Kaempferol Absorption and Pharmacokinetics Evaluation
Kaempferol Absorption and Pharmacokinetics Evaluation (K.A.P.E.)
University of Pittsburgh
120 participants
Dec 9, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria12
- Known allergy or hypersensitivity to Kaempferol or related flavonoids
- Pregnancy or breastfeeding
- Presence of significant acute or chronic medical conditions that could increase risk or interfere with study outcomes, including but not limited to:
- Active or chronic infections
- Cancer
- Cardiovascular disease
- Neurological or neurodegenerative disorders
- Metabolic or systemic inflammatory conditions
- Use of prescription medications or supplements known to interfere with Kaempferol metabolism or pharmacokinetic assessment
- Blood donation within 8 weeks prior to study enrollment
- Participation in another interventional clinical study within a timeframe that could interfere with study results or participant safety
- Any condition or circumstance that, in the judgment of the study investigator, would make participation unsafe or compromise data integrity
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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07322406