Tier 4 — mechanistic

Fisetin to Improve Vascular Function in Older Adults

Matthew J. Rossman
ClinicalTrials.gov trial registry record 2023

Bibliography

Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Sponsor: University of Colorado, Boulder. Collaborator: American Heart Association.
Competing interests
Not reported in the ClinicalTrials.gov registry record; no peer-reviewed results manuscript is available for a manuscript-level conflict-of-interest statement.

Study snapshot

DesignRandomized, double-blind, placebo-controlled, parallel-group Phase 1/2 trial with triple masking of participant, investigator, and outcomes assessor.
ModelAdults aged 65 years and older; healthy volunteers accepted.
SampleEstimated enrollment: 70 participants.
InterventionFisetin 2 mg/kg/day for 3 consecutive days, followed by a second 3-day course two weeks later, versus identical placebo.
DurationStudy start 2023-09-25; primary completion estimated 2026-03-31; study completion estimated 2027-03-31. Primary vascular endpoint assessed at 1 month.
EndpointsPrimary: change in brachial artery flow-mediated dilation at 1 month; Secondary: change in carotid-femoral pulse wave velocity at 1 month; Endothelial and blood-cell senescence markers including p16 and p21; Circulating SASP factors; Mitochondrial oxidative-stress contribution to endothelial dysfunction; Safety, tolerability and adherence

What the study showed, in plain terms

This Phase 1/2 trial tests a substantially lower intermittent fisetin regimen than the commonly cited 20 mg/kg senolytic protocol: 2 mg/kg/day for three days, repeated after two weeks. It is designed to test vascular endothelial function, aortic stiffness, cellular senescence, SASP-related biology and safety in adults aged 65 years and older.

Key findings

The registered protocol confirms that contemporary human fisetin research is not limited to 20 mg/kg. The study uses 2 mg/kg/day in two short three-day courses separated by two weeks. No outcome results are posted yet.

What this study can and cannot tell us

This is a ClinicalTrials.gov registry record rather than a completed peer-reviewed results paper. The dose and design can be described, but no efficacy conclusion should be drawn until results are reported.

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