Impacts of AB-free Kava on Mitigating Mobility Loss With Aging: A Pilot Study
University of Florida
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. 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.
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 for centuries in the South Pacific as a natural remedy for relaxation and better sleep, but some modern versions raised safety concerns due to rare liver problems. Researchers have developed a safer version called "AB-free kava," which removes compounds (flavokavains A and B) believed to cause liver issues. Early lab and pilot studies suggest AB-free kava may help improve sleep, reduce stress, dec…
Eligibility
- Age range
- 70+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugAB-free kava
AB-free kava (75mg kavalactones per capsule, for a total of 225 mg/day)
- OtherPlacebo
Participants 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.
Locations (2)
- Institute on Aging University of FloridaGainesville, Florida
- Institute on Aging Unversity of FloridaGainesville, Florida