Investigating the Acute Effects of Flavonoids in Blueberries on Cognitive Function.
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ClinicalTrials.gov Identifier: NCT01289860 |
Recruitment Status :
Completed
First Posted : February 4, 2011
Last Update Posted : February 21, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
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Healthy Adults. | Dietary Supplement: Flavonoids Dietary Supplement: Control | Not Applicable |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Basic Science |
Official Title: | A Controlled, Cross-over, Acute Intervention Study Investigating the Cognitive and Neuronal Effects of Flavonoids in Blueberries. |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2013 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Blueberry drink
30g of blueberry powder (equivalent to 200g fresh blueberries) and 300ml of semi-skimmed milk
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Dietary Supplement: Flavonoids
475g of anthocyanidins in 300ml of blueberry drink.
Other Name: Anthocyanidins, flavanols, flavonols. |
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.
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Dietary Supplement: Control
29g powder: sugars (glucose, sucrose, fructose), vitamin C and citric acid. |
- 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.
- Bioavailability and pharmacology [ Time Frame: Pre drink and 1 hour post drink ]Flavonoid and BDNF levels in plasma and urine samples.
- Vascular Reactivity [ Time Frame: Pre and 1 hour post drink ]Measurements taken using Digital volume pulse equipment. Blood pressure also recorded.
- 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.
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289860
United Kingdom | |
University of Reading | |
Reading, Berkshire, United Kingdom, RG6 6AP |
Principal Investigator: | Jeremy PE Spencer, PhD | University of Reading | |
Principal Investigator: | Laurie T Butler, PhD | University of Reading |
Responsible Party: | Jeremy Paul Edward Spencer, Professor of Nutritional Medicine, University of Reading |
ClinicalTrials.gov Identifier: | NCT01289860 |
Other Study ID Numbers: |
UReading_2010_01 |
First Posted: | February 4, 2011 Key Record Dates |
Last Update Posted: | February 21, 2013 |
Last Verified: | February 2013 |