- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01010009
The Cognitive and Cerebral Blood Flow Effects of Resveratrol
May 17, 2012 updated by: Northumbria University
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Newcastle upon Tyne, United Kingdom, NE1 8ST
- Northumbria University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Suffered a head injury, neurological disorder or neuro-developmental disorder
- Food allergies/intolerances
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
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.
Other Names:
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.
Other Names:
|
Experimental: Resveratrol 250mg
|
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.
Other Names:
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.
Other Names:
|
Experimental: Resveratrol 500mg
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)
|
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).
|
0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Significant Modulation of Cognitive Performance
Time Frame: 46-81 mins post dose
|
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.
|
46-81 mins post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
November 6, 2009
First Submitted That Met QC Criteria
November 6, 2009
First Posted (Estimate)
November 9, 2009
Study Record Updates
Last Update Posted (Estimate)
May 23, 2012
Last Update Submitted That Met QC Criteria
May 17, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22P2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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