Effects of Flavonoids on Cognitive Performance in Healthy Young Adults

Neurodegeneration Clinical Trial

Official title:

Effects of Flavonoids on Cognitive Performance in Healthy Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312597
• Other study ID #: UReading-2011-01
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2011
• Last updated: November 22, 2011
• Start date: October 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nerve Degeneration
• Neurodegeneration

Intervention

Other:
• Fruit juice beverage
500ml fruit juice beverage, single dose per visit

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Executive function	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	No
Secondary	Cerebral blood flow	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	No