NCT04258410

Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 60 Years – 74 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Placebo oral soft chew	placebo identical to experimental drug contained in soft chew
DRUG	Quercetin	experimental drug contained in soft chew

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-12-01
• Completion: 2024-01-01
• First posted: 2020-02-06
• Last updated: 2022-10-10

Regulatory

• FDA-regulated drug study