Not Yet RecruitingEarly Phase 1

Kava Aging and Mobility Study

United States40 participantsStarted 2026-04

Plain-language 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. 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.

Who can participate

Age range

70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * 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, clinic…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

400-meter walk test

Timeframe: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.

Short Physical Performance Battery (SPPB)

Timeframe: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.

Grip Strength

Timeframe: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.

Trial details

NCT IDNCT07219186

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Chengguo Xing, PhD

(352) 294-8511 chengguoxing@ufl.edu

View on ClinicalTrials.gov More Old Adults trials

Plain-language summary

Who can participate

Age range

70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

400-meter walk test

Timeframe: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.

Short Physical Performance Battery (SPPB)

Timeframe: Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.

Grip Strength

Timeframe: From baseline to 4 weeks, and again to the end of treatment at 8 weeks.