Clinical trial NCT04258410: Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency
Official title: Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency (QUICKENED) Feasibility Study in Older Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Menopause Related Conditions
Keywords: estrogen deficiency
post-menopause
cardiac diastolic function
skeletal muscle function
skeletal muscle structure
cardiac structure
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized controlled parallel pilot trial of Quercetin vs placebo oral administration in 24 postmenopausal women.
Primary purpose: PREVENTION

Brief summary: Double blind randomized controlled parallel pilot trial of Quercetin vs placebo oral administration in 24 postmenopausal women. The study team will conduct a feasibility pilot in preparation for a larger efficacy trial that will test the protective effects of quercetin against cardiac and skeletal muscle dysfunction and changes in structure induced by estrogen loss and potential mechanistic pathways in post-menopausal women at risk of heart failure with preserved ejection fraction (HFPEF).

Detailed description: Participants receive either oral Quercetin 1000 g/day or placebo for 20 weeks. Quercetin levels, biomarkers, ultrasounds (heart and muscle), functional assessments will be measured on enrollment and after the intervention. The study coordinator will contact participants weekly to monitor safety and ensure compliance. All quercetin administration will be supervised by Claudia L Campos, MD, Associate Professor of Internal Medicine, Medical Director Internal Medicine clinic.

Eligibility criteria: Inclusion Criteria:

* Female, postmenopausal, aged 60 to 74
* Stated willingness to comply with all study procedures and availability for the duration of the study
* High risk of Heart failure with preserved ejection fraction (HFPEF) using web-based Primary Care Physician-HF risk tool (Khan S, et al.10-Year Risk Equations for Incident Heart Failure in the General Population. Information used for calculation include: age, gender, race, hypertension treatment (yes or no), fasting glucose value, smoking status, body mass index, systolic BP, diabetes treatment (yes or no), total cholesterol, HDL cholesterol, and electrocardiogram QRS duration. Prospective participant's with scores \>= 10% will be included.
* Electrocardiogram (EKG) on medical record

Exclusion Criteria:

* History of congestive heart failure or use of loop diuretics
* Recent myocardial infarction (MI), stroke, angina, or atrial fibrillation (in the past 6 months), either self-reported and or in the electronic medical record.
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension
* Significant renal insufficiency requiring dialysis or estimated glomerular filtration rate (eGFR) \< 15 mL/min
* Liver disease
* Psychiatric disease - uncontrolled major psychoses, depressions, dementia, or personality disorder
* Participants reporting extreme energy intakes \>3500 or \<500 kcal/day
* Plans to leave area within the study period
* Refuses informed consent

Primary outcomes:
measure: Feasibility: Number of enrolled participants per month
timeFrame: up through 13 months
measure: Eligibility: Proportion eligible after screening
timeFrame: baseline
Secondary outcomes:
measure: Adherence: Percent adherence to study visits
timeFrame: 20 weeks
measure: Adherence: Percent adherence to intervention
timeFrame: 20 weeks
measure: Retention: Number of Subjects Lost to Follow Up
timeFrame: 20 weeks
measure: Retention: Number of Subjects Discontinued
timeFrame: 20 weeks
measure: Acceptability: Changes in patient satisfaction
timeFrame: Baseline and week 20
Other outcomes:
measure: Changes in left ventricular systolic function
timeFrame: Baseline and 20 weeks
measure: Changes in left ventricular diastolic function
timeFrame: Baseline and 20 weeks
measure: Changes in left ventricular filling pressure
timeFrame: Baseline and 20 weeks
measure: Changes in left ventricular (LV) structure
timeFrame: Baseline and 20 weeks
measure: Changes in left atrial structure
timeFrame: Baseline and 20 weeks
measure: Changes in skeletal muscle quality
timeFrame: Baseline and 20 weeks
measure: Changes in skeletal muscle composition
timeFrame: Baseline and 20 weeks
measure: Changes in exercise capacity
timeFrame: Baseline and 20 weeks
measure: Changes in skeletal muscle strength
timeFrame: Baseline and 20 weeks
measure: Changes in biomarker of inflammation
timeFrame: Baseline and 20 weeks
measure: Changes in biomarker of oxidative stress
timeFrame: Baseline and 20 weeks
measure: Changes in biomarker of anti-oxidant defense
timeFrame: Baseline and 20 weeks
measure: Changes in biomarker of LV remodeling
timeFrame: Baseline and 20 weeks
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Leanne Groban, MD
role: PRINCIPAL_INVESTIGATOR
References: