Recruiting

Kaempferol

Sponsor:

University of Pittsburgh

Code:

NCT07322406

Conditions

No Disease

Mitochondria Health

Longevity

Pharmacokinetics and Biological Absorption of Kaempferol in Healthy Adult

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Kaempferol

Study Details

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

Study ID

NCT07322406

Start date

Dec 9, 2025

Status verified date

Mar, 2026

Completion date

Dec 22, 2027

Anticipated

Primary completion date

Dec 9, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

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.

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) ]
  • Time to maximum plasma concentration (Tmax) of Kaempferol [ Time Frame: From dosing on Day 1 through 24 hours after the final dose (Day 8) ]
  • Area under the plasma concentration-time curve (AUC) of Kaempferol [ Time Frame: From dosing on Day 1 through 24 hours after the final dose (Day 8) ]
  • Plasma elimination half-life (t½) of Kaempferol [ Time Frame: From dosing on Day 1 through 24 hours after the final dose (Day 8) ]
  • Apparent clearance of Kaempferol [ Time Frame: From dosing on Day 1 through 24 hours after the final dose (Day 8) ]
  • Urinary excretion of Kaempferol and metabolites [ Time Frame: From dosing on Day 1 through 24 hours after the final dose (Day 8) ]

Central Contacts and Locations

Central contacts

Afshin Beheshti, PhD

6173082540beheshti@pitt.edu

Arabella Johnson

+13155659660AAJ28@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Stephanie K Montgomery, MBA MPH

6102094365SKM66@pitt.edu

Arabella J Johnson

+13155659660AAJ28@pitt.edu

Principal Investigator:

Afshin Beheshti, PhD

More Information

Sponsor

University of Pittsburgh

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-03-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.