NCT01312597

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

10 months

First QC Date

March 9, 2011

Last Update Submit

November 22, 2011

Conditions

Neurodegeneration

Keywords

FlavonoidCognitive performanceCognitive functionExecutive functionfMRICerebral blood flowAcute

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Cerebral blood flow

    change in attention between baseline and 2h

Study Arms (2)

Fruit beverage

EXPERIMENTAL
Other: Fruit juice beverage

Control beverage

EXPERIMENTAL
Other: Fruit juice beverage

Interventions

Fruit juice beverageOTHER

500ml fruit juice beverage, single dose per visit

Also known as: Tropicana Ruby Breakfast, Copella English Apple, Robinson's Lemon Barley Water
Control beverageFruit beverage

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • MMSE between 26 and 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

MeSH Terms

Conditions

Nerve Degeneration

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeremy PE Spencer, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Biochemistry

Study Record Dates

First Submitted

March 9, 2011

First Posted

March 10, 2011

Study Start

October 1, 2010

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations

GB(1)