Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Modulation of Cerebral Blood Flow Using Quercetin, a Nutritional Supplement

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Farzaneh Sorond, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01376011
First received: June 16, 2011
Last updated: January 26, 2015
Last verified: January 2015

June 16, 2011
January 26, 2015
June 2009
June 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01376011 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Modulation of Cerebral Blood Flow Using Quercetin, a Nutritional Supplement
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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Stroke
  • Problem of Aging
Dietary Supplement: quercetin/placebo
Quercetin 500mg once per day versus placebo
  • Experimental: healthy young
    Intervention: Dietary Supplement: quercetin/placebo
  • Experimental: healthy old
    Intervention: Dietary Supplement: quercetin/placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
December 2014
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01376011
1 K23AG030967-01A1-2, 1K23AG030967-01A1
Yes
Farzaneh Sorond, Brigham and Women's Hospital
Brigham and Women's Hospital
National Institute on Aging (NIA)
Principal Investigator: Farzaneh Sorond, mD, PhD Brigham and Women's Hospital
Brigham and Women's Hospital
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP