StrokeEarly Phase 1QuercetinNCT01376011
Modulation of Cerebral Blood Flow Using Quercetin, a Nutritional Supplement
A Early Phase 1 study of Stroke and Problem of Aging, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Problem of Aging
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers between the ages of 18-75 years old
Who cannot join
- subjects taking vasoactive medications
- hypertension or vascular disease
- asthma
- smokers
- pregnant women
- cancer
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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.
- Conditions
- Stroke, Problem of Aging
- Being tested
- quercetin/placebo
- Keywords
- quercetin, brain blood flow, aging, memory
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quercetin/placeboDietary supplement
Quercetin 500mg once per day versus placebo
| Study group | Role | What they receive |
|---|---|---|
| healthy young | Experimental | Not described Receives: Dietary Supplement: quercetin/placebo |
| healthy old | Experimental | Not described Receives: Dietary Supplement: quercetin/placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Assess effects of 6 months of quercetin intake on cognitive function using a cognitive battery designed to asses both memory and executive function.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startJun 2009
- Primary completionJun 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Farzaneh Sorond, Brigham and Women's Hospital
- Investigators
- Farzaneh Sorond, mD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376011
- Sponsor's protocol ID
- 1 K23AG030967-01A1-2
- Other IDs
- 1K23AG030967-01A1
- Acronym
- Quercetin
- Status last verified
- Jan 2015
- First submitted
- 16 Jun 2011
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxia-inducible Transcription Factor 1 (HIF-1) in Vascular Aging
- ClinicalTrials.gov ID
- NCT01376011
- Acronym / sponsor ID
- Quercetin / 1 K23AG030967-01A1-2
- Conditions
- Stroke, Problem of Aging
- Keywords
- quercetin, brain blood flow, aging, memory
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jun 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy young | Experimental | Dietary Supplement: quercetin/placebo |
| healthy old | Experimental | Dietary Supplement: quercetin/placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers between the ages of 18-75 years old
Key exclusion criteria (11 listed)
- subjects taking vasoactive medications
- hypertension or vascular disease
- asthma
- smokers
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quercetin/placeboQuercetin 500mg once per day versus placebo | Dietary supplement | healthy old, healthy young |
Primary outcome
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
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.
1 secondary outcome
Define change from baseline performance in a battery of cognitive tasks after 6 months of quercetin (versus placebo) dietary intake.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farzaneh Sorond, mD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study of Stroke and Problem of Aging, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015.