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Flavonoid
Fisetin for Frailty (AFFIRM-LITE 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
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up seven days
Awards & highlights
AFFIRM-LITE Trial Summary
This trial will test if the anti-inflammatory drug Fisetin can help reduce markers of inflammation, frailty, and insulin resistance in elderly adults.
Who is the study for?
This trial is for people aged 70 or older who are experiencing frailty and inflammation. They must be able to take oral medication and not be on certain drugs that can't be stopped for the duration of the trial, including strong CYP3A4 inhibitors, proton pump inhibitors without a break, or senolytic agents used in the past year. Pregnant individuals, those with specific infections like hepatitis B/C or HIV, recent cancer except non-melanoma skin cancers, and those with certain lab abnormalities cannot join.Check my eligibility
What is being tested?
The study is testing Fisetin's ability to reduce signs of aging such as frailty and inflammation compared to a placebo. Participants will receive either Fisetin capsules or a placebo (a capsule with no active drug) to see if there's an improvement in their condition.See study design
What are the potential side effects?
Potential side effects from Fisetin may include allergic reactions for those sensitive to it. Since this is a pilot study assessing efficacy and safety, detailed side effect profiles will be determined during the trial.
AFFIRM-LITE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 70 years old or older.
AFFIRM-LITE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ seven days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~seven days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decrease in blood inflammation markers
Side effects data
From 2022 Phase 2 trial • 55 Patients • NCT047716117%
Rash
7%
hyperhidrosis
7%
Chest pain
7%
Diarrhea
7%
Sinusitis
7%
Infectious Rash
7%
Back Pain
7%
Headache
7%
Worsening Headache
7%
Dyspnea
7%
sore throat
3%
hypertension
3%
tachycardia
3%
amnesia
3%
asthma with exacerbation
3%
Anosmia
3%
migraine
3%
conjunctivitis
3%
rhinitis
3%
flu like symptoms
3%
Otitis media
3%
vertigo
3%
edema, hand, bilateral
3%
bacterial vaginosis
3%
ear pain, left
3%
cough
3%
Upper Respiratory Infection
3%
Epistaxis
3%
flatulence
3%
shortness of breath
3%
arthoplasty
3%
ageusia
3%
change in smell
3%
vomiting
3%
fatigue
3%
Colic Renal
3%
Nephrolithiasis Calcium Oxalate
3%
sneezing
3%
thrush
3%
right shoulder arthroscopy, rotator cuff, repair
3%
watering eyes (epiphora)
3%
Systolic murmur
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Group
Placebo
AFFIRM-LITE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Fisetin 20mg/kg/day, orally for 2 consecutive days
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsules orally for 2 consecutive days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fisetin
2016
Completed Phase 2
~170
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot or will not stop my proton pump inhibitor medication for 4 days during the Fisetin treatment.I am not taking strong CYP3A4 inhibitors.I have a new or active cancer that is not a non-melanoma skin cancer.I am on medication that interacts with specific liver enzymes.I cannot take medicine by mouth.I have taken quinolone antibiotics in the last 10 days.I haven't taken any senolytic agents like Fisetin or Dasatinib in the last year.I have an invasive fungal or viral infection.My vitamin D level is above 20 ng/ml.I am 70 years old or older.I am currently on or have been treated with tyrosine kinase inhibitor therapy.I am not willing to stop taking my H2-antagonist medication for 3 weeks.I am currently on medication that includes chemotherapy drugs.I am not currently taking any antibiotics or antifungals listed.I can stop my current medications for 2 days to take Fisetin.My weight is over 150 kg or my BMI is over 50.I cannot or do not want to give permission for treatment.I have an active hepatitis B or C infection.I am HIV positive.You have a known allergy or sensitivity to fisetin.I have unmanaged fluid buildup in my chest or abdomen.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Fisetin passed government safety review?
"While there is some evidence of Fisetin's safety, it only received a score of 2 because Phase 2 trials have yet to demonstrate efficacy."
Answered by AI
Are people with the relevant medical condition able to participate in this trial at this time?
"The clinical trial mentioned is still recruiting patients, as seen on the website clinicaltrials.gov. This study was first posted on 15/11/2018 and updated recently on 07/01/2022."
Answered by AI
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