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

NCT ID: NCT03430037

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-06
• Study Completion Date: 2027-04-30

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.

Conditions

Frail Elderly Syndrome

Keywords

Inflammation; Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment

Fisetin 20/mg/kg/day, orally for 2 consecutive days, for 2 consecutive months.

Group Type: EXPERIMENTAL

Fisetin

Intervention Type: DIETARY_SUPPLEMENT

Flavonoid Family

Placebo

Placebo capsules orally for 2 consecutive days, for 2 consecutive months.

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Placebo

Interventions

Fisetin

Flavonoid Family

Intervention Type: DIETARY_SUPPLEMENT

Placebo oral capsule

Placebo

Intervention Type: DRUG

Other Intervention Names

Placebo

Eligibility 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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Robert J. Pignolo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert J Pignolo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Sundeep Khosla, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

17-000472

Identifier Type: -

Identifier Source: org_study_id