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Flavonoid

Fisetin for Frailty (AFFIRM Trial)

Phase 2

Waitlist Available

Led By James L Kirkland, MD, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 70 years

Healthy postmenopausal women

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one month

Awards & highlights

AFFIRM Trial Summary

This trial will test if reducing inflammation will help improve insulin resistance, bone loss, and physical function in elderly women with walking problems. If it works, a larger clinical trial will be done.

Who is the study for?

This trial is for healthy postmenopausal women aged 70 or older with gait disturbances. It's not for those with significant liver/renal disease, malabsorption issues, certain hormonal disorders, recent fractures, or on medications affecting bone turnover or inducing cellular senescence.Check my eligibility

What is being tested?

The study tests if Fisetin can reduce inflammation and improve insulin resistance, bone health, and physical function in elderly women. Participants will receive either Fisetin or a placebo to assess the potential benefits of this intervention.See study design

What are the potential side effects?

While specific side effects are not listed here, participants may experience reactions related to the supplement Fisetin. Typically such supplements could cause digestive discomfort among other mild symptoms.

AFFIRM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 70 years old or older.

Select...

I am a healthy woman who has gone through menopause.

AFFIRM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one month

This trial's timeline: 3 weeks for screening, Varies for treatment, and one month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improved 6 minute walk

Side effects data

From 2022 Phase 2 trial • 55 Patients • NCT04771611

Rash

hyperhidrosis

Chest pain

Diarrhea

Sinusitis

Infectious Rash

Back Pain

Headache

Worsening Headache

Dyspnea

sore throat

hypertension

tachycardia

amnesia

asthma with exacerbation

Anosmia

migraine

conjunctivitis

rhinitis

flu like symptoms

Otitis media

vertigo

edema, hand, bilateral

bacterial vaginosis

ear pain, left

cough

Upper Respiratory Infection

Epistaxis

flatulence

shortness of breath

arthoplasty

ageusia

change in smell

vomiting

fatigue

Colic Renal

Nephrolithiasis Calcium Oxalate

sneezing

thrush

right shoulder arthroscopy, rotator cuff, repair

watering eyes (epiphora)

Systolic murmur

100%

80%

60%

40%

20%

Study treatment Arm

Treatment Group

Placebo

AFFIRM Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Fisetin 20/mg/kg/day, orally for 2 consecutive days, for 2 consecutive months.

Group II: PlaceboPlacebo Group1 Intervention

Placebo capsules orally for 2 consecutive days, for 2 consecutive months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fisetin

2016

Completed Phase 2

~170

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,744 Total Patients Enrolled

James L Kirkland, MD, PhDPrincipal InvestigatorMayo Clinic

4 Previous Clinical Trials

195 Total Patients Enrolled

Sundeep Khosla, MDPrincipal InvestigatorMayo Clinic

6 Previous Clinical Trials

846 Total Patients Enrolled

Media Library

Fisetin (Flavonoid) Clinical Trial Eligibility Overview. Trial Name: NCT03430037 — Phase 2

Frailty Syndrome Research Study Groups: Treatment, Placebo

Frailty Syndrome Clinical Trial 2023: Fisetin Highlights & Side Effects. Trial Name: NCT03430037 — Phase 2

Fisetin (Flavonoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03430037 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration sanctioned Fisetin for medicinal use?

"Our experts at Power rated Fisetin as a 2, since there is limited evidence supporting its safety but none demonstrating efficacy."

Answered by AI

How many participants is this clinical investigation recruiting?

"Affirmative. On the clinicaltrials.gov website, it is indicated that this research project initiated on February 6th 2018 and was recently updated in January of 2022. Approximately 40 participants are being sought out from a single medical site."

Answered by AI

Does this investigation have capacity to accept new participants?

"True, according to the information on clinicaltrials.gov, this clinical trial is actively recruiting candidates. Initially posted on February 6th 2018 and recently amended in January 7th 2022, it seeks 40 test subjects from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

James L. Kirkland, MD, PhD 2018. "Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03430037.