Kava Aging and Mobility Study for Older Adults

This study is testing if a special form of kava, called AB-free kava, can help older adults (age 70 and above) who have trouble sleeping and moving around. AB-free kava is a plant-based supplement that has been changed to remove parts that might cause liver problems. Researchers want to see if taking 225 mg of AB-free kava daily for 8 weeks improves physical function, like walking ability and grip strength, compared to a placebo (a capsule with no active ingredients). They will also look at how AB-free kava affects sleep, stress, and inflammation. The study aims to enroll 40 participants and is currently unclear on its recruitment status.

Study design: This is an interventional study where 40 participants will be randomly assigned to receive either AB-free kava or a placebo. It is double-blind, meaning neither you nor the researchers will know which treatment you are receiving.
What's involved: You would take capsules daily for 8 weeks and attend visits at the start, 4 weeks, and 8 weeks. At these visits, researchers will assess your walking ability, grip strength, and sleep, and collect blood and hair samples.
Compensation: Not stated in the trial record.
Follow-up: Your mobility, physical function, and grip strength will be measured at 4 weeks and at the end of the 8-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Kava Aging and Mobility Study

Not Yet Recruiting

EARLY_PHASE1Ages 70+InterventionalTreatment

University of Florida

~40 participants

Updated 2026-07-23 on ClinicalTrials.gov

What's tested:AB-free kavaPlacebo

At a glance

Recruiting sites

0 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

400-meter walk test

Measured over From baseline to 4 weeks, and again to the end of treatment at 8 weeks.

+2 more outcomes measured

Conditions

Old Adults

Sleep Quality

Kava

Mobility Impairment

Physical Activity and Stress

Physical Impairment

Sedentary Lifestyle in Patients Over 70

Where it's being run

2 sites across 1 states

Florida2

Who to contact

Chengguo Xing, PhD

[email protected]

(352) 294-8511

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

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

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

What this trial measures

400-meter walk testFrom 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)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 StrengthFrom 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.

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