Investigating the Acute Effects of Flavonoids in Blueberr... | NCT01289860

Studies
Investigating the Acute Effects of Flavonoids in Blueberries on Cognitive Function.

NCT01289860

Sponsor

University of Reading

Status

Completed

Last Update Posted

Feb 21, 2013Estimated

Enrollment

47Actual

Phase

Not Applicable

Conditions

Healthy Adults.

Interventions

Flavonoids
Control

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Feb 3, 2011

First Submission Date that Met QC Criteria

Feb 3, 2011

First Posted Date

Feb 4, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2013

Last Update Posted Date

Feb 21, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeremy Paul Edward Spencer, Professor of Nutritional Medicine, University of ReadingPrincipal Investigator

Lead Sponsor

University of ReadingOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The control drink was matched to the blueberry drink for other bioactive compounds which may have affected cognition, specifically sugars and vitamin C. Volunteers were healthy, not on any medication, without high blood pressure, high cholesterol, high BMI, diabetes or other medical conditions. Older adults were aged 61-75 years and younger adults 18-26 years.

Blood and urine samples will be analysed for flavonoid levels and Brain Derived Neurotrophic Factor, a biomarker of memory and learning, flavonoids may lead to increased BDNF production through the ERK-CREB-BDNF pathway.

Flavonoids may also increase nitric oxide production and improve the flexibility of the blood vessels hence the measure of vascular reactivity using the Digital Volume Pulse machine. This can lead to increased vaso-dilation and blood flow to the brain, therefore an fMRI study was carried out the investigate this using arterial spin labeling following acute blueberry supplementation compared to a control drink.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Flavonoids	Dietary Supplement	475g of anthocyanidins in 300ml of blueberry drink.	Blueberry drink

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Bioavailability and pharmacology	Flavonoid and BDNF levels in plasma and urine samples.	Pre drink and 1 hour post drink
Vascular Reactivity	Measurements taken using Digital volume pulse equipment. Blood pressure also recorded.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeremy PE Spencer, PhD	University of Reading	Principal Investigator
Laurie T Butler, PhD	University of Reading	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Reading		Reading	Berkshire	RG6 6AP	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
D005419	Flavonoids
D000872	Anthocyanins
D044948	Flavonols

Ancestor Terms

ID	Term
D002867	Chromones
D001578	Benzopyrans
D011714	Pyrans
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided