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
Parallel
AB-free kava
DrugAB-free kava (75mg kavalactones per capsule, for a total of 225 mg/day)
Placebo
Other interventionParticipants 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.
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.
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.
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.
Insomnia Severity Index (ISI)
Insomnia Severity Index (ISI) will be used to characterize sleep disturbances and measure the severity of insomnia during the trial.
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.
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.
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.
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University of Florida
Lead sponsor
National Institute on Aging (NIA)
Collaborator
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