Kaempferol Absorption and Pharmacokinetics Evaluation (KAPE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers; No Disease; Longevity; Mitochondria Health; Pharmacokinetics and Biological Absorption of Kaempferol in Healthy Adult
• Intervention / Treatment: Dietary supplement: Kaempferol

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Afshin Beheshti, PhD; Phone Number: 6173082540; Email: beheshti@pitt.edu
• Study Contact Backup: Name: Arabella Johnson; Phone Number: +13155659660; Email: AAJ28@pitt.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Not yet recruiting
      • Weill Cornell Medicine
      • Contact: Robert E Schwartz, MD PhD; Phone Number: 7634386040; Email: res2025@med.cornell.edu
      • Contact: Christopher E Mason, PhD; Phone Number: 2036681448; Email: chm2042@med.cornell.edu
      • Principal Investigator: Robert Schwartz, MD PhD
      • Sub-Investigator: Christopher E Mason, PhD
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Not yet recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Jonathan C Schisler, PhD; Phone Number: 9192441141; Email: schisler@unc.edu
      • Principal Investigator: Jonathan C Schisler, PhD
      • Contact: Victoria A Scott, MHS; Phone Number: 9199660864; Email: kapestudy@med.unc.edu
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • Recruiting
      • University of Pittsburgh
      • Contact: Stephanie K Montgomery, MBA MPH; Phone Number: 6102094365; Email: SKM66@pitt.edu
      • Principal Investigator: Afshin Beheshti, PhD
      • Sub-Investigator: Matthew D Neal, MD FACS
      • Contact: Arabella J Johnson; Phone Number: +13155659660; Email: AAJ28@pitt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Kaempferol Intervention Arm; Participants in this single-arm intervention receive oral Kaempferol (KMP) administered as capsules once daily for 8 days as part of a controlled dietary regimen. All participants undergo standardized pharmacokinetic blood and urine sampling at predefined time points, along with safety monitoring and comprehensive multi-omics analyses to assess absorption, metabolism, tolerability, and biological responses to Kaempferol.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From dosing on Day 1 through 24 hours after the final dose (Day 8)
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.	From dosing on Day 1 through 24 hours after the final dose (Day 8)
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.	From dosing on Day 1 through 24 hours after the final dose (Day 8)
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.	From dosing on Day 1 through 24 hours after the final dose (Day 8)
Apparent clearance of Kaempferol	The apparent systemic clearance of Kaempferol following oral administration, calculated using standard pharmacokinetic methods based on plasma concentration data.	From dosing on Day 1 through 24 hours after the final dose (Day 8)
Urinary excretion of Kaempferol and metabolites	The cumulative amount of Kaempferol and its metabolites excreted in urine, determined from timed urine collections following oral administration.	From dosing on Day 1 through 24 hours after the final dose (Day 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 0 or pre-dose), Day 1 (pre-dose, 3 hours post-dose, 24 hours post-dose), Day 7 (pre-dose, 3 hours post-dose, 24 hours post-dose)
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.	Baseline (Day 0 or pre-dose), Day 1 (pre-dose, 3 hours post-dose, 24 hours post-dose), Day 7 (pre-dose, 3 hours post-dose, 24 hours post-dose)
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.	Baseline (Day 0 or pre-dose), Day 1 (pre-dose, 3 hours post-dose, 24 hours post-dose), Day 7 (pre-dose, 3 hours post-dose, 24 hours post-dose)
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.	Baseline (Day 0 or pre-dose), Day 1 (pre-dose, 3 hours post-dose, 24 hours post-dose), Day 7 (pre-dose, 3 hours post-dose, 24 hours post-dose)
Proteomic changes associated with Kaempferol exposure	Protein abundance will be quantified using mass spectrometry-based proteomics. Outcomes will be reported as normalized protein expression levels, fold changes relative to baseline, and enrichment of biological pathways associated with Kaempferol exposure.	Baseline (Day 0 or pre-dose), Day 1 (pre-dose, 3 hours post-dose, 24 hours post-dose), Day 7 (pre-dose, 3 hours post-dose, 24 hours post-dose)
Integrated multi-omics pathway perturbation associated with Kaempferol exposure	Integrated multi-omics analyses will be used to identify biological pathways altered following Kaempferol administration. Outcomes will be reported as pathway enrichment scores and network-level changes derived from combined transcriptomic, miRNA, metabolomic, lipidomic, and proteomic data.	Baseline (Day 0 or pre-dose) through Day 8 (24 hours after final dose)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Otsuka Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Afshin Beheshti, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2025
• Primary Completion (Estimated): December 9, 2026
• Study Completion (Estimated): December 22, 2027

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Healthy volunteers; Dietary supplement; Pharmacokinetics; Bioavailability; Mitochondria; Absorption; Multi-omics; Kaempferol; KMP
• Additional Relevant MeSH Terms: kaempferol
• Other Study ID Numbers: STUDY25100114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the study includes intensive pharmacokinetic and high-dimensional multi-omics data that could increase the risk of participant re-identification, even after de-identification. In addition, data sharing is subject to institutional policies, IRB restrictions, and data governance agreements that limit external distribution of individual-level data. Aggregate results and analyses will be disseminated through peer-reviewed publications and scientific presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No