Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency

Menopause Related Conditions Clinical Trial

— QUICKENED  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04258410
• Other study ID #: IRB-PENDING-LG
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 2022
• Est. completion date: January 2024

Study information

• Verified date: October 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause Related Conditions

Intervention

Drug:
• Placebo oral soft chew
placebo identical to experimental drug contained in soft chew
• Quercetin
experimental drug contained in soft chew

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in left ventricular systolic function	Measure left ventricular ejection fraction (LVEF) by transthoracic echocardiogram (TTE), pre and post intervention	Baseline and 20 weeks
Other	Changes in left ventricular diastolic function	Measures of myocardial relaxation by early septal mitral annular velocity (e') via tissue Doppler, and early-to-late transmitral filling velocity ratios (E/A) via Doppler from transthoracic echocardiogram, pre and post intervention	Baseline and 20 weeks
Other	Changes in left ventricular filling pressure	Calculate ratio of early transmitral filling (E)-to-mitral annular velocity (e'), or E/e', by Doppler-derived images from TTE, pre and post intervention	Baseline and 20 weeks
Other	Changes in left ventricular (LV) structure	Calculate LV mass and relative wall thickness from standard TTE images, pre and post intervention	Baseline and 20 weeks
Other	Changes in left atrial structure	Measure left atrial volume by TTE, pre and post intervention	Baseline and 20 weeks
Other	Changes in skeletal muscle quality	Echo-intensity, in pixels, of the vastus lateralis muscle of the thigh will be measured using ultrasound, pre and post intervention.	Baseline and 20 weeks
Other	Changes in skeletal muscle composition	Measure subcutaneous fat adjacent to vastus lateralis muscle by ultrasound, pre and post intervention	Baseline and 20 weeks
Other	Changes in exercise capacity	6-minute walk distance (6 MWD), pre and post intervention	Baseline and 20 weeks
Other	Changes in skeletal muscle strength	Five times sit-to-stand test, pre and post intervention	Baseline and 20 weeks
Other	Changes in biomarker of inflammation	Blood sample for measure of high-sensitivity C-reactive protein (hs-CRP), pre and post intervention	Baseline and 20 weeks
Other	Changes in biomarker of oxidative stress	Blood sample for determination of malondialdehyde by ELISA assay, pre and post intervention	Baseline and 20 weeks
Other	Changes in biomarker of anti-oxidant defense	Blood sample for glutathione levels using a commercial assay kit, pre and post intervention	Baseline and 20 weeks
Other	Changes in biomarker of LV remodeling	Blood sample for N terminal-ProBNP levels using the Roche Assay, pre and post intervention	Baseline and 20 weeks
Primary	Feasibility: Number of enrolled participants per month	Proportion of eligible participants enrolled each month, over the course of recruitment.	up through 13 months
Primary	Eligibility: Proportion eligible after screening	Proportion of eligible participants that are invited to participate after initial screening and reasons for declining enrollment.	baseline
Secondary	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.	20 weeks
Secondary	Adherence: Percent adherence to intervention	Participant treatment compliance will be determined by average plasma quercetin levels, in mg/dL, in each group.	20 weeks
Secondary	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.	20 weeks
Secondary	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.	20 weeks
Secondary	Acceptability: Changes in patient satisfaction	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.	Baseline and week 20