Tier 4 — mechanistic
A Comparison of Fisetin Kinetics in Young and Old Adults (FISEKIN-1)
ClinicalTrials.gov trial registry record
2025
Bibliography
- Trial registry
- View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
- Funding
- Sponsor: University Medicine Greifswald. The registry record does not identify a separate external funding source.
- Competing interests
- Not reported in the trial registry; no peer-reviewed results manuscript is available for a manuscript-level conflict-of-interest statement.
Study snapshot
| Design | Open-label, randomized crossover, two-cohort, four-condition single-dose pharmacokinetic study comparing younger and older adults under fed and fasted conditions. |
|---|---|
| Model | Cohort 1: adults aged 18–30 years (n=40). Cohort 2: adults aged 65 years or older (n=40). Healthy volunteers are accepted, including some mild or well-controlled conditions under the registry criteria. |
| Sample | Estimated enrollment: 80 participants. |
| Intervention | Single oral 500 mg fisetin dose as Novusetin® (5 capsules) with 240 mL water under fasted and fed conditions. Fed visits use an FDA-style high-calorie, high-fat meal. Each participant undergoes fed and fasted conditions in randomized order. |
| Duration | Two single-dose pharmacokinetic visits per participant in randomized order, separated by a washout of at least 1 week; serial blood sampling through 10 hours after each dose. |
| Endpoints | Primary: fisetin plasma AUC0-10h comparing younger versus older adults in fasted and fed conditions; Fisetin metabolite AUC0-10h; Cmax; Tmax; Total and renal clearance; Apparent volume of distribution; Fed-versus-fasted pharmacokinetic differences; Safety monitoring including blood pressure and heart rate |
What the study showed, in plain terms
Key findings
What this study can and cannot tell us
Citation network
Articles citing this research paper
Biohack Blueprint analyses that reference this study in their evidence base.
- How and When to Take FisetinHuman fisetin studies use multiple schedules, and neither a high-fat meal nor morning dosing has been proved superior. This guide separates published...Read analysis
- Fisetin Dosage: What Human Studies Actually UseThere is no single established fisetin dose. Human studies have used 100 mg/day, 200–800 mg/day, 2 mg/kg intermittent dosing, ~20 mg/kg senolytic...Read analysis
- Fisetin: A Clinician's Guide to Evidence, Dose & SafetyFisetin is a plant flavonol with senolytic activity in selected cell and animal models. Human research now spans continuous low-dose regimens, intermittent...Read analysis
- Fisetin Pulse Dosing: What Human Trials Actually UseThere is no single Mayo Clinic fisetin protocol. Human trials use one-, two- and three-day pulses, with repeat intervals ranging from one...Read analysis
- Fisetin Bioavailability: The Flavonoid Absorption ProblemA small human crossover study found greater dose-adjusted fisetin plasma exposure with a specific hybrid-hydrogel formulation than with unformulated fisetin. Neither result...Read analysis
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