- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01289860
Investigating the Acute Effects of Flavonoids in Blueberries on Cognitive Function.
A Controlled, Cross-over, Acute Intervention Study Investigating the Cognitive and Neuronal Effects of Flavonoids in Blueberries.
This study was a controlled, cross-over, acute flavonoid intervention trial with younger and older adults. Subjects consumed a blueberry beverage during one visit and a control beverage on another. Cognitive function pre drink was assessed, blood and urine samples were taken as well as blood pressure and a measure of vascular reactivity. These outcome measures were taken at 2 and 5 hours post drink.
It was predicted that the flavonoids in the blueberry drink would lead to improved performance on the cognitive tests and vascular reactivity measure compared to following the control drink. It was thought this could be due to increased vaso-dilation and improving blood flow to the brain which was investigated in an extension to the project where a sample of individuals underwent brain imaging in an MRI scanner pre and post a blueberry and a control drink.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The control drink was matched to the blueberry drink for other bioactive compounds which may have affected cognition, specifically sugars and vitamin C. Volunteers were healthy, not on any medication, without high blood pressure, high cholesterol, high BMI, diabetes or other medical conditions. Older adults were aged 61-75 years and younger adults 18-26 years.
Blood and urine samples will be analysed for flavonoid levels and Brain Derived Neurotrophic Factor, a biomarker of memory and learning, flavonoids may lead to increased BDNF production through the ERK-CREB-BDNF pathway.
Flavonoids may also increase nitric oxide production and improve the flexibility of the blood vessels hence the measure of vascular reactivity using the Digital Volume Pulse machine. This can lead to increased vaso-dilation and blood flow to the brain, therefore an fMRI study was carried out the investigate this using arterial spin labeling following acute blueberry supplementation compared to a control drink.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Berkshire
-
Reading, Berkshire, United Kingdom, RG6 6AP
- University of Reading
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- No medical conditions
- Not taking any medication or supplements (or willing to stop taking supplements for duration of study)
- Not lactose intolerant
- Willing to give blood and urine samples
- Not partaking in frequent vigorous exercise
- Not suffering from or history of depression
Exclusion Criteria:
- On blood pressure medication, taking Aspirin or other blood thinning medication
- BMI > 30
- Cholesterol > 6
- Diabetes or other serious medical condition
- Lactose intolerant
- Any learning difficulty e.g. dyslexia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Blueberry drink
30g of blueberry powder (equivalent to 200g fresh blueberries) and 300ml of semi-skimmed milk
|
475g of anthocyanidins in 300ml of blueberry drink.
Other Names:
|
Placebo Comparator: Control drink
29g of powder consisting of sugars and vitamin C, values of which were matched to that of the blueberry drink, with 1 g of citric acid to match for taste.
|
29g powder: sugars (glucose, sucrose, fructose), vitamin C and citric acid.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function
Time Frame: pre drink, 2 hours and 5 hours post drink
|
Extensive cognitive test battery including tasks measuring executive function such as updating, and memory tests such as free recall.
|
pre drink, 2 hours and 5 hours post drink
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bioavailability and pharmacology
Time Frame: Pre drink and 1 hour post drink
|
Flavonoid and BDNF levels in plasma and urine samples.
|
Pre drink and 1 hour post drink
|
Vascular Reactivity
Time Frame: Pre and 1 hour post drink
|
Measurements taken using Digital volume pulse equipment.
Blood pressure also recorded.
|
Pre and 1 hour post drink
|
Neuronal effects
Time Frame: Pre and 1 hours post drink
|
Using fMRI to determine whether flavonoid supplementation leads to greater activation in brain regions associated with the cognitive abilities tested and to calculate cerebral blood flow before and after the blueberry compared to the control drink.
|
Pre and 1 hours post drink
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laurie T Butler, PhD, University of Reading
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UReading_2010_01
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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