Tier 2 — strong

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

DOI: Not applicable — no DOI exists yet
PubMed: PMID Not applicable — no PMID exists yet
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

Design	Randomised, double-blind (participant and investigator), placebo-controlled, parallel-group Phase 2 interventional trial (NCT03430037).
Model	Community-dwelling and skilled-nursing older women with frailty and gait disturbance (Frail Elderly Syndrome), enrolled at Mayo Clinic, Rochester, Minnesota.
Sample	Planned enrollment: 40 participants.
Intervention	Oral fisetin (dietary supplement) versus matching oral placebo capsule.
Duration	Per 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.
Endpoints	Improved 6-minute walk distance; Improved gait speed; One-month follow-up assessment window

What the study showed, in plain terms

AFFIRM is a real, currently enrolling clinical trial at Mayo Clinic (ClinicalTrials.gov identifier NCT03430037), not a completed or published research paper. It is included in the Fisetin Data Center specifically because Biohack Blueprint tracks it as an important trial to watch, and per editorial decision both the AFFIRM and COVID-FIS registry-stage records are catalogued now with their identifiers flagged, so the entry can be upgraded the moment results are published.

The trial is testing whether oral fisetin, compared with placebo, improves physical function — specifically walking distance and gait speed — in frail older women with gait disturbance, alongside markers of inflammation, insulin resistance and bone resorption. It is a Phase 2, randomised, double-blind, placebo-controlled design, which is the right design to eventually produce strong (Tier 1-2) human evidence.

As of the most recent registry update, the trial is still enrolling by invitation, with an estimated primary completion date in late 2026 and full completion projected into 2027. There are no results yet, and none should be implied or inferred from this entry.

This record is a placeholder that must be revisited: no PMID, DOI or peer-reviewed publication exists for AFFIRM at this time, and none of its details should be cited in article body copy as if they were an established finding.

Key findings

No results are available. AFFIRM (NCT03430037) is an actively enrolling trial with no posted or published outcome data as of the last ClinicalTrials.gov update (11 May 2026).
Registered primary outcomes are improvement in 6-minute walk distance and gait speed, assessed at a one-month follow-up window, in frail older women randomised to oral fisetin versus placebo.
This entry should be revisited and upgraded to a full evidence-tier metaobject once trial results are published in a peer-reviewed journal with a verifiable PMID and DOI.

What this study can and cannot tell us

This is a trial registration, not a completed study: there are no results, no peer review, no PMID and no DOI. Nothing about efficacy or safety can be concluded from this record.

The planned sample size (n=40) is small even for a pilot trial, consistent with its stated purpose of informing a larger future trial rather than providing definitive evidence on its own.

Editorial flag: PMID, DOI, PMC ID and PubMed/PMC URLs are explicitly marked not applicable here because none exist yet — per editorial instruction, both missing-identifier trial records (AFFIRM and COVID-FIS) are included in the Data Center now with identifiers flagged, rather than fabricated or omitted, so they can be found and completed later.

Tier 3

Effects of Fisetin Treatment on Cellular Senescence of Various Tissues and Organs of Old Sheep

Huard CA et al. · Antioxidants · 2023