No DiseaseKAPENCT07322406
Kaempferol Absorption and Pharmacokinetics Evaluation
A study testing Kaempferol in people with No Disease and Mitochondria Health, run by University of Pittsburgh at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- No Disease, Mitochondria Health, Longevity
- What is being tested?
- Kaempferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Dec 2025to 22 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Jonathan C Schisler, PhD, 9192441141, schisler@unc.edu
Victoria A Scott, MHS, 9199660864, kapestudy@med.unc.edu
- Not yet recruiting
Weill Cornell Medicine
New York, New York, 10065
Robert E Schwartz, MD PhD, 7634386040, res2025@med.cornell.edu
Christopher E Mason, PhD, 2036681448, chm2042@med.cornell.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
Stephanie K Montgomery, MBA MPH, 6102094365, SKM66@pitt.edu
Arabella J Johnson, +13155659660, AAJ28@pitt.edu
About this study
Official title: Kaempferol Absorption and Pharmacokinetics Evaluation (K.A.P.E.)
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.
Read the detailed description
This multi-site interventional study evaluates the pharmacokinetics and biological absorption of Kaempferol (KMP) in a U.S. population and is designed to generate human data to inform regulatory and translational planning for Kaempferol.
Kaempferol is a diet-derived flavonoid present in plant-based foods and dietary supplements. Existing evidence supporting biological activity has largely been derived from in vitro and animal studies, with limited human clinical data describing absorption, metabolism, and excretion. Preliminary nonclinical data support measurable biological activity following oral administration, including changes consistent with altered metabolic and mitochondrial function. Prior small human studies suggest tolerability but have not provided comprehensive pharmacokinetic characterization or integrated molecular profiling. The current study is intended to address these gaps using standardized procedures across multiple U.S. clinical research sites.
Participants receive oral Kaempferol administered under controlled study conditions and complete a defined schedule of clinic visits with serial biospecimen collections. Biospecimens are processed using harmonized standard operating procedures at collection sites, with centralized laboratory analyses used to reduce variability and improve data quality. Research data are maintained using coded identifiers and stored in secure systems consistent with institutional data protection requirements.
Primary endpoint: The primary endpoint is characterization of the pharmacokinetic profile of Kaempferol, including assessment of absorption, distribution, metabolism, and excretion using serial Kaempferol and metabolite measurements in blood and urine across predefined time points.
Secondary endpoints: Secondary endpoints include exploratory assessment of biological responses associated with Kaempferol exposure using multi-omics profiling (including genomics, transcriptomics, miRNA profiling, metabolomics, lipidomics, and proteomics). Secondary analyses also include integration of molecular profiling results with participant self-reported medical history using computational approaches to explore patterns associated with Kaempferol exposure and inter-individual variability in biological response. Additional secondary endpoints include evaluation of mechanistic and functional biomarker changes associated with oxidative stress, inflammation, and metabolic health in relation to Kaempferol intake.
Safety endpoints: Safety is assessed throughout the study period. Primary safety endpoints include the incidence and characterization of adverse events (AEs) and serious adverse events (SAEs), and tolerability based on participant-reported symptoms and clinical assessments. Secondary safety endpoints include clinical laboratory evaluations, including complete blood count testing, to identify potential safety signals associated with Kaempferol administration.
All study activities are conducted under institutional review board oversight. Written informed consent is obtained prior to initiation of study procedures. A limited waiver of documentation of consent may be used only for specific preparatory dietary instructions when approved by the IRB and when required by scheduling and protocol timing. Participant confidentiality is maintained through coding of data, restricted access to identifiable information, and secure storage of study records.
- Conditions
- No Disease, Mitochondria Health, Longevity, Pharmacokinetics and Biological Absorption of Kaempferol in Healthy Adult, Healthy Volunteers
- Being tested
- Kaempferol
- Keywords
- Mitochondria, Kaempferol, KMP, Pharmacokinetics, Bioavailability, Absorption, Dietary supplement, Healthy volunteers, Multi-omics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KaempferolDietary 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 group | Role | What they receive |
|---|---|---|
| Kaempferol Intervention Arm | Experimental | 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. Receives: Dietary Supplement: Kaempferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of Kaempferol
The maximum observed plasma concentration of Kaempferol following oral administration, calculated from serial plasma samples collected at predefined time points.
Measured: From dosing on Day 1 through 24 hours after the final dose (Day 8)
Time to maximum plasma concentration (Tmax) of Kaempferol
The time elapsed from oral administration of Kaempferol to the occurrence of the maximum observed plasma concentration (Cmax), determined from serial plasma sampling.
Measured: From dosing on Day 1 through 24 hours after the final dose (Day 8)
Area under the plasma concentration-time curve (AUC) of Kaempferol
The area under the plasma concentration-time curve of Kaempferol, calculated using noncompartmental methods to quantify overall systemic exposure following oral administration.
Measured: From dosing on Day 1 through 24 hours after the final dose (Day 8)
Plasma elimination half-life (t½) of Kaempferol
The terminal elimination half-life of Kaempferol in plasma, estimated from the terminal phase of the concentration-time curve following oral administration.
