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 oral administration, including changes consistent with altered metabolic and mitochondrial function. Prior small human studies suggest tolerability but have not provided comprehensive pharmacokinetic characterization or integrated molecular profiling. The current study is intended to address these gaps using standardized procedures across multiple U.S. clinical research sites.

Participants receive oral Kaempferol administered under controlled study conditions and complete a defined schedule of clinic visits with serial biospecimen collections. Biospecimens are processed using harmonized standard operating procedures at collection sites, with centralized laboratory analyses used to reduce variability and improve data quality. Research data are maintained using coded identifiers and stored in secure systems consistent with institutional data protection requirements.

Primary endpoint: The primary endpoint is characterization of the pharmacokinetic profile of Kaempferol, including assessment of absorption, distribution, metabolism, and excretion using serial Kaempferol and metabolite measurements in blood and urine across predefined time points.

Secondary endpoints: Secondary endpoints include exploratory assessment of biological responses associated with Kaempferol exposure using multi-omics profiling (including genomics, transcriptomics, miRNA profiling, metabolomics, lipidomics, and proteomics). Secondary analyses also include integration of molecular profiling results with participant self-reported medical history using computational approaches to explore patterns associated with Kaempferol exposure and inter-individual variability in biological response. Additional secondary endpoints include evaluation of mechanistic and functional biomarker changes associated with oxidative stress, inflammation, and metabolic health in relation to Kaempferol intake.

Safety endpoints: Safety is assessed throughout the study period. Primary safety endpoints include the incidence and characterization of adverse events (AEs) and serious adverse events (SAEs), and tolerability based on participant-reported symptoms and clinical assessments. Secondary safety endpoints include clinical laboratory evaluations, including complete blood count testing, to identify potential safety signals associated with Kaempferol administration.

All study activities are conducted under institutional review board oversight. Written informed consent is obtained prior to initiation of study procedures. A limited waiver of documentation of consent may be used only for specific preparatory dietary instructions when approved by the IRB and when required by scheduling and protocol timing. Participant confidentiality is maintained through coding of data, restricted access to identifiable information, and secure storage of study records.