Modulation of Cerebral Blood Flow Using Quercetin, a Nutritional Supplement

NCT01376011 | Completed Early Phase 1 DMC

• 2 other identifiers: 1 K23AG030967-01A1-21K23AG030967-01A1
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Problem of Aging

Keywords

quercetin; brain blood flow; aging; memory

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

healthy young

EXPERIMENTAL

Dietary Supplement: quercetin/placebo

healthy old

EXPERIMENTAL

Dietary Supplement: quercetin/placebo

Interventions

quercetin/placebo DIETARY_SUPPLEMENT

Quercetin 500mg once per day versus placebo

healthy old; healthy young

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers between the ages of 18-75 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Quercetin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Farzaneh Sorond, mD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 20, 2011
• Study Start: June 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2014
• Last Updated: January 28, 2015

Record last verified: 2015-01

Locations

US (1)