Clinical trial NCT01289860: Investigating the Acute Effects of Flavonoids in Blueberries on Cognitive Function.
Official title: A Controlled, Cross-over, Acute Intervention Study Investigating the Cognitive and Neuronal Effects of Flavonoids in Blueberries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults.
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2011-02-04
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive function
timeFrame: pre drink, 2 hours and 5 hours post drink
Secondary outcomes:
measure: Bioavailability and pharmacology
timeFrame: Pre drink and 1 hour post drink
measure: Vascular Reactivity
timeFrame: Pre and 1 hour post drink
measure: Neuronal effects
timeFrame: Pre and 1 hours post drink
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Jeremy PE Spencer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Reading
name: Laurie T Butler, PhD
role: PRINCIPAL_INVESTIGATOR
References: