Tier 4 — mechanistic

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

Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
ClinicalTrials.gov lead sponsor/responsible party: Ove Andersen, Hvidovre University Hospital. Collaborators: University of Southern Denmark and Mayo Clinic.
Competing interests
Not disclosed in the ClinicalTrials.gov registry record; no funding-source conflicts are indicated.

Study snapshot

DesignRandomised, parallel-group, quadruple-blind (participant, care provider, investigator, outcomes assessor), placebo-controlled Phase 1/2 interventional trial.
ModelHuman participants: healthy volunteers and older patients with multimorbidity.
SamplePlanned enrollment: 60 participants.
InterventionOral fisetin versus placebo, administered for two days, with follow-up assessments at regular intervals for up to three months.
DurationTwo-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).
EndpointsPopulation-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

Fisetin HIGH (NCT06431932) is an ongoing Danish Phase 1/2a human study with a healthy-volunteer pharmacokinetic cohort and a randomized placebo-controlled cohort of older adults with multimorbidity. It is designed to measure fisetin pharmacokinetics, safety and senescence/inflammation-related biomarkers.

No outcome results are posted or published. The registry can therefore support descriptions of the design, dose and recruitment status but not claims that fisetin improves multimorbidity, frailty or cellular senescence in people.

Key findings

  • No efficacy results are available.
  • Current 2026 sources describe 60 planned participants across the healthy-volunteer and older-patient cohorts.
  • The study includes pharmacokinetic, safety and senescence/inflammation biomarker outcomes.

What this study can and cannot tell us

  • Ongoing registry-stage study with no outcome dataset.
  • The healthy-volunteer and older-multimorbidity cohorts have different designs and should not be collapsed into one efficacy population.
  • Registry dosing and biomarker plans are experimental and do not establish a recommended supplement regimen.

Citation network

Articles citing this research paper

7 articles

Biohack Blueprint analyses that reference this study in their evidence base.

Editorial review

Reviewed by the Biohack Blueprint research team

Last verified