NCT07219186

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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
10mo left

Started Apr 2026

Shorter than P25 for early_phase_1

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Apr 2026May 2027

First Submitted

Initial submission to the registry

October 20, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

February 2, 2026

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

October 20, 2025

Last Update Submit

January 30, 2026

Conditions

Sleep QualityMobility ImpairmentPhysical Activity and StressPhysical ImpairmentSedentary Lifestyle in Patients Over 70Old AdultsKava

Keywords

AB-free KavaOld adultsSleep DifficultiesMobility Limitations

Outcome Measures

Primary Outcomes (3)

  • 400-meter walk test

    400-m walk test is a feasible, objective, reliable, well-validated measure to assess mobility and is commonly used in large clinical trials. Participants will be asked to walk 400 m at their usual pace, without overexerting, on a 20-m course for 10 laps (40 m/lap). Participants will be allowed to use a cane, but not a walker, to complete this test.

    From baseline to 4 weeks, and again to the end of treatment at 8 weeks.

  • Short Physical Performance Battery (SPPB)

    SPPB will be used to assess physical performance, which is based on a timed 4-m walk, balance and chair stand tests with a range from 0 (worst performers) to 12 (best performers). This scale is reliable and valid for predicting institutionalization, mortality and disability SPPB will be administered by a trained and certified examiner.

    Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks.

  • Grip Strength

    Grip strength test will be used to measure muscle strength and has been widely used as a general indicator of functional status. Grip strength will be measured using the Jammar dynamometer.

    From baseline to 4 weeks, and again to the end of treatment at 8 weeks.

Secondary Outcomes (14)

  • Insomnia Severity Index (ISI)

    From baseline to 4 weeks, and again to the end of treatment at 8 weeks.

  • Pittsburgh Sleep Quality Index (PSQI)

    From baseline to 4 weeks, and again to the end of treatment at 8 weeks.

  • Perceived Stress Scale (PSS)

    From baseline to 4 weeks, and again to the end of treatment at 8 weeks.

  • Montgomery Asberg Depression Rating Scale (MADRS)

    From baseline to 4 weeks, and again to the end of treatment at 8 weeks.

  • Hair Cortisol

    From baseline to 4 weeks, and again to the end of treatment at 8 weeks.

  • +9 more secondary outcomes

Study Arms (2)

AB-free Kava

EXPERIMENTAL
Drug: AB-free kava

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

AB-free kavaDRUG

AB-free kava (75mg kavalactones per capsule, for a total of 225 mg/day)

AB-free Kava
PlaceboOTHER

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.

Placebo

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age \> 70 years
  • ≤ Insomnia severity index (ISI) ≤21
  • m 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

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute on Aging University of Florida

Gainesville, Florida, 32610, United States

Location

Institute on Aging Unversity of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersMotor ActivityMobility Limitation

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Chengguo Xing, PhD

CONTACT

(352) 294-8511chengguoxing@ufl.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2025

First Posted

October 21, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

February 2, 2026

Record last verified: 2025-08

Locations

US(2)