Actively Recruiting
Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity
Led by Ove Andersen · Updated on 2026-03-27
60
Participants Needed
1
Research Sites
427 weeks
Total Duration
On this page
Sponsors
O
Ove Andersen
Lead Sponsor
U
University of Southern Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
The accumulation of senescent cells with age is a central mechanism that contributes to the development of chronic diseases, primarily by driving systemic chronic inflammation. Senolytic compounds such as fisetin can selectively target senescent cells for elimination and reduce multiple age-related pathologies in animal models. We will conduct a clinical trial in healthy volunteers and older patients with multiple chronic diseases. The participants will receive fisetin or placebo for two days, after which they will be examined at regular intervals for up to three months. We will investigate how fisetin is absorbed and metabolized by the body, and whether fisetin is safe. We will also identify methods to best measure the effect of fisetin on chronic inflammation, senescent cells, and general health.
CONDITIONS
Official Title
Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 20 to 35 years
- suPAR levels below 3.5 ng/mL (± 15% assay variation)
- Ability to cooperate cognitively
- Ability to read and understand Danish
- Women of childbearing potential must use effective contraception
- Older patients aged 65 years or older
- Acutely hospitalized medical patients
- suPAR levels above 5 ng/mL (± 15% assay variation) at screening
- Multimorbidity with two or more chronic diagnoses
- Ability to cooperate cognitively
- Ability to read and understand Danish
- suPAR levels above 5 ng/mL (± 15% assay variation) at 28 days after hospital discharge
You will not qualify if you...
- Body weight over 100 kg
- Inability to swallow pills
- Pregnancy or lactation
- Known allergy or hypersensitivity to fisetin or placebo ingredients
- Any condition that may pose a risk or prevent successful trial completion as judged by the investigator
- Known chronic diagnosis (for healthy volunteers)
- Active acute illness
- Use of prescribed medications except contraceptives (for healthy volunteers)
- Previous cancer diagnosis or treatment (for healthy volunteers)
- Use of senolytic or other "anti-aging" supplements
- Known HIV infection, active hepatitis B or C, or invasive fungal infection (older patients)
- Uncontrolled pleural or pericardial effusions or ascites
- New or active invasive cancer except non-melanoma skin cancers
- Active cancer treatment or disseminated cancer
- Major immunodeficiency conditions
- CRP levels above 30 mg/L at 28 days after discharge (older patients)
- Unstable major disorders such as cardiovascular, renal, endocrine, immunological, hepatic disease, or cancer
- Estimated glomerular filtration rate below 15 ml/min/1.73 m2 or judged at risk of acute kidney injury
- Use of strong CYP3A4 inhibitors or inducers, or medications with narrow therapeutic ranges affecting CYP3A4, CYP2D6, CYP2C9, or CYP2C8 enzymes
- Use of specific drug classes or medications as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Clinical Research, Copenhagen University Hospital Amager & Hvidovre
Hvidovre, Denmark, 2650
Actively Recruiting
Research Team
J
Juliette Tavenier
CONTACT
L
Line Jee Hartmann Rasmussen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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