Tier 2 — strong

Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity (Fisetin HIGH)

Andersen O

Not applicable - trial registered on ClinicalTrials.gov (not yet published in a peer-reviewed journal) 2024 Not applicable (trial registry record, no journal volume/issue/pages)

Bibliography

DOI: NOT AVAILABLE - unpublished trial registration, no DOI assigned
PubMed: PMID NOT AVAILABLE - unpublished trial registration, no PMID assigned
Funding: Sponsor: University of Southern Denmark. Collaborators: Mayo Clinic. Other IDs: Fisetin HIGH; 2023-506284-34-00.
Competing interests: Not disclosed in the ClinicalTrials.gov registry record; no funding-source conflicts are indicated.

Study snapshot

Design	Randomised, parallel-group, quadruple-blind (participant, care provider, investigator, outcomes assessor), placebo-controlled Phase 1/2 interventional trial.
Model	Human participants: healthy volunteers and older patients with multimorbidity.
Sample	Planned enrollment: 60 participants.
Intervention	Oral fisetin versus placebo, administered for two days, with follow-up assessments at regular intervals for up to three months.
Duration	Two-day dosing period with follow-up to approximately 3 months (day 84); estimated study start 2026-03-24, primary completion and full completion both estimated 2028-12-31 (registry data).
Endpoints	Population-based pharmacokinetic (popPK) model for fisetin and its metabolites; Adverse events and symptoms/vital sign changes; Soluble urokinase plasminogen activator receptor (suPAR) and other SASP/inflammation markers; Senescence markers (p16INK4a, p21CIP1/WAF1, SA-beta-gal) in immune cells and tissue biopsies; Senolysis markers and aging markers (alpha-klotho, FGF21); Frailty indices, physical function, cognitive function (MoCA, DSST) and quality of life (EQ-5D-5L)

What the study showed, in plain terms

This is not yet a published research paper - it is a clinical trial that is currently recruiting (registered on ClinicalTrials.gov as NCT06431932), being run by researchers in Denmark in collaboration with the Mayo Clinic in the United States.

The trial aims to give short-course oral fisetin (or a placebo) to both healthy volunteers and older adults with multiple chronic conditions, then track them closely for up to three months to see how the body absorbs and processes fisetin, whether it is safe, and how it affects a wide range of biological markers of ageing, inflammation and cellular senescence.

This is exactly the kind of controlled human trial the field has been waiting for, since almost all of the senolytic evidence for fisetin so far comes from animal and cell studies. Until results are published, though, there is no human efficacy or long-term safety data from this specific trial to report.

We are including this record now, with its trial registration details rather than a PMID or DOI, so the Data Center can be updated with the completed results as soon as they are published.

Key findings

No results are available yet - this trial is registered as RECRUITING and has not been completed or published
Planned design: randomised, quadruple-blind, placebo-controlled Phase 1/2 trial in 60 participants
Planned outcomes include fisetin pharmacokinetics, safety, and senescence/inflammation/frailty biomarkers
This entry will need updating with a PMID and DOI once results are published in a peer-reviewed journal

What this study can and cannot tell us

This is a trial registration record, not a peer-reviewed publication - no results, statistical analysis, or conclusions currently exist for this study.

Estimated study dates (start 2026, completion 2028, per the registry) mean published results are not expected for some time; this Data Center entry should be revisited and upgraded once a results publication with a PMID/DOI becomes available.