Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency

Study Overview
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Brief Summary
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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
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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.

Official Title
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Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency (QUICKENED) Feasibility Study in Older Women

Conditions
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Menopause Related Conditions

Intervention / Treatment
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* Drug: Placebo oral soft chew
* Drug: Quercetin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind randomized controlled parallel pilot trial of Quercetin vs placebo oral administration in 24 postmenopausal women.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Blinded subjects in this arm will receive 2 placebo (blank) soft chews, twice daily, orally for 20 weeks. | Drug: Placebo oral soft chew<br>* placebo identical to experimental drug contained in soft chew<br>|
| Experimental: Active Drug<br>Blinded subjects in this arm will receive 1 g/day of Quercetin delivered in 2 soft chews (250 mg/chew), twice daily, orally, for 20 weeks. | Drug: Quercetin<br>* experimental drug contained in soft chew<br>* Other names: Bioflavonoid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Number of enrolled participants per month | Proportion of eligible participants enrolled each month, over the course of recruitment. | up through 13 months | 
| Eligibility: Proportion eligible after screening | Proportion of eligible participants that are invited to participate after initial screening and reasons for declining enrollment. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence: Percent adherence to study visits | Missing data will be quantified, and reasons for failure to follow-up will be determined through informal comments from participants, via phone contact, to assess adherence barriers. | 20 weeks | 
| Adherence: Percent adherence to intervention | Participant treatment compliance will be determined by average plasma quercetin levels, in mg/dL, in each group. | 20 weeks | 
| Retention: Number of Subjects Lost to Follow Up | Missing data and drop-out will be quantified, and reasons for lost to follow up will be evaluated through informal comments from participants and Likert-ranked questions to assess participant perceptions of strengths and weaknesses of the study. | 20 weeks | 
| Retention: Number of Subjects Discontinued | Participants that are prematurely terminated or discontinued from the study will be quantified. The circumstances that may warrant discontinuation will be evaluated and recorded. | 20 weeks | 
| Acceptability: Changes in patient satisfaction | Likert-ranking to assess participant perceptions of the strengths and weaknesses of the study. Scores range from 1 to 5 with a higher score denoting a positive outcome. | Baseline and week 20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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estrogen deficiency, post-menopause, cardiac diastolic function, skeletal muscle function, skeletal muscle structure, cardiac structure