Tier 4 — mechanistic

Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Adults (AFFIRM-LITE)

Robert J. Pignolo
ClinicalTrials.gov trial registry record 2018

Bibliography

Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Sponsor: Mayo Clinic.
Competing interests
Not reported in the ClinicalTrials.gov registry record; no peer-reviewed results manuscript is available.

Study snapshot

DesignPhase 2 randomized, double-blind, placebo-controlled parallel-group trial.
ModelAdults aged 70 years and older with frailty-related outcomes.
SampleEstimated enrollment: 40 participants.
InterventionFisetin 20 mg/kg/day orally for 2 consecutive days versus placebo.
DurationShort-course dosing with follow-up for frailty, inflammation and senescence-related outcomes; registry estimates study completion in 2027.
EndpointsFrailty and physical-function measures; Markers of cellular senescence; Inflammation; Insulin resistance; Bone turnover

What the study showed, in plain terms

AFFIRM-LITE is a Mayo Clinic Phase 2 trial testing a short two-day fisetin course against placebo in older adults. It focuses on frailty, inflammation and senescence-related biomarkers.

The registry lists the study as enrolling by invitation in 2026. No outcome results are posted, so the record supports the trial design and dose only, not a conclusion that fisetin improves frailty or clears senescent cells in people.

Key findings

  • Registered dose: fisetin 20 mg/kg/day for two consecutive days.
  • Estimated enrollment is 40 adults aged 70 years or older.
  • The study remained in the clinical pipeline in 2026 with no posted results.

What this study can and cannot tell us

  • Registry record only; no efficacy results are available.
  • Small early-phase sample limits the strength of any future single-trial conclusion.
  • Trial dosing should not be converted into a personal supplementation recommendation.

Editorial review

Reviewed by the Biohack Blueprint research team

Last verified

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