Measured: From dosing on Day 1 through 24 hours after the final dose (Day 8)
Apparent clearance of Kaempferol
The apparent systemic clearance of Kaempferol following oral administration, calculated using standard pharmacokinetic methods based on plasma concentration data.
Measured: From dosing on Day 1 through 24 hours after the final dose (Day 8)
Urinary excretion of Kaempferol and metabolites
The cumulative amount of Kaempferol and its metabolites excreted in urine, determined from timed urine collections following oral administration.
Measured: From dosing on Day 1 through 24 hours after the final dose (Day 8)
Secondary outcomes (6)
Differential gene expression associated with Kaempferol exposure
Changes in gene expression will be quantified using RNA sequencing of peripheral blood samples. Differential expression will be reported as log2 fold change with associated statistical significance (e.g., adjusted p-values or false discovery rate) comparing post-dose time points to baseline.
Measured: Baseline (Day 0 or pre-dose), Day 1 (pre-dose, 3 hours post-dose, 24 hours post-dose), Day 7 (pre-dose, 3 hours post-dose, 24 hours post-dose)
Changes in circulating microRNA (miRNA) expression following Kaempferol administration
Circulating miRNA expression levels will be quantified using miRNA sequencing. Outcomes will be reported as normalized expression values and log2 fold changes relative to baseline, with statistical significance assessed across post-dose time points.
Measured: Baseline (Day 0 or pre-dose), Day 1 (pre-dose, 3 hours post-dose, 24 hours post-dose), Day 7 (pre-dose, 3 hours post-dose, 24 hours post-dose)
Changes in plasma metabolite profiles associated with Kaempferol exposure
Plasma metabolite concentrations will be measured using mass spectrometry-based metabolomics. Outcomes will be reported as relative or absolute metabolite abundances, pathway-level enrichment scores, and fold changes comparing post-dose samples to baseline.
Measured: Baseline (Day 0 or pre-dose), Day 1 (pre-dose, 3 hours post-dose, 24 hours post-dose), Day 7 (pre-dose, 3 hours post-dose, 24 hours post-dose)
Changes in lipidomic profiles following Kaempferol administration
Lipid species concentrations will be quantified using lipidomics platforms. Results will be reported as normalized lipid abundances, fold changes from baseline, and pathway-level alterations associated with lipid metabolism.
Measured: Baseline (Day 0 or pre-dose), Day 1 (pre-dose, 3 hours post-dose, 24 hours post-dose), Day 7 (pre-dose, 3 hours post-dose, 24 hours post-dose)
Proteomic changes associated with Kaempferol exposure
Protein abundance will be quantified using mass spectrometry-based proteomics. Outcomes will be reported as normalized protein expression levels, fold changes relative to baseline, and enrichment of biological pathways associated with Kaempferol exposure.
Measured: Baseline (Day 0 or pre-dose), Day 1 (pre-dose, 3 hours post-dose, 24 hours post-dose), Day 7 (pre-dose, 3 hours post-dose, 24 hours post-dose)
Integrated multi-omics pathway perturbation associated with Kaempferol exposure
Integrated multi-omics analyses will be used to identify biological pathways altered following Kaempferol administration. Outcomes will be reported as pathway enrichment scores and network-level changes derived from combined transcriptomic, miRNA, metabolomic, lipidomic, and proteomic data.
Measured: Baseline (Day 0 or pre-dose) through Day 8 (24 hours after final dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start9 Dec 2025
- Primary completion9 Dec 2026 (estimated)
- Study completion22 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- * All enrolled participants receive the same intervention (oral Kaempferol administered as capsules over 8 days). * There is no placebo group, no comparator, and no randomization. * Outcomes (PK, safety, and multi-omics endpoints) are assessed within the same group over time using pre- and post-intervention measurements. * The primary goal is pharmacokinetic characterization and biological absorption, not comparative efficacy.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Afshin Beheshti, University of Pittsburgh
- Investigators
- Afshin Beheshti, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322406
- Sponsor's protocol ID
- STUDY25100114
- Acronym
- KAPE
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study includes intensive pharmacokinetic and high-dimensional multi-omics data that could increase the risk of participant re-identification, even after de-identification. In addition, data sharing is subject to institutional policies, IRB restrictions, and data governance agreements that limit external distribution of individual-level data. Aggregate results and analyses will be disseminated through peer-reviewed publications and scientific presentations.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kaempferol Absorption and Pharmacokinetics Evaluation (K.A.P.E.)
- ClinicalTrials.gov ID
- NCT07322406
- Acronym / sponsor ID
- KAPE / STUDY25100114
- Conditions
- No Disease, Mitochondria Health, Longevity, Pharmacokinetics and Biological Absorption of Kaempferol in Healthy Adult, Healthy Volunteers
- Keywords
- Mitochondria, Kaempferol, KMP, Pharmacokinetics, Bioavailability, Absorption, Dietary supplement, Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 9 Dec 2026 (estimated)
- Study completion
- 22 Dec 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multi-site interventional study evaluates the pharmacokinetics and biological absorption of Kaempferol (KMP) in a U.S. population and is designed to generate human data to inform regulatory and translational planning for Kaempferol.
