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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03430037
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
James L. Kirkland, MD, PhD, Mayo Clinic

Study Description
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Brief Summary:
This is a pilot study to evaluate whether targeting inflammation will help reduce markers of insulin resistance inflammation, bone resorption and physical dysfunction in elderly women with gait disturbance. Positive results of this study would lead to the development of a larger clinical trial examining the effects of this intervention on age-related dysfunction.

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 postmenopausal women. The researchers plan to evaluate markers of frailty and markers of inflammation, insulin resistance, and bone resorption while maintaining bone formation in older postmenopausal women.
Study Design
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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: A Phase 2 Randomized, Placebo-Controlled Study of Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Women
Actual Study Start Date : February 6, 2018
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Fisetin 20/mg/kg/day, orally for 2 consecutive days, for 2 consecutive months.
 Dietary Supplement: Fisetin
Flavonoid Family
Placebo Comparator: Placebo
Placebo capsules orally for 2 consecutive days, for 2 consecutive months.
 Drug: Placebo oral capsule
Placebo
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Improved 6 minute walk [ Time Frame: One Month ]
    Improved gait speed


Eligibility Criteria
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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:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Healthy postmenopausal women
  • Age ≥ 70 years

Exclusion Criteria

  • Abnormality in any of the screening laboratory studies (see below)
  • Presence of significant liver or renal disease
  • Malignancy (including myeloma)
  • Malabsorption
  • Hypoparathyroidism
  • Hyperparathyroidism
  • Acromegaly
  • Cushing's syndrome
  • Hypopituitarism
  • Gastric bypass/reduction
  • Malabsorption issues
  • Crohn's
  • Myopathies (increased or low calcium, vitamin D deficiency, elevated creatine kinase or ESR)
  • If diabetic AND on sulfonylureas (like glipizide, glimepiride, glyburide), SGLT2 inhibitors (like dapagliflozin and empagliflozin), or insulin

  • Undergoing treatment with any medications that affect bone turnover, including the following:

    • adrenocorticosteroids (> 3 months at any time or > 10 days within the previous yr), anticonvulsant therapy (within the previous year),
    • pharmacological doses of thyroid hormone (causing decline of thyroid stimulating hormone below normal),
    • calcium supplementation of > 1200 mg/d (within the preceding 3 months),
    • bisphosphonates (within the past 3 yrs),
    • denosumab,
    • estrogen (E) therapy or treatment with a selective E receptor modulator, or teriparatide (within the past yr).
  • Subjects with a fracture within the past year
  • 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
  • QTc >450 msec
  • Inability to provide informed consent
  • Total bilirubin >2X upper limit
  • Inability to tolerate oral medication
  • eGFR < 15 ml/ min/ 1.73 m2
  • 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.
Contacts and Locations
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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): NCT03430037


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

Locations
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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
Investigators
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Principal Investigator: James L Kirkland, MD, PhD Mayo Clinic
Principal Investigator: Sundeep Khosla, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: James L. Kirkland, MD, PhD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03430037    
Other Study ID Numbers: 17-000472
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Inflammation
Frailty
Additional relevant MeSH terms:
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Inflammation
Frailty
Pathologic Processes