Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency

NCT04258410 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: IRB-PENDING-LG
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Menopause Related Conditions

Keywords

estrogen deficiency; post-menopause; cardiac diastolic function; skeletal muscle function; skeletal muscle structure; cardiac structure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Adherence: Percent adherence to study visits

  20 weeks

• Adherence: Percent adherence to intervention

  20 weeks

• Retention: Number of Subjects Lost to Follow Up

  20 weeks

• Retention: Number of Subjects Discontinued

  20 weeks

• Acceptability: Changes in patient satisfaction

  Baseline and week 20

Other Outcomes (13)

• Changes in left ventricular systolic function

  Baseline and 20 weeks

• Changes in left ventricular diastolic function

  Baseline and 20 weeks

• Changes in left ventricular filling pressure

  Baseline and 20 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral soft chew

Active Drug

EXPERIMENTAL

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

Interventions

Placebo oral soft chew DRUG

placebo identical to experimental drug contained in soft chew

Placebo

Quercetin DRUG

experimental drug contained in soft chew

Also known as: Bioflavonoid

Active Drug

Eligibility Criteria

• Age: 60 Years - 74 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Interventions

Quercetin; Flavonoids

Intervention Hierarchy (Ancestors)

Flavonols; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Leanne Groban, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Enrolled participants who complete the pre-treatment assessment will be randomly assigned to Quercetin or placebo. The trial manager who is not involved in any outcome assessments will carry out randomization following the protocol designed by the study biostatistician (Dr. Leng) prior to the study's start. The randomization sequence list will remain concealed from the investigators. Participants will be randomized using a computer-generated, password-protected randomization list, and simple randomization scheme. All staff involved in data collection and management will be kept unaware of the participants' group assignments and will explicitly inform participants that they (staff) are to remain blinded during the course of the study. The biostatistician will also be unaware of treatment assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind randomized controlled parallel pilot trial of Quercetin vs placebo oral administration in 24 postmenopausal women.

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share