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Completed

NCT Number: NCT01312597

Effects of Flavonoids on Cognitive Performance in Healthy Young Adults

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.

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Key information

Conditions

Neurodegeneration Nerve Degeneration Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fruit juice beverage

Other

500ml fruit juice beverage, single dose per visit

Other names: Tropicana Ruby Breakfast, Copella English Apple, Robinson's Lemon Barley Water

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 10, 2011
Registry last updated
Nov 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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