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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01376011
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : January 28, 2015
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Farzaneh Sorond, Brigham and Women's Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Problem of Aging Dietary Supplement: quercetin/placebo Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hypoxia-inducible Transcription Factor 1 (HIF-1) in Vascular Aging
Study Start Date : June 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Quercetin

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT01376011


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Farzaneh Sorond, mD, PhD Brigham and Women's Hospital
More Information
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Responsible Party: Farzaneh Sorond, Principle Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01376011    
Other Study ID Numbers: 1 K23AG030967-01A1-2
1K23AG030967-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015
Keywords provided by Farzaneh Sorond, Brigham and Women's Hospital:
quercetin
brain blood flow
aging
memory
Additional relevant MeSH terms:
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Quercetin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs