Kava for Mobility Impairment

Not yet recruiting at 1 trial location

Overseen By Chengguo Xing, PhD

Age: 65+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Florida

Must not be taking: Antidepressants, Antipsychotics, Aricept

Disqualifiers: Diabetes, Liver disease, Cancer, others

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special type of kava, called AB-free kava, can help older adults with sleep difficulties improve physical function and mobility. Researchers aim to determine if this kava also affects sleep, stress, or cell activity. Participants will receive either AB-free kava or a placebo (a treatment with no real effect) to compare outcomes. Ideal candidates are those over age 70 with sleep issues and mild physical difficulties, who are not very active in daily life. As an Early Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

Will I have to stop taking my current medications?

If you are currently using antidepressants, antipsychotic agents, or medications containing acetaminophen, you will need to stop taking them to participate in this trial. Additionally, if you are using any form of kava, you must stop for a 2-week period before joining the study.

Is there any evidence suggesting that AB-free kava is likely to be safe for humans?

Research has shown that AB-free kava is generally safe. The World Health Organization (WHO) and other groups have found that liver problems associated with kava are very rare, indicating that AB-free kava is usually safe to use. Studies suggest that any side effects from AB-free kava are mild, with negative reactions being not serious. This makes it a promising option for improving sleep and physical function, especially in older adults. Although the trial remains in its early stages, these findings offer reassurance about the safety of AB-free kava for potential participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for mobility impairment, which often involve physical therapy or medications targeting symptoms, AB-free kava is derived from the kava plant and offers a natural alternative. Researchers are excited about this treatment because it potentially enhances mobility by targeting the nervous system without the presence of aristolactams, which may reduce the risk of harmful side effects associated with traditional kava. This approach not only promises a novel mechanism of action but also aims to provide a safer option for those seeking relief from mobility challenges.

What evidence suggests that AB-free kava might be an effective treatment for mobility impairment?

Research shows that AB-free kava, which participants in this trial may receive, might improve movement and physical function by reducing stress and inflammation. Early lab and small-scale studies suggest it can also enhance sleep quality, important for overall health and maintaining activity levels. The treatment's support for physical activity may stem from its stress-reducing effects. Although limited research exists on humans, these early findings are promising and suggest potential benefits for older adults with mobility issues. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for older adults who have trouble moving around and sleeping well. They should be generally inactive, experiencing mobility impairment, insomnia, or stress related to limited physical activity. Participants must not currently use kava.

Inclusion Criteria

Insomnia severity index (ISI) between 8 and 21

Sedentary lifestyle (< 150 min per week of moderate intensity physical activity) verified by CHAMPS questionnaire

Availability for participation through duration of study

Exclusion Criteria

Failure to provide informed consent

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either AB-free kava or placebo daily for 8 weeks to assess improvements in mobility, sleep, and stress

8 weeks

3 visits (in-person) at baseline, week 4, and week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AB-free kava

Trial Overview The study tests if AB-free kava can improve how easily older adults with sleep issues move and function physically. It compares the effects of AB-free kava with a placebo to see any differences in mobility, sleep quality, stress levels, and cellular responses.

How Is the Trial Designed?

Group I: AB-free Kava Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07219186

NCT07219186 | Kava Aging and Mobility Study Early lab and pilot studies suggest AB-free kava may help improve sleep, reduce stress, decrease inflammation, and support physical activity.

2. withpower.com withpower.com/trial/early-phase-1-sedentary-lifestyle-in-patients-over-70-2026-3cb22

Kava for Mobility Impairment · Info for Participants 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11555507/

Flavokavains A- and B-Free Kava Enhances Resilience ... These data overall support the promising safety profiles of AB-free kava under the current treatment regimen in A/J mice, again consistent ...

4. researchgate.net researchgate.net/publication/385653395_Flavokavains_A-_and_B-Free_Kava_Enhances_Resilience_against_the_Adverse_Health_Effects_of_Tobacco_Smoke_in_Mice?_tp=eyJjb250ZXh0Ijp7InBhZ2UiOiJzY2llbnRpZmljQ29udHJpYnV0aW9ucyIsInByZXZpb3VzUGFnZSI6bnVsbCwic3ViUGFnZSI6bnVsbH19

Flavokavains A- and B-Free Kava Enhances Resilience ... 6,7 Our prior preclinical research demonstrated the potential of AB-free kava in mitigating several tobacco smoke-related health issues.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11662815/

The potential of AB-free kava in enabling tobacco ... AB-free kava is a novel and promising intervention to facilitate tobacco cessation via its holistic effects associated with managing stress and insomnia during ...

6. pubs.acs.org pubs.acs.org/doi/10.1021/acsptsci.4c00415

Flavokavains A- and B-Free Kava Enhances Resilience ... AB-free kava has the potential to reduce tobacco-smoking-induced lung cancer risk, mitigate tobacco dependence, and reduce tobacco use.

7. researchgate.net researchgate.net/publication/387304195_The_potential_of_AB-free_kava_in_enabling_tobacco_cessation_via_management_of_abstinence-related_stress_and_insomnia_study_protocol_for_a_randomized_clinical_trial

(PDF) The potential of AB-free kava in enabling tobacco ... We hypothesize that AB-free kava is a novel and promising intervention to facilitate tobacco cessation via its holistic effects associated with ...