Tier 4 — mechanistic

Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Women (AFFIRM)

AFFIRM Trial
ClinicalTrials.gov (trial registry record — not yet published in a peer-reviewed journal) 2018 Not applicable — registry record

Bibliography

Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Sponsor: Mayo Clinic. Funder type: Other (per ClinicalTrials.gov record). No further funding detail available from the registry entry.
Competing interests
Not disclosed in the ClinicalTrials.gov record; no results or manuscript are yet available to review for conflicts of interest.

Study snapshot

DesignRandomised, double-blind (participant and investigator), placebo-controlled, parallel-group Phase 2 interventional trial (NCT03430037).
ModelCommunity-dwelling and skilled-nursing older women with frailty and gait disturbance (Frail Elderly Syndrome), enrolled at Mayo Clinic, Rochester, Minnesota.
SamplePlanned enrollment: 40 participants.
InterventionOral fisetin (dietary supplement) versus matching oral placebo capsule.
DurationPer the registry record: study start 2018-02-06; estimated primary completion November 2026; estimated study completion November 2027. Status as of last registry update (11 May 2026): Enrolling by Invitation.
EndpointsImproved 6-minute walk distance; Improved gait speed; One-month follow-up assessment window

What the study showed, in plain terms

AFFIRM (NCT03430037) is an ongoing Mayo Clinic Phase 2 randomized, double-blind, placebo-controlled trial in older women with frailty or gait disturbance. It tests intermittent oral fisetin against placebo, with physical-function measures and several inflammation, metabolic and bone-related outcomes.

The study is enrolling by invitation and has no posted or peer-reviewed outcome results. The current registry lists estimated enrollment of 40 participants, estimated primary completion in November 2026 and estimated study completion in November 2027.

Because this is a registry record rather than a results publication, it can support descriptions of the trial design, dose and status but cannot be cited as evidence that fisetin improves frailty, inflammation or physical function.

Key findings

  • No efficacy or safety results are available from AFFIRM.
  • The registered primary physical-function outcomes include 6-minute walk performance and gait speed after randomized fisetin versus placebo.
  • ClinicalTrials.gov lists the study as enrolling by invitation, with estimated enrollment of 40 participants and estimated primary completion in November 2026.

What this study can and cannot tell us

  • Trial registry record only: no completed results publication, PMID or DOI is available.
  • The planned sample is small and the trial is designed as an early Phase 2 study rather than definitive evidence of clinical benefit.
  • Registry design details may change before study completion; efficacy and safety conclusions require posted or peer-reviewed outcome data.

Related papers in the corpus

Tier 3
Effects of Fisetin Treatment on Cellular Senescence of Various Tissues and Organs of Old Sheep
Huard CA et al. · Antioxidants · 2023

Citation network

Articles citing this research paper

12 articles

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Editorial review

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology