Modulation of Cerebral Blood Flow Using Quercetin, a Nutritional Supplement

Stroke Clinical Trial

— Quercetin  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376011
• Other study ID #: 1 K23AG030967-01A1-2
• Secondary ID: 1K23AG030967-01A
• Status: Completed
• Phase: Phase 0
• First received: June 16, 2011
• Last updated: January 26, 2015
• Start date: June 2009
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Problem of Aging
• Stroke

Intervention

Dietary Supplement:
• quercetin/placebo
Quercetin 500mg once per day versus placebo

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define change from baseline levels of HIF-1 concentration and 3 of its regulated proteins after 6 months of quercetin (versus placebo) dietary intake.	Baseline and 6 month blood samples will be analyzed for levels of HIF-1, VEGF, EPO, and NOS	6 months	No
Primary	Determine change from baseline brain blood flow after 6 months of quercetin (versus placebo) dietary intake.	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	No
Secondary	Define change from baseline performance in a battery of cognitive tasks after 6 months of quercetin (versus placebo) dietary intake.	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	No