Kaempferol Absorption and Pharmacokinetics Evaluation

Part of paid clinical trials in New York, New York.

Sponsor
University of Pittsburgh
Study ID
NCT07322406
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Dec 9, 2025
Status verified
Mar 2026
Primary completion
Dec 9, 2026
Completion
Dec 22, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

Maximum plasma concentration (Cmax) of Kaempferol [ Time Frame: From dosing on Day 1 through 24 hours after the final dose (Day 8) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065
Robert E Schwartz, MD PhD
7634386040
Christopher E Mason, PhD
2036681448
Robert Schwartz, MD PhD (PRINCIPAL_INVESTIGATOR)
Christopher E Mason, PhD (SUB_INVESTIGATOR)
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Jonathan C Schisler, PhD
9192441141
Victoria A Scott, MHS
9199660864
Jonathan C Schisler, PhD (PRINCIPAL_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15219
Stephanie K Montgomery, MBA MPH
6102094365
Arabella J Johnson
+13155659660
Afshin Beheshti, PhD (PRINCIPAL_INVESTIGATOR)
Matthew D Neal, MD FACS (SUB_INVESTIGATOR)

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