Kaempferol is a diet-derived flavonoid present in plant-based foods and dietary supplements. Existing evidence supporting biological activity has largely been derived from in vitro and animal studies, with limited human clinical data describing absorption, metabolism, and excretion. Preliminary nonclinical data support measurable biological activity following oral administration, including changes consistent with altered metabolic and mitochondrial function. Prior small human studies suggest tolerability but have not provided comprehensive pharmacokinetic characterization or integrated molecular profiling. The current study is intended to address these gaps using standardized procedures across multiple U.S. clinical research sites.
Participants receive oral Kaempferol administered under controlled study conditions and complete a defined schedule of clinic visits with serial biospecimen collections. Biospecimens are processed using harmonized standard operating procedures at collection sites, with centralized laboratory analyses used to reduce variability and improve data quality. Research data are maintained using coded identifiers and stored in secure systems consistent with institutional data protection requirements.
Primary endpoint: The primary endpoint is characterization of the pharmacokinetic profile of Kaempferol, including assessment of absorption, distribution, metabolism, and excretion using serial Kaempferol and metabolite measurements in blood and urine across predefined time points.
Secondary endpoints: Secondary endpoints include exploratory assessment of biological responses associated with Kaempferol exposure using multi-omics profiling (including genomics, transcriptomics, miRNA profiling, metabolomics, lipidomics, and proteomics). Secondary analyses also include integration of molecular profiling results with participant self-reported medical history using computational approaches to explore patterns associated with Kaempferol exposure and inter-individual variability in biological response. Additional secondary endpoints include evaluation of mechanistic and functional biomarker changes associated with oxidative stress, inflammation, and metabolic health in relation to Kaempferol intake.
Safety endpoints: Safety is assessed throughout the study period. Primary safety endpoints include the incidence and characterization of adverse events (AEs) and serious adverse events (SAEs), and tolerability based on participant-reported symptoms and clinical assessments. Secondary safety endpoints include clinical laboratory evaluations, including complete blood count testing, to identify potential safety signals associated with Kaempferol administration.
All study activities are conducted under institutional review board oversight. Written informed consent is obtained prior to initiation of study procedures. A limited waiver of documentation of consent may be used only for specific preparatory dietary instructions when approved by the IRB and when required by scheduling and protocol timing. Participant confidentiality is maintained through coding of data, restricted access to identifiable information, and secure storage of study records.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * All enrolled participants receive the same intervention (oral Kaempferol administered as capsules over 8 days). * There is no placebo group, no comparator, and no randomization. * Outcomes (PK, safety, and multi-omics endpoints) are assessed within the same group over time using pre- and post-intervention measurements. * The primary goal is pharmacokinetic characterization and biological absorption, not comparative efficacy.
| Arm | Type | Receives |
|---|---|---|
| Kaempferol Intervention Arm | Experimental | Dietary Supplement: KaempferolParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KaempferolKaempferol (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. | Dietary supplement | Kaempferol Intervention Arm |
Primary outcome
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.
6 secondary outcomes
Differential gene expression associated with Kaempferol exposure
Time frame: Baseline (Day 0 or pre-dose), Day 1 (pre-dose, 3 hours post-dose, 24 hours post-dose), Day 7 (pre-dose, 3 hours post-dose, 24 hours post-dose)
Changes in circulating microRNA (miRNA) expression following Kaempferol administration
Time frame: Baseline (Day 0 or pre-dose), Day 1 (pre-dose, 3 hours post-dose, 24 hours post-dose), Day 7 (pre-dose, 3 hours post-dose, 24 hours post-dose)
Changes in plasma metabolite profiles associated with Kaempferol exposure
Time frame: Baseline (Day 0 or pre-dose), Day 1 (pre-dose, 3 hours post-dose, 24 hours post-dose), Day 7 (pre-dose, 3 hours post-dose, 24 hours post-dose)
Changes in lipidomic profiles following Kaempferol administration
Time frame: Baseline (Day 0 or pre-dose), Day 1 (pre-dose, 3 hours post-dose, 24 hours post-dose), Day 7 (pre-dose, 3 hours post-dose, 24 hours post-dose)
Proteomic changes associated with Kaempferol exposure
Time frame: Baseline (Day 0 or pre-dose), Day 1 (pre-dose, 3 hours post-dose, 24 hours post-dose), Day 7 (pre-dose, 3 hours post-dose, 24 hours post-dose)
Integrated multi-omics pathway perturbation associated with Kaempferol exposure
Time frame: Baseline (Day 0 or pre-dose) through Day 8 (24 hours after final dose)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study includes intensive pharmacokinetic and high-dimensional multi-omics data that could increase the risk of participant re-identification, even after de-identification. In addition, data sharing is subject to institutional policies, IRB restrictions, and data governance agreements that limit external distribution of individual-level data. Aggregate results and analyses will be disseminated through peer-reviewed publications and scientific presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Afshin Beheshti, PhD principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kaempferol in people with No Disease and Mitochondria Health, run by University of Pittsburgh at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Afshin Beheshti, PhD (6173082540, beheshti@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.