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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AB-free Kava | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB-free kava | Drug | AB-free kava (75mg kavalactones per capsule, for a total of 225 mg/day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | Insomnia Severity Index (ISI) will be used to characterize sleep disturbances and measure the severity of insomnia during the trial. | From baseline to 4 weeks, and again to the end of treatment at 8 weeks. |
| Pittsburgh Sleep Quality Index (PSQI) |
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Inclusion Criteria:
Exclusion Criteria (AB-free kava-related)
Temporary Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengguo Xing, PhD | Contact | (352) 294-8511 | chengguoxing@ufl.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute on Aging University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D009043 | Motor Activity |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Placebo |
| Other |
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. |
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Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available) to assess the quality of sleep. |
| From baseline to 4 weeks, and again to the end of treatment at 8 weeks. |
| Perceived Stress Scale (PSS) | Perceived Stress Scale (PSS) is a 10-item scale that will measure the perception of stress. It will be used to assess the levels of stress among subjects during the trial and quantity its levels. | From baseline to 4 weeks, and again to the end of treatment at 8 weeks. |
| Montgomery Asberg Depression Rating Scale (MADRS) | Montgomery Asberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale to measure depression. It will be used to monitor subjects for changes in severity of depressive symptoms during the trial. | From baseline to 4 weeks, and again to the end of treatment at 8 weeks. |
| Hair Cortisol | A biomarker used to assess long-term cortisol exposure. | From baseline to 4 weeks, and again to the end of treatment at 8 weeks. |
| C-reactive protein (CRP) | C-reactive protein (CRP) is an acute-phase protein produced by the liver in response to inflammation. It serves as a biomarker of systemic inflammation, with higher levels indicating infection, tissue injury, or chronic inflammatory conditions such as cardiovascular or metabolic disease. | From baseline to 4 weeks, and again to the end of treatment at 8 weeks. |
| Interleukin-6 (IL-6) | Interleukin-6 (IL-6) is a cytokine that plays a key role in the body's immune response and inflammation, used as a biomarker for systemic inflammation. | From baseline to 4 weeks, and again to the end of treatment at 8 weeks. |
| Tumor necrosis factor-alpha (TNF-α) | Tumor necrosis factor-alpha (TNF-α) is a pro-inflammatory cytokine produced primarily by macrophages and other immune cells, used as a biomarker for systemic inflammation. | From baseline to 4 weeks, and again to the end of treatment at 8 weeks. |
| Total sleep time (TST) | Total sleep time (TST) will be calculated using wrist-based actigraphy. TST will include the amount of time spent asleep while in bed, obtained in minutes. | Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks. |
| Sleep onset latency (SOL) | Sleep onset latency (SOL) will be obtained using wrist-based actigraphy. SOL measures the amount of time it takes to fall asleep after getting into bed, measured in minutes. | Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks. |
| Sleep efficiency (SE) | Sleep efficiency (SE) will be measured using a wrist-based actigraphy. SE measures the percent of time in sleep that is actually spent asleep, obtained in minutes. | Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks. |
| Wake after sleep onset (WASO) | Wake after sleep onset (WASO) will be obtained using a wrist-based actigraphy. WASO represents the amount of time awake after initially falling asleep, measured in minutes. | Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks. |
| Number of wake bouts | Number of wake bouts will be measured using wrist-based actigraphy. Number of wake up bouts represents the number of times woken up during the night. | Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks. |
| Sedentary activity (SA) | Sedentary activity (SA) will be measured using wrist-based actigraphy, using wrist cut-points. Counts per minute will be used to quantify time spent in sedentary and non-sedentary styles in older adults | Obtained at screening, from baseline to 4 weeks, and again to the end of treatment at 8 weeks. |
| Institute on Aging Unversity of Florida | Gainesville | Florida | 32610 | United States |
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| D001523 |
| Mental Disorders |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |