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

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ClinicalTrials.gov Identifier: NCT03675724
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : January 26, 2023
Information provided by (Responsible Party):
James L. Kirkland, MD, PhD, Mayo Clinic

Brief Summary:
This is a pilot study to test the efficacy of the anti-inflammatory drug (Fisetin) in reducing inflammatory factors in blood in elderly adults and to test the efficacy of the drug (Fisetin) in reducing frailty and markers of inflammation, insulin resistance, and bone resorption in elderly adults.

Condition or disease Intervention/treatment Phase
Frail Elderly Syndrome Dietary Supplement: Fisetin Drug: Placebo oral capsule Phase 2

Detailed Description:
To the researchers' knowledge, there are no published studies utilizing Fisetin in alteration of frailty markers. Several studies involve use of Fisetin for its anti-oxidative and anti-apoptotic effects in animal models. Fisetin may reduce oxidative stress, alleviate hyperglycemia, and improve kidney function. No one has evaluated the biologic markers of inflammation and frailty in older adults. The researchers plan to evaluate markers of frailty and markers of inflammation, insulin resistance, and bone resorption while maintaining bone formation in older adults.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: AFFIRM-LITE: A Phase 2 Randomized, Placebo-Controlled Study of Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Adults
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
Experimental: Treatment
Fisetin 20mg/kg/day, orally for 2 consecutive days
Dietary Supplement: Fisetin
Flavonoid Family

Placebo Comparator: Placebo
Placebo capsules orally for 2 consecutive days
Drug: Placebo oral capsule

Primary Outcome Measures :
  1. Decrease in blood inflammation markers [ Time Frame: Seven Days ]
    Percent decrease in blood inflammation markers

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

• Age ≥ 70 years

Exclusion Criteria

  • Unable or unwilling to give informed consent
  • Pregnant
  • Body weight >150 kg or body mass index (BMI) > 50
  • QTc>450 msec
  • Total bilirubin >2X upper limit of normal
  • Inability to tolerate oral medication
  • Abnormality in any of the screening laboratory studies (see below)
  • Human immunodeficiency virus infection
  • Known active hepatitis B or C infection
  • Invasive fungal or viral infection
  • Known hypersensitivity or allergy to fisetin
  • Uncontrolled pleural/pericardial effusions or ascites
  • New/active invasive cancer except non-melanoma skin cancers
  • Subjects taking medications that are sensitive to substrates or substrates with a narrow therapeutic range for CYP3A4, CYP2C8, CYP2C9, or CYP2D6 or strong inhibitors or inducers of CYP3A4 (e.g. cyclosporine, tacrolimus or sirolimus). If antifungals are absolutely necessary from an infectious disease perspective, then they will be allowed only if the levels are therapeutic.
  • Strong inhibitors of CYP3A4. See Appendices 1-3.
  • Tyrosine kinase inhibitor therapy
  • Known hypersensitivity or allergy to fisetin
  • Subjects on quinolone antibiotic therapy for treatment or for prevention of infections within 10 days.
  • Subjects taking H2-antagonists and unwilling to discontinue therapy for 1 week before and 2 weeks following enrollment.
  • Subjects taking potentially senolytic agents within the last year: Fisetin, Quercetin, Luteolin, Dasatinib, Piperlongumine, or Navitoclax
  • Subjects currently taking drugs that induce cellular senescence: alkylating agents, anthracyclines, platins, other chemotherapy
  • Subjects taking the following antimicrobial agents: Aminoglycosides, Azole antifungals (fluconazole, miconazole, voriconazole, itraconazole), Macrolides (clarithromycin,erythromycin), Antivirals (nelfinavir, indinavir, saquinavir, ritonavir, elbasvir/grazoprevir), Rifampin
  • Subjects taking proton pump inhibitors who are unable or unwilling to reduce or hold therapy 2 days prior to and during the 2-day Fisetin dosing
  • Subjects taking the following other drugs if they cannot be held for at least 2 days before and during administration of Fisetin: digoxin, lithium, all statins, repaglidine, bosentan, gemfibrozil, olmesartan, enalapril, valsartan, methotrexate, corticosteroids, , eluxadoline, eltrombopag, nitroglycerin, pioglitazone, glyburide, enzalutamide, ezetimibe, colchicine, imatinib, cyclosporine, tacolimus, sirolimus, carbamazepine, flecainide, phenytoin, phenobarbital, rifampicin, theophylline, celecoxib, desipramine, thioridazine, venlafaxine, tizanidine, atomoxetine, voriconazole, citalopram, diazepam, escitalopram, propranolol, clozapine, cyclobenzaprine, mexiletine, olanzapine, ondansetron, riluzole
  • In order to ensure vitamin D sufficiency, we will also exclude subjects with serum 25-hydroxyvitamin D levels of < 20 ng/ml.
  • Presence of any condition that the Investigator believes would put the subject at risk or would preclude the patient from successfully completing all aspects of the trial.

Behavioral Modification - Participants will be educated about the risk of excessive caffeine usage. Participants will be encouraged to reduce use by 50% prior to and during the 2-day drug dosing period. Due to drug-drug interaction, subjects may not clear the caffeine from their system properly/as usual.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675724

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Contact: Tamara K Evans 507-284-1004 evans.tamara@mayo.edu

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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tamara K Evans    507-284-1004    evans.tamara@mayo.edu   
Principal Investigator: James Kirkland, MD, PhD         
Principal Investigator: Sundeep Khosla, MD         
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: James L Kirkland, MD, PhD Mayo Clinic
Principal Investigator: Sundeep Khosla, MD Mayo Clinic
Additional Information:
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Responsible Party: James L. Kirkland, MD, PhD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03675724    
Other Study ID Numbers: 18-007332
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James L. Kirkland, MD, PhD, Mayo Clinic:
Additional relevant MeSH terms:
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Pathologic Processes