[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609792":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":67,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":11,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":11,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":97,"overallStatus":101,"whyStopped":11,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of Florida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AB-free Kava","EXPERIMENTAL",null,[13],"Drug: AB-free kava",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Other: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","AB-free kava","AB-free kava (75mg kavalactones per capsule, for a total of 225 mg\u002Fday)",[9],{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":11},"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.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Chengguo Xing, PhD","CONTACT","(352) 294-8511","chengguoxing@ufl.edu",[35,51],{"facility":36,"status":11,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Institute on Aging University of Florida","Gainesville","Florida","32610","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-82.32483,29.65163,{"lat":46,"lon":45},[49],{"name":50,"role":31,"phone":11,"phoneExt":11,"email":11},"Stephen D. Anton, Ph.D.",{"facility":52,"status":11,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":53,"geoPoint":55,"contacts":56},"Institute on Aging Unversity of Florida",{"type":43,"coordinates":54},[45,46],{"lat":46,"lon":45},[57,61,65],{"name":58,"role":31,"phone":59,"phoneExt":11,"email":60},"Christian W. McLaren, M.S.","863-263-7867","mclaren@ufl.edu",{"name":62,"role":31,"phone":63,"phoneExt":11,"email":64},"Nevena Stanojevic, B.S.","(352) 294-5824","nevenastanojevic@ufl.edu",{"name":50,"role":66,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":68,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[70],{"name":71,"class":72},"National Institute on Aging (NIA)","NIH","100609792","early-phase-1-kava-aging-and-mobility-study-100609792",false,"NCT07219186","Kava Aging and Mobility Study","Impacts of AB-free Kava on Mitigating Mobility Loss With Aging: A Pilot Study","Inclusion Criteria:\n\n* Age \\> 70 years\n* 8 ≤ Insomnia severity index (ISI) ≤21\n* 4m walking speed \\\u003C1 m\u002Fsec and \\>0.44 m\u002Fsec\n* Mild to moderate physical impairment (Short Physical Performance Battery score \\\u003C 10)\n* Sedentary lifestyle (\\\u003C 150 min per week of moderate intensity physical activity) verified by CHAMPS questionnaire\n* Willingness and ability to give informed consent\n* Willingness to be randomized to the intervention groups\n* Availability for participation through duration of study Exclusion Criteria (General)\n* Failure to provide informed consent\n* 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)\n* Abnormal laboratory markers (e.g., renal or liver abnormalities, elevated potassium levels, or hemoglobin and hematocrit below the lower limit of normal)\n* Residence in a Skilled Nursing Facility (SNF); residence in an Assisted Living Facility (ALF) or independent housing is allowed\n* Self-reported inability to walk one block\n* Significant cognitive impairment, defined as a known diagnosis of dementia or a Mini-Mental Status Exam score \\\u003C 24\n* Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active inflammatory disease)\n* Terminal illness with life expectancy less than 12 months, as determined by a physician\n* 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\n* Severe pulmonary disease, pneumonitis or interstitial lung disease\n* Other significant co-morbid disease (e.g. renal failure on hemodialysis) or severe psychiatric disorder (e.g. bipolar, schizophrenia)\n* Current use of antidepressant medications, antipsychotic agents, monoamine oxidase inhibitors, anticholinesterase inhibitors (i.e., Aricept)\n* Refuses to reduce alcohol use to 3 or fewer alcoholic drinks per week during the study\n* Planning to permanently leave the area in the next year\n* Blood pressure readings \\>180\u002F100 at screening\n* Participating in another clinical trial or has received an investigational product within 30 days prior to screening\u002Fenrollment.\n\nExclusion Criteria (AB-free kava-related)\n\n* Regular use of any medications that contain acetaminophen\n* Current use of any forms of kava and not willing to stop for a 2-week washout period - dietary supplements or beverages\n* Current use of antidepressant medications and antipsychotic agents (including monoamine oxidase inhibitors), or anticholinesterase inhibitors (i.e., Aricept)\n* Diagnosed with liver dysfunction or with previous liver diseases during the past five years\n* Levels of ALT, AST, ALP or total bilirubin over 3xlimit of normal (ULN) range at prescreen\n\nTemporary Exclusion Criteria\n\n* Acute infection (urinary, respiratory, other) or hospitalization within 1 month\n* Myocardial infarction, CABG, or valve replacement within past 6 months\n* Pulmonary embolism or deep venous thrombosis within past 6 months\n* Stroke, hip fracture, hip or knee replacement, or spinal surgery within past 4 months\n* Receiving physical therapy for gait, balance, or other lower extremity training","ALL","70 Years",{"count":83,"type":84},40,"ESTIMATED","INTERVENTIONAL",[87],"EARLY_PHASE1","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:\n\n* Does AB-free kava improve physical function and\u002For mobility?\n* 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.",[90,91,92,93,94,95,96],"Old Adults","Sleep Quality","Kava","Mobility Impairment","Physical Activity and Stress","Physical Impairment","Sedentary Lifestyle in Patients Over 70",[9,98,99,100],"Old adults","Sleep Difficulties","Mobility Limitations","NOT_YET_RECRUITING","2026-01-30",{"date":104,"type":105},"2026-02-02","ACTUAL",{"date":107,"type":84},"2026-04",{"date":109,"type":84},"2027-05",{"name":5,"class":6},2]