Cognitive and Cerebral Blood Flow Effects of ResveratrolNCT01010009
The Cognitive and Cerebral Blood Flow Effects of Resveratrol
A study testing Trans- resveratrol in people with Cognitive and Cerebral Blood Flow Effects of Resveratrol, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Research shows that resveratrol is able to induce vasodilation (and therefore blood flow) by interacting with nitric oxide (NO). Research also shows that acute administration of metabolic substrates, like oxygen and glucose, can enhance aspects of cognitive performance in young, healthy humans. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive and Cerebral Blood Flow Effects of Resveratrol
- What is being tested?
- Trans- resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male/female,
- Healthy
- Age 18-35 years old
- Non smoker
- Proficient in English
- Not taking any herbal or prescription medications
- Not pregnant
- Does not drink more than 6 cups of coffee per day
Who cannot join
- Suffered a head injury, neurological disorder or neuro-developmental disorder
- Food allergies/intolerances
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
Official title: Effects of Resveratrol on Cerebral Blood Flow Parameters and Cognitive Performance in Humans: a Double-blind, Placebo-controlled, Crossover Investigation
Research shows that resveratrol is able to induce vasodilation (and therefore blood flow) by interacting with nitric oxide (NO). Research also shows that acute administration of metabolic substrates, like oxygen and glucose, can enhance aspects of cognitive performance in young, healthy humans. The aim of this investigation was to determine if the consumption of resveratrol could modulate cerebral blood flow and if this in turn could influence cognitive performance by increasing access to blood borne metabolic fuel. Results showed that compared to placebo, after consuming 500mg pure trans-resveratrol, levels of total haemoglobin were significantly higher in the frontal cortex of young, healthy participants during cognitive task completion. Cognitive performance was not effected.
- Being tested
- Trans- resveratrol, Placebo (silica)
- Keywords
- resveratrol, cerebral blood flow, NIRS, cognitive performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans- resveratrolDietary supplement
Also called Transmax from Biotivia.
All 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner.
Placebo (silica)Other
Also called Pharmaceutical grade silica
All 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner.
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol 250mg | Experimental | Not described Receives: Dietary Supplement: Trans- resveratrol; Other: Placebo (silica) |
| Resveratrol 500mg | Experimental | Not described Receives: Dietary Supplement: Trans- resveratrol; Other: Placebo (silica) |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Trans- resveratrol; Other: Placebo (silica) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulation of Levels of Total Haemoglobin
This outcome measure provides the change from baseline values (in µmol/L) of total levels of haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).
Measured: 0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)
Modulation of Deoxygenated Levels of Haemoglobin
This outcome measure provides the change from baseline values (in µmol/L) of levels of deoxygenated haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).
Measured: 0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)
Secondary outcomes (1)
Number of Participants With Significant Modulation of Cognitive Performance
This outcome measure assessed any significant modulation of cognitive task performance during the 46-81 min post dose period. The cognitive tasks utilized were cognitively demanding computer based, numerical tasks which assessed working memory. Significant modulation is defined as significant difference between baseline and post-dose task performance.
Measured: 46-81 mins post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startJun 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognitive and Cerebral Blood Flow Effects of ResveratrolStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Investigators
- Crystal Haskell, Study director, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010009
- Sponsor's protocol ID
- 22P2
- Status last verified
- May 2012
- First submitted
- 6 Nov 2009
- Last updated
- 23 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resveratrol on Cerebral Blood Flow Parameters and Cognitive Performance in Humans: a Double-blind, Placebo-controlled, Crossover Investigation
- ClinicalTrials.gov ID
- NCT01010009
- Acronym / sponsor ID
- 22P2
- Keywords
- resveratrol, cerebral blood flow, NIRS, cognitive performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 9 Nov 2009 (estimated)
- Results
- Posted 18 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research shows that resveratrol is able to induce vasodilation (and therefore blood flow) by interacting with nitric oxide (NO). Research also shows that acute administration of metabolic substrates, like oxygen and glucose, can enhance aspects of cognitive performance in young, healthy humans. The aim of this investigation was to determine if the consumption of resveratrol could modulate cerebral blood flow and if this in turn could influence cognitive performance by increasing access to blood borne metabolic fuel. Results showed that compared to placebo, after consuming 500mg pure trans-resveratrol, levels of total haemoglobin were significantly higher in the frontal cortex of young, healthy participants during cognitive task completion. Cognitive performance was not effected.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resveratrol 250mg | Experimental | Dietary Supplement: Trans- resveratrol, Other: Placebo (silica) |
| Resveratrol 500mg | Experimental | Dietary Supplement: Trans- resveratrol, Other: Placebo (silica) |
| Placebo | Placebo comparator | Dietary Supplement: Trans- resveratrol, Other: Placebo (silica) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male/female,
- Healthy
- Age 18-35 years old
- Non smoker
- Proficient in English
Key exclusion criteria (2 listed)
- Suffered a head injury, neurological disorder or neuro-developmental disorder
- Food allergies/intolerances
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 |
|---|---|---|
| Trans- resveratrolAlso: Transmax from Biotivia.All 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner. | Dietary supplement | Placebo, Resveratrol 250mg, Resveratrol 500mg |
| Placebo (silica)Also: Pharmaceutical grade silicaAll 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner. | Other | Placebo, Resveratrol 250mg, Resveratrol 500mg |
Primary outcome
Modulation of Levels of Total Haemoglobin
Time frame: 0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)
This outcome measure provides the change from baseline values (in µmol/L) of total levels of haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).
Modulation of Deoxygenated Levels of Haemoglobin
Time frame: 0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)
This outcome measure provides the change from baseline values (in µmol/L) of levels of deoxygenated haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).
1 secondary outcome
Number of Participants With Significant Modulation of Cognitive Performance
Time frame: 46-81 mins post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Crystal Haskell study director
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans- resveratrol in people with Cognitive and Cerebral Blood Flow Effects of Resveratrol, run by Northumbria University at 1 site in United Kingdom.
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 8 inclusion and 2 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 23 May 2012. 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 Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Modulation of Levels of Total Haemoglobin (time frame: 0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)). 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 23 May 2012.