Kaempferol Absorption and Pharmacokinetics Evaluation

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.

Conditions

• No Disease
• Mitochondria Health
• Longevity
• Pharmacokinetics and Biological Absorption of Kaempferol in Healthy Adult
• Healthy Volunteers

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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.

  collaborator INDUSTRY

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Afshin Beheshti, PhD · University of Pittsburgh

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-12-09

Primary Completion

2026-12-09

Completion

2027-12-22

Countries

• United States

Study Locations