanently leave the area in the next year
- Blood pressure readings >180/100 at screening
- Participating in another clinical trial or has received an investigational product within 30 days prior to screening/enrollment.
Who cannot join
- Regular use of any medications that contain acetaminophen
- Current use of any forms of kava and not willing to stop for a 2-week washout period - dietary supplements or beverages
- Current use of antidepressant medications and antipsychotic agents (including monoamine oxidase inhibitors), or anticholinesterase inhibitors (i.e., Aricept)
- Diagnosed with liver dysfunction or with previous liver diseases during the past five years
- Levels of ALT, AST, ALP or total bilirubin over 3xlimit of normal (ULN) range at prescreen
- Temporary Exclusion Criteria
Show all 11Show fewer
- Acute infection (urinary, respiratory, other) or hospitalization within 1 month
- Myocardial infarction, CABG, or valve replacement within past 6 months
- Pulmonary embolism or deep venous thrombosis within past 6 months
- Stroke, hip fracture, hip or knee replacement, or spinal surgery within past 4 months
- Receiving physical therapy for gait, balance, or other lower extremity training
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Institute on Aging University of Florida
Gainesville, Florida, 32610
Stephen D. Anton, Ph.D.
Institute on Aging Unversity of Florida
Gainesville, Florida, 32610
Christian W. McLaren, M.S., 863-263-7867, mclaren@ufl.edu
Nevena Stanojevic, B.S., (352) 294-5824, nevenastanojevic@ufl.edu
About this study
Official title: Impacts of AB-free Kava on Mitigating Mobility Loss With Aging: A Pilot Study
The goal of this clinical trial is to learn if AB-free kava works to improve mobility and physical function in older adults with sleep difficulties. It will also learn about the safety of AB-free kava. The main questions it aims to answer are:
- Does AB-free kava improve physical function and/or mobility?
- Does AB-free kava effect sleep, stress, or cellular signaling? Researchers will compare AB-free kava to a placebo (a look-alike substance that contains no drug) to see if AB-free kava works to improve mobility and physical functioning.
Read the detailed description
This research study is testing whether a specially prepared form of kava, a traditional plant-based supplement, can help improve mobility, sleep, and stress in older adults. Kava has been used safely for centuries in the South Pacific as a natural remedy for relaxation and better sleep, but some modern versions raised safety concerns due to rare liver problems. Researchers have developed a safer version called "AB-free kava," which removes compounds (flavokavains A and B) believed to cause liver issues. Early lab and pilot studies suggest AB-free kava may help improve sleep, reduce stress, decrease inflammation, and support physical activity. This pilot clinical trial will enroll 40 sedentary adults age 70+ who have sleep difficulties. Participants will be randomly assigned to receive either AB-free kava (225 mg/day) or a placebo daily for 8 weeks. The study is double-blind, meaning neither participants nor researchers will know which treatment each person is receiving. Participants will complete visits at the start, midpoint (week 4), and end (week 8) of the study. At each visit, researchers will assess walking ability, grip strength, and sleep quality using wearable activity trackers and validated questionnaires. Blood and hair samples will be collected to measure stress hormones and inflammation. Participants will be screened for eligibility based on age, sleep problems, mobility, and general health. Those with significant health conditions, cognitive impairments, or certain medication use will not be eligible. The study aims to test whether AB-free kava is safe, acceptable, and potentially beneficial for improving sleep and physical function in older adults. If results are promising, this could lead to future larger studies testing AB-free kava as a natural option to support healthy aging.
- Conditions
- Old Adults, Sleep Quality, Kava, Mobility Impairment, Physical Activity and Stress, Physical Impairment
- Being tested
- AB-free kava, Placebo
- Keywords
- AB-free Kava, Old adults, Sleep Difficulties, Mobility Limitations
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Motor Activity, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-free kavaDrug
AB-free kava (75mg kavalactones per capsule, for a total of 225 mg/day)
PlaceboOther
Participants will consume microcrystalline cellulose in capsules identical to AB-free kava, which will be provided by Thorne Research. There are no active ingredients in the placebo capsules.
| Study group | Role | What they receive |
|---|---|---|
| AB-free Kava | Experimental | Not described Receives: Drug: AB-free kava |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
400-meter walk test
400-m walk test is a feasible, objective, reliable, well-validated measure to assess mobility and is commonly used in large clinical trials. Participants will be asked to walk 400 m at their usual pace, without overexerting, on a 20-m course for 10 laps (40 m/lap). Participants will be allowed to use a cane, but not a walker, to complete this test.
