Effects of Flavonoids on Cognitive Performance in Healthy... | NCT01312597

Studies
Effects of Flavonoids on Cognitive Performance in Healthy Young Adults

NCT01312597

Sponsor

University of Reading

Status

Completed

Last Update Posted

Nov 23, 2011Estimated

Enrollment

30Actual

Phase

Phase 2

Conditions

Neurodegeneration

Interventions

Fruit juice beverage

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

Nov 2011

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

Oct 2010

Primary Completion Date

Aug 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Mar 9, 2011

First Submission Date that Met QC Criteria

Mar 9, 2011

First Posted Date

Mar 10, 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

Nov 22, 2011

Last Update Posted Date

Nov 23, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeremy Paul Edward Spencer, Professor of Biochemistry, 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

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.

Detailed 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.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fruit beverage	Experimental		Other: Fruit juice beverage
Control beverage	Experimental		Other: Fruit juice beverage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fruit juice beverage	Other	500ml fruit juice beverage, single dose per visit	Control beverage Fruit beverage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

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

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D009410	Nerve Degeneration

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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