NCT01289860

Brief Summary

This study was a controlled, cross-over, acute flavonoid intervention trial with younger and older adults. Subjects consumed a blueberry beverage during one visit and a control beverage on another. Cognitive function pre drink was assessed, blood and urine samples were taken as well as blood pressure and a measure of vascular reactivity. These outcome measures were taken at 2 and 5 hours post drink. It was predicted that the flavonoids in the blueberry drink would lead to improved performance on the cognitive tests and vascular reactivity measure compared to following the control drink. It was thought this could be due to increased vaso-dilation and improving blood flow to the brain which was investigated in an extension to the project where a sample of individuals underwent brain imaging in an MRI scanner pre and post a blueberry and a control drink.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 21, 2013

Status Verified

February 1, 2013

Enrollment Period

3.7 years

First QC Date

February 3, 2011

Last Update Submit

February 20, 2013

Conditions

Healthy Adults.

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    Extensive cognitive test battery including tasks measuring executive function such as updating, and memory tests such as free recall.

    pre drink, 2 hours and 5 hours post drink

Secondary Outcomes (3)

  • Bioavailability and pharmacology

    Pre drink and 1 hour post drink

  • Vascular Reactivity

    Pre and 1 hour post drink

  • Neuronal effects

    Pre and 1 hours post drink

Study Arms (2)

Blueberry drink

ACTIVE COMPARATOR

30g of blueberry powder (equivalent to 200g fresh blueberries) and 300ml of semi-skimmed milk

Dietary Supplement: Flavonoids

Control drink

PLACEBO COMPARATOR

29g of powder consisting of sugars and vitamin C, values of which were matched to that of the blueberry drink, with 1 g of citric acid to match for taste.

Dietary Supplement: Control

Interventions

FlavonoidsDIETARY_SUPPLEMENT

475g of anthocyanidins in 300ml of blueberry drink.

Also known as: Anthocyanidins, flavanols, flavonols.
Blueberry drink
ControlDIETARY_SUPPLEMENT

29g powder: sugars (glucose, sucrose, fructose), vitamin C and citric acid.

Control drink

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No medical conditions
  • Not taking any medication or supplements (or willing to stop taking supplements for duration of study)
  • Not lactose intolerant
  • Willing to give blood and urine samples
  • Not partaking in frequent vigorous exercise
  • Not suffering from or history of depression

You may not qualify if:

  • On blood pressure medication, taking Aspirin or other blood thinning medication
  • BMI \> 30
  • Cholesterol \> 6
  • Diabetes or other serious medical condition
  • Lactose intolerant
  • Any learning difficulty e.g. dyslexia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

MeSH Terms

Interventions

FlavonoidsAnthocyaninsFlavonols

Intervention Hierarchy (Ancestors)

ChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGlycosidesCarbohydratesPigments, BiologicalBiological Factors

Study Officials

  • Jeremy PE Spencer, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

  • Laurie T Butler, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutritional Medicine

Study Record Dates

First Submitted

February 3, 2011

First Posted

February 4, 2011

Study Start

May 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 21, 2013

Record last verified: 2013-02

Locations

GB(1)