Measured: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Short Physical Performance Battery (SPPB)
SPPB will be used to assess physical performance, which is based on a timed 4-m walk, balance and chair stand tests with a range from 0 (worst performers) to 12 (best performers). This scale is reliable and valid for predicting institutionalization, mortality and disability SPPB will be administered by a trained and certified examiner.
Measured: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Grip Strength
Grip strength test will be used to measure muscle strength and has been widely used as a general indicator of functional status. Grip strength will be measured using the Jammar dynamometer.
Measured: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Secondary outcomes (14)
Insomnia Severity Index (ISI)
Insomnia Severity Index (ISI) will be used to characterize sleep disturbances and measure the severity of insomnia during the trial.
Measured: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available) to assess the quality of sleep.
Measured: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Perceived Stress Scale (PSS)
Perceived Stress Scale (PSS) is a 10-item scale that will measure the perception of stress. It will be used to assess the levels of stress among subjects during the trial and quantity its levels.
Measured: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Montgomery Asberg Depression Rating Scale (MADRS)
Montgomery Asberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale to measure depression. It will be used to monitor subjects for changes in severity of depressive symptoms during the trial.
Measured: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Hair Cortisol
A biomarker used to assess long-term cortisol exposure.
Measured: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
C-reactive protein (CRP)
C-reactive protein (CRP) is an acute-phase protein produced by the liver in response to inflammation. It serves as a biomarker of systemic inflammation, with higher levels indicating infection, tissue injury, or chronic inflammatory conditions such as cardiovascular or metabolic disease.
Measured: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Interleukin-6 (IL-6)
Interleukin-6 (IL-6) is a cytokine that plays a key role in the body's immune response and inflammation, used as a biomarker for systemic inflammation.
Measured: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Tumor necrosis factor-alpha (TNF-α)
Tumor necrosis factor-alpha (TNF-α) is a pro-inflammatory cytokine produced primarily by macrophages and other immune cells, used as a biomarker for systemic inflammation.
Measured: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Total sleep time (TST)
Total sleep time (TST) will be calculated using wrist-based actigraphy. TST will include the amount of time spent asleep while in bed, obtained in minutes.
Measured: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Sleep onset latency (SOL)
Sleep onset latency (SOL) will be obtained using wrist-based actigraphy. SOL measures the amount of time it takes to fall asleep after getting into bed, measured in minutes.
Measured: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Sleep efficiency (SE)
Sleep efficiency (SE) will be measured using a wrist-based actigraphy. SE measures the percent of time in sleep that is actually spent asleep, obtained in minutes.
Measured: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Wake after sleep onset (WASO)
Wake after sleep onset (WASO) will be obtained using a wrist-based actigraphy. WASO represents the amount of time awake after initially falling asleep, measured in minutes.
Measured: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Number of wake bouts
Number of wake bouts will be measured using wrist-based actigraphy. Number of wake up bouts represents the number of times woken up during the night.
Measured: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Sedentary activity (SA)
Sedentary activity (SA) will be measured using wrist-based actigraphy, using wrist cut-points. Counts per minute will be used to quantify time spent in sedentary and non-sedentary styles in older adults
Measured: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start1 Dec 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AdultsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219186
- Sponsor's protocol ID
- 202500956
- Status last verified
- Aug 2026
- First submitted
- 20 Oct 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of AB-free Kava on Mitigating Mobility Loss With Aging: A Pilot Study
- ClinicalTrials.gov ID
- NCT07219186
- Acronym / sponsor ID
- 202500956
- Conditions
- Old Adults, Sleep Quality, Kava, Mobility Impairment, Physical Activity and Stress, Physical Impairment
- Keywords
- AB-free Kava, Old adults, Sleep Difficulties, Mobility Limitations
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 21 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if AB-free kava works to improve mobility and physical function in older adults with sleep difficulties. It will also learn about the safety of AB-free kava. The main questions it aims to answer are:
- Does AB-free kava improve physical function and/or mobility?
- Does AB-free kava effect sleep, stress, or cellular signaling? Researchers will compare AB-free kava to a placebo (a look-alike substance that contains no drug) to see if AB-free kava works to improve mobility and physical functioning.
