NCT07322406 · University of Pittsburgh
Kaempferol Absorption and Pharmacokinetics Evaluation
(KAPE)
What this study is about
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 how the drug moves through the body and biological absorption of Kaempferol in healthy adults.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
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 measures
Maximum plasma concentration (Cmax) of Kaempferol
Time frame: From dosing on Day 1 through 24 hours after the final dose (Day 8)
The maximum observed plasma concentration of Kaempferol following oral administration, calculated from serial plasma samples collected at predefined time points.
Time to maximum plasma concentration (Tmax) of Kaempferol
Time frame: From dosing on Day 1 through 24 hours after the final dose (Day 8)
The time elapsed from oral administration of Kaempferol to the occurrence of the maximum observed plasma concentration (Cmax), determined from serial plasma sampling.
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)
The area under the plasma concentration-time curve of Kaempferol, calculated using noncompartmental methods to quantify overall systemic exposure following oral administration.
Plasma elimination half-life (t½) of Kaempferol
Time frame: From dosing on Day 1 through 24 hours after the final dose (Day 8)
The terminal elimination half-life of Kaempferol in plasma, estimated from the terminal phase of the concentration-time curve following oral administration.
Apparent clearance of Kaempferol
Time frame: From dosing on Day 1 through 24 hours after the final dose (Day 8)
The apparent systemic clearance of Kaempferol following oral administration, calculated using standard pharmacokinetic methods based on plasma concentration data.
Urinary excretion of Kaempferol and metabolites
Time frame: From dosing on Day 1 through 24 hours after the final dose (Day 8)
The cumulative amount of Kaempferol and its metabolites excreted in urine, determined from timed urine collections following oral administration.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- New York, New York
- Chapel Hill, North Carolina
- Pittsburgh, Pennsylvania
Collaborators
Otsuka Pharmaceutical Co., Ltd.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 23, 2026 · Source of record for eligibility and locations