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History of Changes for Study: NCT03430037
Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Women (AFFIRM)
Latest version (submitted January 7, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 9, 2018 None (earliest Version on record)
2 September 17, 2018 Contacts/Locations and Study Status
3 February 20, 2020 Study Status, Eligibility and References
4 February 22, 2021 Contacts/Locations, Study Status and Sponsor/Collaborators
5 January 7, 2022 Study Status
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Study NCT03430037
Submitted Date:  February 9, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: 17-000472
Brief Title: Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Women (AFFIRM)
Official Title: AFFIRM: A Phase 2 Randomized, Placebo-Controlled Study of Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Women
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2018
Overall Status: Recruiting
Study Start: February 6, 2018
Primary Completion: December 31, 2019 [Anticipated]
Study Completion: June 30, 2020 [Anticipated]
First Submitted: February 5, 2018
First Submitted that
Met QC Criteria:
February 9, 2018
First Posted: February 12, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
February 9, 2018
Last Update Posted: February 12, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Mayo Clinic
Responsible Party: Principal Investigator
Investigator: James L. Kirkland
Official Title: Principal Investigator
Affiliation: Mayo Clinic
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
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.
Open or close this module Conditions
Conditions: Frail Elderly Syndrome
Keywords: Inflammation
Frailty
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • Placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Improved 6 minute walk
[ Time Frame: One Month ]

Improved gait speed
Open or close this module Eligibility
Minimum Age: 70 Years
Maximum Age: 90 Years
Sex: Female
Gender Based: 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
  • Diabetes
  • Hypoparathyroidism
  • Hyperparathyroidism
  • Acromegaly
  • Cushing's syndrome
  • Hypopituitarism
  • Myopathies (increased or low calcium, vitamin D deficiency, elevated creatine kinase or ESR)
  • Undergoing treatment with medications that affect insulin sensitivity, including the following:
    • Metformin (within the previous week),
    • Glucocorticoids (within the previous month),
    • Acarbose (within the previous week)
  • 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 anti-inflammatory drugs within the last year, such as Fisetin
  • Subjects currently taking drugs that induce inflammation: alkylating agents, anthracyclines, platins, other chemotherapy
  • QTc >450 msec
  • Tobacco use (smoking or chewing)
  • Inability to provide informed consent
  • Total bilirubin > twice the upper limit of normal
  • 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, tacrolimus, sirolimus, carbamazepine, flecainide, phenytoin, phenobarbital, rifampicin, theophylline, warfarin, heparin, full dose acetylsalicylic acid (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 periods. Due to drug-drug interaction, subjects may not clear the caffeine from their system properly/as usual.

Open or close this module Contacts/Locations
Central Contact Person: Tammie L Volkman, RN
Telephone: 507-266-1944
Email: volkman.tammie@mayo.edu
Central Contact Backup: Tamara K Evans
Telephone: 507-266-1944
Email: evans.tamara@mayo.edu
Study Officials: James L Kirkland, MD, PhD
Principal Investigator
Mayo Clinic
Sundeep Khosla, MD
Principal Investigator
Mayo Clinic
Locations: United States, Minnesota
Mayo Clinic in Rochester
[Recruiting]
Rochester, Minnesota, United States, 55905
Contact:Contact: Tammie L Volkman, RN 507-266-1944 volkman.tammie@mayo.edu
Contact:Contact: Tamara K Evans 507-266-1944 evans.tamara@mayo.edu
Contact:Principal Investigator: James Kirkland, MD, PhD
Contact:Principal Investigator: Sundeep Khosla, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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