Kaempferol Absorption and Pharmacokinetics Evaluation

NCT ID: NCT07322406

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-09
• Study Completion Date: 2027-12-22

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Kaempferol

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Afshin Beheshti

Professor/Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Afshin Beheshti, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Weill Cornell Medicine

New York, New York, United States

Site Status: NOT_YET_RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: NOT_YET_RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Afshin Beheshti, PhD

Role: CONTACT

beheshti@pitt.edu

6173082540

David Maloney

Role: CONTACT

djm181@pitt.edu

7248750770

Facility Contacts

Robert E Schwartz, MD PhD

Role: primary

res2025@med.cornell.edu

7634386040

Christopher E Mason, PhD

Role: backup

chm2042@med.cornell.edu

2036681448

Jonathan C Schisler, PhD

Role: primary

schisler@unc.edu

9192441141

Victoria A Scott, MHS

Role: backup

kapestudy@med.unc.edu

9199660864

Stephanie K Montgomery, MBA MPH

Role: primary

SKM66@pitt.edu

6102094365

David J Maloney

Role: backup

djm181@pitt.edu

4123833765

Other Identifiers

STUDY25100114

Identifier Type: -

Identifier Source: org_study_id