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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
placebo identical to experimental drug contained in soft chew
experimental drug contained in soft chew
Feasibility: Number of enrolled participants per month
Proportion of eligible participants enrolled each month, over the course of recruitment.
Time frame: 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.
Time frame: baseline
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.
Time frame: 20 weeks
Adherence: Percent adherence to intervention
Participant treatment compliance will be determined by average plasma quercetin levels, in mg/dL, in each group.
Time frame: 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.
Time frame: 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.
Time frame: 20 weeks
Acceptability: Changes in patient satisfaction
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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.
Time frame: Baseline and week 20