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Kava capsules tested as a mobility aid for seniors over 70

NCT ID NCT07219186

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 4 times

Summary

This pilot study will test whether a special form of kava (AB-free kava) can improve mobility and physical function in adults over 70 who have mild sleep problems and are somewhat inactive. Forty participants will take either kava capsules or a placebo daily for a period, and researchers will measure walking speed, strength, balance, and sleep quality. The goal is to see if this supplement offers a safe way to help older adults stay active and independent.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AB-free kava (a kava extract without potentially harmful compounds)
What this could lead to
If it works, this could point toward a natural supplement to help older adults maintain mobility and sleep quality.
What could go wrong
This is a very early, small pilot study with only 40 participants. It may not show clear benefits, and kava products have been linked to liver concerns in the past.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

70 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

insomnia Mobility Limitation Motor Activity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institute on Aging University of Florida

    Gainesville, Florida, 32610, United States

  • Institute on Aging Unversity of Florida

    Gainesville, Florida, 32610, United States

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