Kaempferol for Healthy Subjects
(KAPE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how the body absorbs and processes Kaempferol, a natural compound in many plant foods. Researchers aim to assess Kaempferol's absorption, safety, and molecular effects on the body. Participants will take Kaempferol capsules and provide blood and urine samples to measure these effects. Healthy adults who can adhere to specific dietary rules and do not have certain medical conditions may qualify for this trial. As an unphased trial, this study offers a unique opportunity to contribute to foundational research on Kaempferol's health benefits.
Will I have to stop taking my current medications?
The trial requires that you do not use prescription medications or supplements known to interfere with Kaempferol metabolism. It's best to discuss your current medications with the study team to see if they are allowed.
What prior data suggests that Kaempferol is safe for humans?
Research has shown that Kaempferol is generally safe for people. One study found that healthy adults took 50 mg of Kaempferol daily for four weeks without any safety issues, suggesting the compound is well-tolerated over a longer period.
Safety information notes that Kaempferol can cause eye irritation, but it is unlikely to cause allergic reactions when inhaled or applied to the skin.
Overall, current evidence indicates that Kaempferol is safe for use in healthy individuals. However, as with any treatment, monitoring for unexpected side effects is important.12345Why are researchers excited about this trial?
Unlike standard treatments that often involve synthetic drugs, Kaempferol is a natural compound found in various plants and foods. Researchers are excited about Kaempferol because it offers a new approach by potentially providing health benefits through its antioxidant and anti-inflammatory properties. Additionally, Kaempferol is administered orally as a capsule, which can be more convenient and easier for patients to take compared to other forms of treatment. This natural and accessible option could lead to a more holistic way to support health without the side effects associated with many synthetic drugs.
What evidence suggests that Kaempferol is effectively absorbed and metabolized in healthy adults?
Research has shown that kaempferol, a natural compound found in plants, may offer health benefits. One study discovered that a single dose of kaempferol reduced muscle damage and eased strain on the heart and lungs during exercise. Additionally, it has been linked to better sleep and could enhance overall quality of life over time. The current trial involves a single-arm intervention where participants receive oral kaempferol to examine its absorption and utilization in the body. These findings suggest it might positively affect health.36789
Who Is on the Research Team?
Afshin Beheshti, PhD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
Healthy adults aged 18 to 70 who understand the study and agree to its procedures, including dietary restrictions, clinic visits, blood draws, urine collection, and follow-ups. Participants must avoid certain foods, drinks, and supplements as outlined in the protocol.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral Kaempferol administered as capsules once daily for 8 days with scheduled blood and urine collections
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and laboratory evaluations
What Are the Treatments Tested in This Trial?
Interventions
- Kaempferol
Trial Overview
The trial is studying how Kaempferol—a compound found in plants—is absorbed and processed by healthy adults. It involves taking Kaempferol followed by regular blood and urine tests to measure its levels in the body.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Industry Sponsor
Tarek Rabah
Otsuka Pharmaceutical Co., Ltd.
Chief Executive Officer since 2022
BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University
John Kraus
Otsuka Pharmaceutical Co., Ltd.
Chief Medical Officer since 2021
MD and PhD in Neurobiology from Duke University
Citations
Kaempferol Absorption and Pharmacokinetics Evaluation
This study is a multi-site clinical trial designed to evaluate how the body absorbs and processes Kaempferol, a naturally occurring compound ...
A Double‐Blind, Randomized, Placebo‐Controlled Trial - PMC
A single oral dose of kaempferol reduced the cardiopulmonary burden and muscle damage in individuals participating in 400‐m runs.
3.
withpower.com
withpower.com/trial/phase-pharmacokinetics-and-biological-absorption-of-kaempferol-in-healthy-adult-11-2025-7cfcbKaempferol for Healthy Subjects (KAPE Trial)
The primary purpose of the study is to measure the pharmacokinetics and biological absorption of Kaempferol in healthy adults.
Kaempferol: Paving the path for advanced treatments in ...
Kaempferol, a flavonoid found in several plants, has emerged as a promising candidate for ameliorating ARDs.
Effect of kaempferol ingestion on physical activity and ...
KMP leads to behavioral changes that subsequently improve sleep quality and potentially improve long-term quality of life.
Safety Data Sheet
Safety, health and environmental regulations/legislation specific for the substance or mixture. No further relevant information available. · ...
A randomized, placebo‐controlled trial evaluating the ...
The study results revealed that the consumption of 50-mg KMP aglycone daily for 4 weeks is safe in healthy adults.
Kaempferol - Safety Data Sheet
Causes serious eye irritation. Respiratory or skin sensitisation. Shall not be classified as a respiratory or skin sensitiser. Safety data sheet.
Safety evaluation of kaempferol glycosides-rich ...
The aim of the research was to evaluate the single dose acute, 14-day repeated oral toxicity, and genotoxicity of standardized roasted GL extract (rGL)
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