Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency

NCT ID: NCT04258410

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2024-01-31

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.

Conditions

Menopause Related Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Blinded subjects in this arm will receive 2 placebo (blank) soft chews, twice daily, orally for 20 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo oral soft chew

Intervention Type: DRUG

placebo identical to experimental drug contained in soft chew

Active Drug

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.

Group Type: EXPERIMENTAL

Quercetin

Intervention Type: DRUG

experimental drug contained in soft chew

Interventions

Placebo oral soft chew

placebo identical to experimental drug contained in soft chew

Intervention Type: DRUG

Quercetin

experimental drug contained in soft chew

Intervention Type: DRUG

Other Intervention Names

Bioflavonoid

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leanne Groban, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Other Identifiers

IRB-PENDING-LG

Identifier Type: -

Identifier Source: org_study_id