Modulation of Cerebral Blood Flow Using Quercetin, a Nutritional Supplement (Quercetin)

January 26, 2015 updated by: Farzaneh Sorond, Brigham and Women's Hospital

Hypoxia-inducible Transcription Factor 1 (HIF-1) in Vascular Aging

The purpose of this study is to find out if quercetin can increase blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a corresponding increase in blood flow to the brain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteers between the ages of 18-75 years old

Exclusion Criteria:

  • subjects taking vasoactive medications
  • hypertension or vascular disease
  • asthma
  • smokers
  • pregnant women
  • cancer
  • diabetes mellitus
  • history of seizures
  • history of stroke or head trauma
  • subjects taking digoxin, cyclosporine,felodipine, estradiol, or quinolone antibiotics
  • poor transcranial Doppler insonation windows

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: healthy young
Dietary supplement: quercetin/placebo
Quercetin 500mg once per day versus placebo
Experimental: healthy old
Dietary supplement: quercetin/placebo
Quercetin 500mg once per day versus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Define change from baseline levels of HIF-1 concentration and 3 of its regulated proteins after 6 months of quercetin (versus placebo) dietary intake.
Time Frame: 6 months
Baseline and 6 month blood samples will be analyzed for levels of HIF-1, VEGF, EPO, and NOS
6 months
Determine change from baseline brain blood flow after 6 months of quercetin (versus placebo) dietary intake.
Time Frame: 6 months
Determine cerebral vasomotor reactivity response to 6 months of quercetin intake by measuring changes in middle cerebral artery (MCA) blood flow velocity in response to changes in end-tidal CO2, and assess neurovascular coupling by measuring changes in MCA flow velocity in response to neuropsychological tasks.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Define change from baseline performance in a battery of cognitive tasks after 6 months of quercetin (versus placebo) dietary intake.
Time Frame: 6 months
Assess effects of 6 months of quercetin intake on cognitive function using a cognitive battery designed to asses both memory and executive function.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Farzaneh Sorond, mD, PhD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria

June 17, 2011

First Posted (Estimate)

June 20, 2011

Study Record Updates

Last Update Posted (Estimate)

January 28, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 K23AG030967-01A1-2
  • 1K23AG030967-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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