NCT07219186

Kava Aging and Mobility Study

Impacts of AB-free Kava on Mitigating Mobility Loss With Aging: A Pilot Study

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

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 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, decrease inflammation, and support physical activity. This pilot clinical trial will enroll 40 sedentary adults age 70+ who have sleep difficulties. Participants will be randomly assigned to receive either AB-free kava (225 mg/day) or a placebo daily for 8 weeks. The study is double-blind, meaning neither participants nor researchers will know which treatment each person is receiving. Participants will complete visits at the start, midpoint (week 4), and end (week 8) of the study. At each visit, researchers will assess walking ability, grip strength, and sleep quality using wearable activity trackers and validated questionnaires. Blood and hair samples will be collected to measure stress hormones and inflammation. Participants will be screened for eligibility based on age, sleep problems, mobility, and general health. Those with significant health conditions, cognitive impairments, or certain medication use will not be eligible. The study aims to test whether AB-free kava is safe, acceptable, and potentially beneficial for improving sleep and physical function in older adults. If results are promising, this could lead to future larger studies testing AB-free kava as a natural option to support healthy aging.

Conditions

• Old Adults
• Sleep Quality
• Kava
• Mobility Impairment
• Physical Activity and Stress
• Physical Impairment
• Sedentary Lifestyle in Patients Over 70

Interventions

Type	Name	Description
DRUG	AB-free kava	AB-free kava (75mg kavalactones per capsule, for a total of 225 mg/day)
OTHER	Placebo	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-03-01
• Completion: 2027-05-01
• First posted: 2025-10-21
• Last updated: 2026-02-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study