Kaempferol Absorption and Pharmacokinetics Evaluation

NCT07322406 | Recruiting DMC

• 1 other identifier: STUDY25100114
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Mitochondria; Kaempferol; KMP; Pharmacokinetics; Bioavailability; Absorption; Dietary supplement; Healthy volunteers; Multi-omics

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Differential gene expression 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)

• Changes in circulating microRNA (miRNA) expression following Kaempferol administration

  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

  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

  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

  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)

Study Arms (1)

Kaempferol Intervention Arm

EXPERIMENTAL

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

Interventions

Kaempferol 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.

Kaempferol Intervention Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (3)

Weill Cornell Medicine

New York, New York, 10065, United States

NOT YET RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

NOT YET RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

MeSH Terms

Interventions

kaempferol

Study Officials

• Afshin Beheshti, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Afshin Beheshti, PhD

CONTACT

6173082540; beheshti@pitt.edu

Arabella Johnson

CONTACT

+13155659660; AAJ28@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label, single-arm pharmacokinetic and safety study in healthy volunteers. All participants and study personnel are aware of the intervention being administered.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Director

Model Details: * All enrolled participants receive the same intervention (oral Kaempferol administered as capsules over 8 days). * There is no placebo group, no comparator, and no randomization. * Outcomes (PK, safety, and multi-omics endpoints) are assessed within the same group over time using pre- and post-intervention measurements. * The primary goal is pharmacokinetic characterization and biological absorption, not comparative efficacy.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 7, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): December 9, 2026
• Study Completion (Estimated): December 22, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)