Kaempferol absorption and pharmacokinetics in healthy adults
Kaempferol Absorption and Pharmacokinetics Evaluation (K.A.P.E.)
This trial will test how oral kaempferol is absorbed and processed in healthy adults by measuring levels in blood and urine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 3 sites (New York, New York and 2 other locations) |
| Trial ID | NCT07322406 on ClinicalTrials.gov |
What this trial studies
This multi-site interventional study gives a controlled oral dose of kaempferol to healthy adult volunteers and collects serial blood and urine samples over a short period. Samples are processed using harmonized procedures at each site and analyzed centrally to define pharmacokinetic parameters and bioavailability. Selected biospecimens will undergo molecular profiling to explore changes linked to kaempferol exposure, including markers related to metabolism and mitochondrial function. The overall goal is to generate standardized human data to inform dosing, safety, and future translational or regulatory planning.
Who should consider this trial
Good fit: Healthy adults aged 18 to 70 who can follow dietary restrictions, attend clinic visits, and tolerate blood and urine collections.
Not a fit: People with significant acute or chronic medical conditions, pregnant or breastfeeding individuals, those taking interfering medications or supplements, or anyone with known flavonoid allergy are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could clarify how kaempferol is absorbed and metabolized and provide safety and dosing information to guide future clinical use or supplement recommendations.
How similar studies have performed: Small prior human studies suggest kaempferol is generally tolerable, but comprehensive pharmacokinetic characterization and integrated molecular profiling in a standardized multi-site setting remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York and 2 other locations
- Weill Cornell Medicine — New York, New York, United States (Not_yet_recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Not_yet_recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Afshin Beheshti, PhD — University of Pittsburgh
- Study coordinator: Afshin Beheshti, PhD
- Email: beheshti@pitt.edu
- Phone: 6173082540
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.