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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 : Not yet recruiting
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
James L. Kirkland, 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.

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
Estimated Study Start Date : September 28, 2018
Estimated Primary Completion Date : September 28, 2019
Estimated Study Completion Date : April 28, 2020

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
Placebo




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 to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 dasatinib or quercetin
  • Subjects on quinolone antibiotic therapy for treatment or for prevention of infections within 10 days.
  • Subjects taking H2-antagonists or proton pump inhibitors 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 on therapeutic doses of anticoagulants (e.g., warfarin, heparin, low molecular weight heparin, factor Xa inhibitors, etc.)
  • 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 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, thyroid hormones, eluxadoline, eltrombopag, nitroglycerin, pioglitazone, glyburide, enzalutamide, ezetimibe, colchicine, imatinib, cyclosporine, tacolimus, sirolimus, carbamazepine, flecainide, phenytoin, phenobarbital, rifampicin, theophylline, warfarin, heparin, full dose ASA, clopidogrel, 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.

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


Contacts
Contact: Tammie Volkman, RN 507-266-1944 volkman.tammie@mayo.edu
Contact: Erin Wissler Gerdes 507-266-1944 wisslergerdes.erin@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Tammie Volkman, RN    507-266-1944    volkman.tammie@mayo.edu   
Contact: Erin Wissler Gerdes    507-266-1944    wisslergerdes.erin@mayo.edu   
Principal Investigator: James Kirkland, MD, PhD         
Principal Investigator: Sundeep Khosla, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: James L Kirkland, MD, PhD Mayo Clinic
Principal Investigator: Sundeep Khosla, MD Mayo Clinic

Responsible Party: James L. Kirkland, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03675724     History of Changes
Other Study ID Numbers: 18-007332
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James L. Kirkland, Mayo Clinic:
Frailty
Inflammation
Elderly
Aging

Additional relevant MeSH terms:
Inflammation
Pathologic Processes