Status:
NOT_YET_RECRUITING
Kava Aging and Mobility Study
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Old Adults
Sleep Quality
Eligibility:
All Genders
70+ years
Phase:
EARLY_PHASE1
Brief 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...
Detailed Description
This research study is testing whether a specially prepared form of kava, a traditional plant-based supplement, can help improve mobility, sleep, and stress in older adults. Kava has been used safely ...
Eligibility Criteria
Inclusion
- 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, 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)
- 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
- Temporary Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07219186
Start Date
January 1 2026
End Date
January 1 2028
Last Update
October 21 2025
Active Locations (2)
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1
Institute on Aging University of Florida
Gainesville, Florida, United States, 32610
2
Institute on Aging Unversity of Florida
Gainesville, Florida, United States, 32610