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Modulation of Cerebral Blood Flow Using Quercetin, a Nutritional Supplement

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Farzaneh Sorond, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01376011
First received: June 16, 2011
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Stroke
Problem of Aging
 Dietary Supplement: quercetin/placebo
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hypoxia-inducible Transcription Factor 1 (HIF-1) in Vascular Aging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Baseline and 6 month blood samples will be analyzed for levels of HIF-1, VEGF, EPO, and NOS

  • Determine change from baseline brain blood flow after 6 months of quercetin (versus placebo) dietary intake. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Define change from baseline performance in a battery of cognitive tasks after 6 months of quercetin (versus placebo) dietary intake. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assess effects of 6 months of quercetin intake on cognitive function using a cognitive battery designed to asses both memory and executive function.


Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376011

Locations
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
Principal Investigator: Farzaneh Sorond, mD, PhD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Farzaneh Sorond, Principle Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01376011     History of Changes
Other Study ID Numbers: 1 K23AG030967-01A1-2, 1K23AG030967-01A1
Study First Received: June 16, 2011
Last Updated: February 14, 2013
Health Authority: United States: Data Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
quercetin
brain blood flow
aging
memory

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Quercetin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013