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

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ClinicalTrials.gov Identifier: NCT03430037
Recruitment Status : Recruiting
First Posted : February 12, 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 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 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 : December 31, 2019
Estimated Study Completion Date : June 30, 2020

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




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



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:   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
  • 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.


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
Contact: Tammie L 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 Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tammie L 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: NCT03430037     History of Changes
Other Study ID Numbers: 17-000472
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Inflammation
Frailty

Additional relevant MeSH terms:
Inflammation
Pathologic Processes