Fisetin for frailty and inflammation in older adults (AFFIRM / AFFIRM-LITE) — ongoing
Human RCT — disease/biomarker endpoint (ongoing, no results)
Record verify: registry-verified; no results published yet
| Design | Phase 2 double-blind randomized placebo-controlled (ongoing) |
| Citation status | Both trials verified via ClinicalTrials.gov v2 API 2026-08-08. AFFIRM (NCT03430037): Mayo Clinic, Phase 2 randomized double-blind placebo-controlled, n=40 estimated, ENROLLING_BY_INVITATION, status verified 2026-05. AFFIRM-LITE (NCT03675724): Mayo Clinic, Phase 2 randomized double-blind placebo-controlled, n=40 estimated, ENROLLING_BY_INVITATION, status verified 2026-04. Neither has published results. |
| Registry | Two registry identifiers apply; see trials[]. A single record-level registry field cannot represent both. |
Identifiers: this record covers more than one registered trial. Identifiers, population, recruitment status and primary outcome are listed separately per trial below, because they differ.
AFFIRM
| Registry | NCT03430037 |
| Official title | AFFIRM: A Phase 2 Randomized, Placebo-Controlled Study of Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Women |
| Sponsor | Mayo Clinic |
| Principal investigator | Robert J. Pignolo |
| Phase | Phase 2 |
| Design | Randomized, parallel-assignment, double-masked (participant, investigator), placebo-controlled |
| Population | Healthy postmenopausal women aged 70 or older (sex: female only) |
| Enrollment | 40 (estimated) |
| Exposure | Oral fisetin 20 mg/kg/day for 2 consecutive days, repeated in 2 consecutive months |
| Primary outcome | Improved 6-minute walk / gait speed, measured at 1 month |
| Recruitment status | enrolling by invitation |
| Status verified | 2026-05 |
| Results published | No |
| Verified via | ClinicalTrials.gov v2 API, 2026-08-08 |
Identifiers: DOI not applicable to this study type; PMID not applicable to this study type; trial registry id verified. Record-level verification and identifier-level status are separate: a record can be fully verified against its primary publication while an identifier that cannot apply to the study type — a trial registry ID for an animal study, for instance — is marked not applicable. No identifier is fabricated, and none is left in a “pending” state.
AFFIRM-LITE
| Registry | NCT03675724 |
| Official title | AFFIRM-LITE: A Phase 2 Randomized, Placebo-Controlled Study of Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Adults |
| Sponsor | Mayo Clinic |
| Principal investigator | Robert J. Pignolo |
| Phase | Phase 2 |
| Design | Randomized, parallel-assignment, double-masked (participant, investigator), placebo-controlled |
| Population | Adults aged 70 or older (sex: all) |
| Enrollment | 40 (estimated) |
| Exposure | Oral fisetin 20 mg/kg/day for 2 consecutive days |
| Primary outcome | Percent decrease in blood inflammation markers, measured at 7 days |
| Recruitment status | enrolling by invitation |
| Status verified | 2026-04 |
| Results published | No |
| Verified via | ClinicalTrials.gov v2 API, 2026-08-08 |
Identifiers: DOI not applicable to this study type; PMID not applicable to this study type; trial registry id verified. Record-level verification and identifier-level status are separate: a record can be fully verified against its primary publication while an identifier that cannot apply to the study type — a trial registry ID for an animal study, for instance — is marked not applicable. No identifier is fabricated, and none is left in a “pending” state.
Not the same study
AFFIRM and AFFIRM-LITE are two separately registered Mayo Clinic trials, not one trial with two names. They differ in enrolled population and in primary outcome measure: AFFIRM enrolls postmenopausal women and measures 6-minute walk / gait speed at 1 month; AFFIRM-LITE enrols adults of both sexes and measures percent change in blood inflammation markers at 7 days. Neither has published results as of the search date, so no efficacy conclusion is available from either.
Five-qualifier claim
| Species / population | Older adults with frailty/multimorbidity (older women in AFFIRM; mixed cohort in AFFIRM-LITE). |
| Exposure, route, schedule | Oral fisetin 20 mg/kg/day for 2 consecutive days in both trials, but AFFIRM repeats the 2-day course in a second consecutive month while AFFIRM-LITE does not. See the per-trial rows. |
| Comparator / duration | Both are randomized, double-masked and placebo-controlled. The measurement points differ: AFFIRM reads out at 1 month, AFFIRM-LITE at 7 days. |
| Endpoint / numeric result | Each trial has its own primary outcome measure -- see the per-trial rows. Both are enrolled/ongoing with no efficacy results published as of the search date. |
| What it did NOT establish | No results — the existence of the trial is not evidence of benefit. |
Interventions
Primary references
One record-level reference URL cannot represent two registered trials; each trial links to its own registry entry.