[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617729":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":101,"collaborators":104,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":116,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":20,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":133,"overallStatus":82,"whyStopped":20,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Kaempferol Intervention Arm","EXPERIMENTAL","Participants in this single-arm intervention receive oral Kaempferol (KMP) administered as capsules once daily for 8 days as part of a controlled dietary regimen. All participants undergo standardized pharmacokinetic blood and urine sampling at predefined time points, along with safety monitoring and comprehensive multi-omics analyses to assess absorption, metabolism, tolerability, and biological responses to Kaempferol.",[13],"Dietary Supplement: Kaempferol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","Kaempferol","Kaempferol (KMP) is administered orally as encapsulated doses once daily for 8 consecutive days in healthy adult participants under controlled dietary conditions. This intervention is designed specifically for intensive pharmacokinetic characterization and biological absorption assessment, incorporating high-frequency serial blood and urine sampling across multiple time points. In contrast to typical dietary supplement studies, this intervention integrates comprehensive multi-omics profiling (including transcriptomics, miRNA-seq, metabolomics, lipidomics, proteomics, and genomic analyses) to evaluate mechanistic and functional biological responses to Kaempferol exposure. Safety and tolerability are monitored throughout the intervention period.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Afshin Beheshti, PhD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","6173082540","beheshti@pitt.edu",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Arabella Johnson","+13155659660","AAJ28@pitt.edu",[35,61,81],{"facility":36,"status":37,"city":38,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Weill Cornell Medicine","NOT_YET_RECRUITING","New York","10065","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-74.00597,40.71427,{"lat":46,"lon":45},[49,53,57,59],{"name":50,"role":27,"phone":51,"phoneExt":20,"email":52},"Robert E Schwartz, MD PhD","7634386040","res2025@med.cornell.edu",{"name":54,"role":27,"phone":55,"phoneExt":20,"email":56},"Christopher E Mason, PhD","2036681448","chm2042@med.cornell.edu",{"name":58,"role":24,"phone":20,"phoneExt":20,"email":20},"Robert Schwartz, MD PhD",{"name":54,"role":60,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"facility":62,"status":37,"city":63,"state":64,"zip":65,"country":40,"countryCode":41,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599",{"type":43,"coordinates":67},[68,69],-79.05584,35.9132,{"lat":69,"lon":68},[72,76,80],{"name":73,"role":27,"phone":74,"phoneExt":20,"email":75},"Jonathan C Schisler, PhD","9192441141","schisler@unc.edu",{"name":77,"role":27,"phone":78,"phoneExt":20,"email":79},"Victoria A Scott, MHS","9199660864","kapestudy@med.unc.edu",{"name":73,"role":24,"phone":20,"phoneExt":20,"email":20},{"facility":5,"status":82,"city":83,"state":84,"zip":85,"country":40,"countryCode":41,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"RECRUITING","Pittsburgh","Pennsylvania","15219",{"type":43,"coordinates":87},[88,89],-79.99589,40.44062,{"lat":89,"lon":88},[92,96,98,99],{"name":93,"role":27,"phone":94,"phoneExt":20,"email":95},"Stephanie K Montgomery, MBA MPH","6102094365","SKM66@pitt.edu",{"name":97,"role":27,"phone":32,"phoneExt":20,"email":33},"Arabella J Johnson",{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"name":100,"role":60,"phone":20,"phoneExt":20,"email":20},"Matthew D Neal, MD FACS",{"type":24,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Afshin Beheshti","Professor\u002FDirector",[105],{"name":106,"class":107},"Otsuka Pharmaceutical Co., Ltd.","INDUSTRY","100617729","kaempferol-absorption-and-pharmacokinetics-evaluation-100617729",false,"NCT07322406","Kaempferol Absorption and Pharmacokinetics Evaluation","Kaempferol Absorption and Pharmacokinetics Evaluation (K.A.P.E.)","KAPE","Inclusion Criteria:\n\nAdults aged 18 to 70 years\n\n* Healthy volunteers as determined by medical history and screening assessment\n* Ability to understand the study procedures and provide informed consent\n* Willingness and ability to comply with all study procedures, including dietary restrictions, clinic visits, blood draws, urine collection, and follow-up assessments\n* Willingness to abstain from restricted foods, beverages, and supplements as specified in the study protocol during the study period\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to Kaempferol or related flavonoids\n* Pregnancy or breastfeeding\n* Presence of significant acute or chronic medical conditions that could increase risk or interfere with study outcomes, including but not limited to:\n* Active or chronic infections\n* Cancer\n* Cardiovascular disease\n* Neurological or neurodegenerative disorders\n* Metabolic or systemic inflammatory conditions\n* Use of prescription medications or supplements known to interfere with Kaempferol metabolism or pharmacokinetic assessment\n* Blood donation within 8 weeks prior to study enrollment\n* Participation in another interventional clinical study within a timeframe that could interfere with study results or participant safety\n* Any condition or circumstance that, in the judgment of the study investigator, would make participation unsafe or compromise data integrity",true,"ALL","18 Years","70 Years",{"count":121,"type":122},120,"ESTIMATED","INTERVENTIONAL",[125],"NA","This study is a multi-site clinical trial designed to evaluate how the body absorbs and processes Kaempferol, a naturally occurring compound found in many plant-based foods. The primary purpose of the study is to measure the pharmacokinetics and biological absorption of Kaempferol in healthy adults.\n\nParticipants will receive Kaempferol and undergo scheduled blood and urine collections over a short study period. These samples will be used to measure Kaempferol levels in the body and to assess safety and tolerability. In addition, selected biological samples will be analyzed to explore molecular changes associated with Kaempferol exposure using advanced laboratory methods.\n\nThe study will be conducted at multiple research centers in the United States using a standardized protocol to ensure consistency across sites. The information collected will help improve understanding of how Kaempferol is absorbed and metabolized in humans and will support future research and regulatory evaluation.",[128,129,130,131,132],"No Disease","Mitochondria Health","Longevity","Pharmacokinetics and Biological Absorption of Kaempferol in Healthy Adult","Healthy Volunteers",[134,17,135,136,137,138,139,140,141],"Mitochondria","KMP","Pharmacokinetics","Bioavailability","Absorption","Dietary supplement","Healthy volunteers","Multi-omics","2026-03-19",{"date":144,"type":145},"2026-03-23","ACTUAL",{"date":147,"type":145},"2025-12-09",{"date":149,"type":122},"2027-12-22",{"name":5,"class":6},3]