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Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency (QUICKENED)

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ClinicalTrials.gov Identifier: NCT04258410
Recruitment Status : Suspended (Investigator is revising protocol.)
First Posted : February 6, 2020
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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).

Condition or disease Intervention/treatment Phase
Menopause Related Conditions Drug: Placebo oral soft chew Drug: Quercetin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized controlled parallel pilot trial of Quercetin vs placebo oral administration in 24 postmenopausal women.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency (QUICKENED) Feasibility Study in Older Women
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
Drug Information available for: Quercetin

Arm Intervention/treatment
Placebo Comparator: Placebo
Blinded subjects in this arm will receive 2 placebo (blank) soft chews, twice daily, orally for 20 weeks.
Drug: Placebo oral soft chew
placebo identical to experimental drug contained in soft chew

Experimental: 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.
Drug: Quercetin
experimental drug contained in soft chew
Other Name: Bioflavonoid




Primary Outcome Measures :
  1. Feasibility: Number of enrolled participants per month [ Time Frame: up through 13 months ]
    Proportion of eligible participants enrolled each month, over the course of recruitment.

  2. Eligibility: Proportion eligible after screening [ Time Frame: baseline ]
    Proportion of eligible participants that are invited to participate after initial screening and reasons for declining enrollment.


Secondary Outcome Measures :
  1. Adherence: Percent adherence to study visits [ Time Frame: 20 weeks ]
    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.

  2. Adherence: Percent adherence to intervention [ Time Frame: 20 weeks ]
    Participant treatment compliance will be determined by average plasma quercetin levels, in mg/dL, in each group.

  3. Retention: Number of Subjects Lost to Follow Up [ Time Frame: 20 weeks ]
    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.

  4. Retention: Number of Subjects Discontinued [ Time Frame: 20 weeks ]
    Participants that are prematurely terminated or discontinued from the study will be quantified. The circumstances that may warrant discontinuation will be evaluated and recorded.

  5. Acceptability: Changes in patient satisfaction [ Time Frame: Baseline and week 20 ]
    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.


Other Outcome Measures:
  1. Changes in left ventricular systolic function [ Time Frame: Baseline and 20 weeks ]
    Measure left ventricular ejection fraction (LVEF) by transthoracic echocardiogram (TTE), pre and post intervention

  2. Changes in left ventricular diastolic function [ Time Frame: Baseline and 20 weeks ]
    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

  3. Changes in left ventricular filling pressure [ Time Frame: Baseline and 20 weeks ]
    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

  4. Changes in left ventricular (LV) structure [ Time Frame: Baseline and 20 weeks ]
    Calculate LV mass and relative wall thickness from standard TTE images, pre and post intervention

  5. Changes in left atrial structure [ Time Frame: Baseline and 20 weeks ]
    Measure left atrial volume by TTE, pre and post intervention

  6. Changes in skeletal muscle quality [ Time Frame: Baseline and 20 weeks ]
    Echo-intensity, in pixels, of the vastus lateralis muscle of the thigh will be measured using ultrasound, pre and post intervention.

  7. Changes in skeletal muscle composition [ Time Frame: Baseline and 20 weeks ]
    Measure subcutaneous fat adjacent to vastus lateralis muscle by ultrasound, pre and post intervention

  8. Changes in exercise capacity [ Time Frame: Baseline and 20 weeks ]
    6-minute walk distance (6 MWD), pre and post intervention

  9. Changes in skeletal muscle strength [ Time Frame: Baseline and 20 weeks ]
    Five times sit-to-stand test, pre and post intervention

  10. Changes in biomarker of inflammation [ Time Frame: Baseline and 20 weeks ]
    Blood sample for measure of high-sensitivity C-reactive protein (hs-CRP), pre and post intervention

  11. Changes in biomarker of oxidative stress [ Time Frame: Baseline and 20 weeks ]
    Blood sample for determination of malondialdehyde by ELISA assay, pre and post intervention

  12. Changes in biomarker of anti-oxidant defense [ Time Frame: Baseline and 20 weeks ]
    Blood sample for glutathione levels using a commercial assay kit, pre and post intervention

  13. Changes in biomarker of LV remodeling [ Time Frame: Baseline and 20 weeks ]
    Blood sample for N terminal-ProBNP levels using the Roche Assay, pre and post intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258410


Locations
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United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Leanne Groban, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04258410    
Other Study ID Numbers: IRB-PENDING-LG
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wake Forest University Health Sciences:
estrogen deficiency
post-menopause
cardiac diastolic function
skeletal muscle function
skeletal muscle structure
cardiac structure
Additional relevant MeSH terms:
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Quercetin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs