Effects of Flavonoids on Cognitive Performance in Healthy Young Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeremy Paul Edward Spencer, University of Reading
ClinicalTrials.gov Identifier:
NCT01312597
First received: March 9, 2011
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Neurodegeneration
Other: Fruit juice beverage
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effects of Flavonoids on Cognitive Performance in Healthy Young Adults

Further study details as provided by University of Reading:

Primary Outcome Measures:
  • Executive function [ Time Frame: change in attention between baseline and 2h ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cerebral blood flow [ Time Frame: change in attention between baseline and 2h ] [ Designated as safety issue: No ]
    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


Enrollment: 30
Study Start Date: October 2010
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fruit beverage Other: Fruit juice 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 Other: Fruit juice beverage
500ml fruit juice beverage, single dose per visit
Other Names:
  • Tropicana Ruby Breakfast
  • Copella English Apple
  • Robinson's Lemon Barley Water

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312597

Locations
United Kingdom
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
  More Information

No publications provided

Responsible Party: Jeremy Paul Edward Spencer, Professor of Biochemistry, University of Reading
ClinicalTrials.gov Identifier: NCT01312597     History of Changes
Other Study ID Numbers: UReading-2011-01
Study First Received: March 9, 2011
Last Updated: November 22, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Reading:
Flavonoid
Cognitive performance
Cognitive function
Executive function
fMRI
Cerebral blood flow
Acute

Additional relevant MeSH terms:
Nerve Degeneration
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014