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.
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
Known allergy or hypersensitivity to Kaempferol or related flavonoids
Pregnancy or breastfeeding
Active or chronic infections
Cancer
Single group
Kaempferol
Dietary supplementKaempferol (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.
Maximum plasma concentration (Cmax) of Kaempferol
The maximum observed plasma concentration of Kaempferol following oral administration, calculated from serial plasma samples collected at predefined time points.
Time to maximum plasma concentration (Tmax) of Kaempferol
The time elapsed from oral administration of Kaempferol to the occurrence of the maximum observed plasma concentration (Cmax), determined from serial plasma sampling.
Area under the plasma concentration-time curve (AUC) of Kaempferol
The area under the plasma concentration-time curve of Kaempferol, calculated using noncompartmental methods to quantify overall systemic exposure following oral administration.
Plasma elimination half-life (t½) of Kaempferol
The terminal elimination half-life of Kaempferol in plasma, estimated from the terminal phase of the concentration-time curve following oral administration.
Differential gene expression associated with Kaempferol exposure
Changes in gene expression will be quantified using RNA sequencing of peripheral blood samples. Differential expression will be reported as log2 fold change with associated statistical significance (e.g., adjusted p-values or false discovery rate) comparing post-dose time points to baseline.
Changes in circulating microRNA (miRNA) expression following Kaempferol administration
Circulating miRNA expression levels will be quantified using miRNA sequencing. Outcomes will be reported as normalized expression values and log2 fold changes relative to baseline, with statistical significance assessed across post-dose time points.
Changes in plasma metabolite profiles associated with Kaempferol exposure
Plasma metabolite concentrations will be measured using mass spectrometry-based metabolomics. Outcomes will be reported as relative or absolute metabolite abundances, pathway-level enrichment scores, and fold changes comparing post-dose samples to baseline.
Changes in lipidomic profiles following Kaempferol administration
Lipid species concentrations will be quantified using lipidomics platforms. Results will be reported as normalized lipid abundances, fold changes from baseline, and pathway-level alterations associated with lipid metabolism.
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University of Pittsburgh
Lead sponsor
Otsuka Pharmaceutical Co., Ltd.
Collaborator
