Kaempferol Absorption and Pharmacokinetics Evaluation (K.A.P.E.)
University of Pittsburgh
Summary
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. Participants 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. The 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.
Description
This multi-site interventional study evaluates the pharmacokinetics and biological absorption of Kaempferol (KMP) in a U.S. population and is designed to generate human data to inform regulatory and translational planning for Kaempferol. Kaempferol is a diet-derived flavonoid present in plant-based foods and dietary supplements. Existing evidence supporting biological activity has largely been derived from in vitro and animal studies, with limited human clinical data describing absorption, metabolism, and excretion. Preliminary nonclinical data support measurable biological activity following…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Adults aged 18 to 70 years * Healthy volunteers as determined by medical history and screening assessment * Ability to understand the study procedures and provide informed consent * Willingness and ability to comply with all study procedures, including dietary restrictions, clinic visits, blood draws, urine collection, and follow-up assessments * Willingness to abstain from restricted foods, beverages, and supplements as specified in the study protocol during the study period Exclusion Criteria: * Known allergy or hypersensitivity to Kaempferol or related flavonoids * P…
Interventions
- Dietary SupplementKaempferol
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.
Locations (3)
- Weill Cornell MedicineNew York, New York
- University of North Carolina at Chapel HillChapel Hill, North Carolina
- University of PittsburghPittsburgh, Pennsylvania