Effects of Flavonoids on Cognitive Performance in Healthy Young Adults

November 22, 2011 updated by: Jeremy Paul Edward Spencer, University of Reading
The purpose of this study is to investigate changes in cerebral blood flow, blood flavonoid levels, brain-derived neurotrophic factor, vascular reactivity and cognitive performance in young adults as a result of acute administration of a fruit-derived flavonoid-rich or flavonoid-poor drink.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There has recently been an increasing interest in the potential of flavonoids, plant derived compounds found in foods such as fruit and vegetables, to ameliorate age-related cognitive decline. Research suggests that flavonoids improve memory and learning, possibly as a result of their anti-oxidant, anti-inflammatory and neuroprotective effects for example by increasing cerebral blood flow, protecting vulnerable neurons, enhancing existing neuronal function or by stimulating neuronal function. The research will initially involve a randomised cross-over human dietary intervention trial using two flavonoid-rich drinks (flavanone-rich and flavanone-poor) to investigate changes in cerebral blood flow in young adults (n=6; age range 18-30 years). Changes in cognitive performance and measures of serum BDNF levels will then be investigated in a second randomised cross-over trial using the intervention drink showing the greatest effect on cerebral blood flow in young adults (n=24; age range 18-30 years) and using a range of sensitive tests of executive function. The study is designed to measure acute effects of types of flavonoid supplementation and, as well as the primary cognitive outcome, will assess flavonoid/metabolite and BDNF (brain-derived neurotrophic factor) levels in blood and changes in vascular reactivity.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 6AP
        • University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • MMSE between 26 and 30
  • 18-30 years of age
  • Native or good English speaker
  • Normal BMI/body fat composition
  • No significant vision, hearing or language problems
  • Able to consume the beverages

Exclusion Criteria:

  • Any form of disease/major mental illness/chronic fatigue syndrome
  • On medication for hypertension/elevated lipids/diabetes
  • On medication known to impact endothelial function
  • Gall bladder/gastrointestinal abnormalities
  • Sensitivity to orange or apple
  • High consumer of fruit, vegetables, fruit beverages
  • High consumer of caffeine or alcohol
  • Consumer of illegal substances
  • Vegetarian/vegan/other dieter/vigorous exerciser
  • Use of antibiotics in the previous 8 weeks
  • Consumer of dietary supplements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fruit beverage
500ml fruit juice beverage, single dose per visit
Other Names:
  • Tropicana Ruby Breakfast
  • Copella English Apple
  • Robinson's Lemon Barley Water
Experimental: Control beverage
500ml fruit juice beverage, single dose per visit
Other Names:
  • Tropicana Ruby Breakfast
  • Copella English Apple
  • Robinson's Lemon Barley Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Executive function
Time Frame: change in attention between baseline and 2h
45-minute computer-based test battery of executive function tasks administered twice per visit day, at 0 hours (baseline) and 2 hours post-intervention. Visit days are at least one week apart.
change in attention between baseline and 2h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral blood flow
Time Frame: change in attention between baseline and 2h
Non-invasive fMRI (arterial spin labelling) is conducted pre- and post-intervention at 3 time-points: 0 (baseline), and 2 and 5 hours post-intervention on 3 study days at least one week apart
change in attention between baseline and 2h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

March 9, 2011

First Submitted That Met QC Criteria

March 9, 2011

First Posted (Estimate)

March 10, 2011

Study Record Updates

Last Update Posted (Estimate)

November 23, 2011

Last Update Submitted That Met QC Criteria

November 22, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UReading-2011-01

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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