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Investigating the Acute Effects of Flavonoids in Blueberries on Cognitive Function.

Sponsor
University of Reading (Other)
Overall Status
Completed
CT.gov ID
NCT01289860
Collaborator
(none)
47
Enrollment
1
Location
2
Arms
44.1
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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
  • Dietary Supplement: Flavonoids
  • Dietary Supplement: Control
 N/A

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 Design

Study Type:
Interventional
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 1, 2009
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Blueberry drink

30g of blueberry powder (equivalent to 200g fresh blueberries) and 300ml of semi-skimmed milk

Dietary Supplement: Flavonoids
475g of anthocyanidins in 300ml of blueberry drink.
Other Names:
  • 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.

    Dietary Supplement: Control
    29g powder: sugars (glucose, sucrose, fructose), vitamin C and citric acid.

    Outcome Measures

    Primary Outcome Measures

    1. Cognitive function [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.

    Secondary Outcome Measures

    1. Bioavailability and pharmacology [Pre drink and 1 hour post drink]

      Flavonoid and BDNF levels in plasma and urine samples.

    2. Vascular Reactivity [Pre and 1 hour post drink]

      Measurements taken using Digital volume pulse equipment. Blood pressure also recorded.

    3. Neuronal effects [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Reading Reading Berkshire United Kingdom RG6 6AP

    Sponsors and Collaborators

    • University of Reading

    Investigators

    • Principal Investigator: Jeremy PE Spencer, PhD, University of Reading
    • Principal Investigator: Laurie T Butler, PhD, University of Reading

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Feb 4, 2011
    Last Update Posted:
    Feb 21, 2013
    Last Verified:
    Feb 1, 2013

    Study Results

    No Results Posted as of Feb 21, 2013