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.
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)
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
University of Florida
Lead sponsor
National Institute on Aging (NIA)
Collaborator