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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 : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
James L. Kirkland, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE September 17, 2018
First Posted Date  ICMJE September 18, 2018
Last Update Posted Date February 24, 2020
Actual Study Start Date  ICMJE November 15, 2018
Estimated Primary Completion Date September 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
Decrease in blood inflammation markers [ Time Frame: Seven Days ]
Percent decrease in blood inflammation markers
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Adults
Official Title  ICMJE AFFIRM-LITE: A Phase 2 Randomized, Placebo-Controlled Study of Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Adults
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Frail Elderly Syndrome
Intervention  ICMJE
  • Dietary Supplement: Fisetin
    Flavonoid Family
  • Drug: Placebo oral capsule
    Placebo
Study Arms  ICMJE
  • Experimental: Treatment
    Fisetin 20mg/kg/day, orally for 2 consecutive days
    Intervention: Dietary Supplement: Fisetin
  • Placebo Comparator: Placebo
    Placebo capsules orally for 2 consecutive days
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 17, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 28, 2021
Estimated Primary Completion Date September 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tammie Volkman, RN 507-266-1944 volkman.tammie@mayo.edu
Contact: Erin Wissler Gerdes 507-266-1944 wisslergerdes.erin@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03675724
Other Study ID Numbers  ICMJE 18-007332
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James L. Kirkland, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James L Kirkland, MD, PhD Mayo Clinic
Principal Investigator: Sundeep Khosla, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP