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

NCT04258410 Phase 4 WITHDRAWN

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).

Details

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 4
Status	WITHDRAWN
Start date	2022-09
Completion	2024-01

Conditions

• Menopause Related Conditions

Interventions

• Placebo oral soft chew
• Quercetin

Primary outcomes

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