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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03430037
Other study ID # 17-000472
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date February 6, 2018
Est. completion date October 2024

Study information

Verified date February 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date October 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender Female
Age group 70 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Fisetin
Flavonoid Family
Drug:
Placebo oral capsule
Placebo

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improved 6 minute walk Improved gait speed One Month
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