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_SUPPLEMENTKaempferol (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 ArmParticipants 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
- Afshin Beheshti, PhD6173082540
- Arabella Johnson+13155659660
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | Robert Schwartz, MD PhD (PRINCIPAL_INVESTIGATOR) Christopher E Mason, PhD (SUB_INVESTIGATOR) |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | Jonathan C Schisler, PhD (PRINCIPAL_INVESTIGATOR) |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15219 | Afshin Beheshti, PhD (PRINCIPAL_INVESTIGATOR) Matthew D Neal, MD FACS (SUB_INVESTIGATOR) |
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