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Menopause Related ConditionsPhase 4QUICKENEDNCT04258410

Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency

A Phase 4 study testing Quercetin in people with Menopause Related Conditions, run by Wake Forest University Health Sciences.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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… Read more about this study

Who is it for?
Ages 60 to 74 years, women only
Conditions the study is for
Menopause Related Conditions
What is being tested?
Quercetin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2022to Jan 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 74 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

About this study

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

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).

Read the 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.

Being tested
Placebo oral soft chew, Quercetin
Keywords
estrogen deficiency, post-menopause, cardiac diastolic function, skeletal muscle function, skeletal muscle structure, cardiac structure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo oral soft chewDrug

    placebo identical to experimental drug contained in soft chew

  • QuercetinDrug

    Also called Bioflavonoid

    experimental drug contained in soft chew

Study groups in NCT04258410
Study groupRoleWhat they receive
PlaceboPlacebo comparatorBlinded subjects in this arm will receive 2 placebo (blank) soft chews, twice daily, orally for 20 weeks.
Receives: Drug: Placebo oral soft chew
Active DrugExperimentalBlinded 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.
Receives: Drug: Quercetin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility: Number of enrolled participants per month

    Proportion of eligible participants enrolled each month, over the course of recruitment.

    Measured: up through 13 months

  2. Eligibility: Proportion eligible after screening

    Proportion of eligible participants that are invited to participate after initial screening and reasons for declining enrollment.

    Measured: baseline

Secondary outcomes (5)

  1. 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.

    Measured: 20 weeks

  2. Adherence: Percent adherence to intervention

    Participant treatment compliance will be determined by average plasma quercetin levels, in mg/dL, in each group.

    Measured: 20 weeks

  3. 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.

    Measured: 20 weeks

  4. 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.

    Measured: 20 weeks

  5. 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.

    Measured: Baseline and week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2020
  2. Study startSep 2022 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionJan 2024 (estimated)

Why it stopped: Per PI: "Never went to IRB Never recruited anyone Never resubmitted the score NIH application I am leaving the institution"

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blind randomized controlled parallel pilot trial of Quercetin vs placebo oral administration in 24 postmenopausal women.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04258410
Sponsor's protocol ID
IRB-PENDING-LG
Acronym
QUICKENED
Status last verified
Oct 2022
First submitted
4 Feb 2020
Last updated
10 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Quercetin in people with Menopause Related Conditions, run by Wake Forest University Health Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Number of enrolled participants per month (time frame: up through 13 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04258410.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.

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