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Clinical Trials/NCT01289860
NCT01289860CompletedNot Applicable

A Controlled, Cross-over, Acute Intervention Study Investigating the Cognitive and Neuronal Effects of Flavonoids in Blueberries.

University of Reading2 sites in 1 country47 target enrollmentStarted: May 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
47
Locations
2
Primary Endpoint
Cognitive function

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Bioavailability and pharmacology(Pre drink and 1 hour post drink)
  • Vascular Reactivity(Pre and 1 hour post drink)
  • Neuronal effects(Pre and 1 hours post drink)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeremy Paul Edward Spencer

Professor of Nutritional Medicine

University of Reading

Study Sites (2)

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