Detailed description
This research study is testing whether a specially prepared form of kava, a traditional plant-based supplement, can help improve mobility, sleep, and stress in older adults. Kava has been used safely for centuries in the South Pacific as a natural remedy for relaxation and better sleep, but some modern versions raised safety concerns due to rare liver problems. Researchers have developed a safer version called "AB-free kava," which removes compounds (flavokavains A and B) believed to cause liver issues. Early lab and pilot studies suggest AB-free kava may help improve sleep, reduce stress, decrease inflammation, and support physical activity. This pilot clinical trial will enroll 40 sedentary adults age 70+ who have sleep difficulties. Participants will be randomly assigned to receive either AB-free kava (225 mg/day) or a placebo daily for 8 weeks. The study is double-blind, meaning neither participants nor researchers will know which treatment each person is receiving. Participants will complete visits at the start, midpoint (week 4), and end (week 8) of the study. At each visit, researchers will assess walking ability, grip strength, and sleep quality using wearable activity trackers and validated questionnaires. Blood and hair samples will be collected to measure stress hormones and inflammation. Participants will be screened for eligibility based on age, sleep problems, mobility, and general health. Those with significant health conditions, cognitive impairments, or certain medication use will not be eligible. The study aims to test whether AB-free kava is safe, acceptable, and potentially beneficial for improving sleep and physical function in older adults. If results are promising, this could lead to future larger studies testing AB-free kava as a natural option to support healthy aging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB-free Kava | Experimental | Drug: AB-free kava |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (24 listed)
- Age > 70 years
- 8 ≤ Insomnia severity index (ISI) ≤21
- 4m walking speed <1 m/sec and >0.44 m/sec
- Mild to moderate physical impairment (Short Physical Performance Battery score < 10)
- Sedentary lifestyle (< 150 min per week of moderate intensity physical activity) verified by CHAMPS questionnaire
Key exclusion criteria (11 listed)
- Regular use of any medications that contain acetaminophen
- Current use of any forms of kava and not willing to stop for a 2-week washout period - dietary supplements or beverages
- Current use of antidepressant medications and antipsychotic agents (including monoamine oxidase inhibitors), or anticholinesterase inhibitors (i.e., Aricept)
- Diagnosed with liver dysfunction or with previous liver diseases during the past five years
- Levels of ALT, AST, ALP or total bilirubin over 3xlimit of normal (ULN) range at prescreen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB-free kavaAB-free kava (75mg kavalactones per capsule, for a total of 225 mg/day) | Drug | AB-free Kava |
| PlaceboParticipants will consume microcrystalline cellulose in capsules identical to AB-free kava, which will be provided by Thorne Research. There are no active ingredients in the placebo capsules. | Other | Placebo |
Primary outcome
400-meter walk test
Time frame: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
400-m walk test is a feasible, objective, reliable, well-validated measure to assess mobility and is commonly used in large clinical trials. Participants will be asked to walk 400 m at their usual pace, without overexerting, on a 20-m course for 10 laps (40 m/lap). Participants will be allowed to use a cane, but not a walker, to complete this test.
Short Physical Performance Battery (SPPB)
Time frame: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.
SPPB will be used to assess physical performance, which is based on a timed 4-m walk, balance and chair stand tests with a range from 0 (worst performers) to 12 (best performers). This scale is reliable and valid for predicting institutionalization, mortality and disability SPPB will be administered by a trained and certified examiner.
Grip Strength
Time frame: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Grip strength test will be used to measure muscle strength and has been widely used as a general indicator of functional status. Grip strength will be measured using the Jammar dynamometer.
14 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Perceived Stress Scale (PSS)
Time frame: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Hair Cortisol
Time frame: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
C-reactive protein (CRP)
Time frame: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Interleukin-6 (IL-6)
Time frame: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Tumor necrosis factor-alpha (TNF-α)
Time frame: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Total sleep time (TST)
Time frame: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Sleep onset latency (SOL)
Time frame: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Sleep efficiency (SE)
Time frame: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Wake after sleep onset (WASO)
Time frame: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Number of wake bouts
Time frame: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Sedentary activity (SA)
Time frame: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AB-free kava in people with Old Adults and Sleep Quality, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chengguo Xing, PhD ((352) 294-8511, chengguoxing@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
400-meter walk test (time frame: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.