Modulation of Cerebral Blood Flow Using Quercetin, a Nutritional Supplement

Early Phase 1

Completed

• Conditions: Stroke; Problem of Aging
• Interventions: Dietary Supplement: quercetin/placebo

• Registration Number: NCT01376011
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-20
• Primary Completion: 2012-06
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy young	quercetin/placebo	-
healthy old	quercetin/placebo	-

Primary Outcome Measures

Name	Time	Method
Define change from baseline levels of HIF-1 concentration and 3 of its regulated proteins after 6 months of quercetin (versus placebo) dietary intake.	6 months	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.	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

Name	Time	Method
Define change from baseline performance in a battery of cognitive tasks after 6 months of quercetin (versus placebo) dietary intake.	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States