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OpenTrials
Completed

NCT Number: NCT01376011

Modulation of Cerebral Blood Flow Using Quercetin, a Nutritional Supplement

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Problem of Aging Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

quercetin/placebo

Dietary Supplement

Quercetin 500mg once per day versus placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: Quercetin

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Jun 20, 2011
Registry last updated
Jan 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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