Kava Aging and Mobility Study

Starting soon · Early Phase 1 · Has a placebo group

Conditions studied: Old Adults, Sleep Quality, Kava, Mobility Impairment, Physical Activity and Stress, Physical Impairment, Sedentary Lifestyle in Patients Over 70

In brief

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.

Key facts

Study ID

NCT07219186

Run by

University of Florida

People needed

40

Starts

2027-01-01

Expected to finish

2027-05-01

Last updated by the study team

2026-07-23

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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, 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.
• Exclusion Criteria (AB-free kava-related)

Where it is running

• Institute on Aging University of Florida — Gainesville, Florida, United States
• Institute on Aging Unversity of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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