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RECRUITING
NCT07322406
NA

Kaempferol Absorption and Pharmacokinetics Evaluation

Sponsor: University of Pittsburgh

View on ClinicalTrials.gov

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.

Official title: Kaempferol Absorption and Pharmacokinetics Evaluation (K.A.P.E.)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-12-09

Completion Date

2027-12-22

Last Updated

2026-03-23

Healthy Volunteers

Yes

Interventions

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.

Locations (3)

Weill Cornell Medicine

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States