Effects of Cocoa Flavanols on Human Cognitive Function | NCT01344551

Studies
Effects of Cocoa Flavanols on Human Cognitive Function

NCT01344551

Sponsor

University of Reading

Status

Completed

Last Update Posted

Feb 21, 2013Estimated

Enrollment

63Actual

Phase

Not Applicable

Conditions

Neural Degeneration

Interventions

Cocoa Drink

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

Feb 2009

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Apr 27, 2011

First Submission Date that Met QC Criteria

Apr 28, 2011

First Posted Date

Apr 29, 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

To determine the acute and chronic effects of cocoa derived flavonoids on cognitive function in healthy older adults.

Detailed Description

This is a randomised controlled double blind cross over study investigating the acute effects of high flavanol (495mg) compared to low flavanol (23mg)cocoa drink on cognitive function in a healthy older adult population (n=60). The primary outcome measure of this study is to determine the effects of the flavanol intervention on cognitive measures of executive function and attention and the secondary measures of blood pressure and to determine whether any observed effects are paralleled by plasma flavanol levels.

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

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High Flavanol	Active Comparator	High Flavanol cocoa drink containing 495mg cocoa	Dietary Supplement: Cocoa Drink
Low Flavanol	Placebo Comparator	Low Flavanol cocoa drink (23mg)	Dietary Supplement: Cocoa Drink

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cocoa Drink	Dietary Supplement	High Flavanol (495mg) Low Flavanol (23mg) Matched for macro and micro nutrients	High Flavanol Low Flavanol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Executive function - attention		change from baseline to 2 hours

Secondary Outcomes

Measure	Description	Time Frame
Blood pressure		change from baseline to 2 hours
Plasma flavanols		change from baseline to 2 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 62 - 75 years
A signed consent form

Exclusion Criteria:

Blood pressure > 160/90 mmHg
Haemoglobin (anaemia marker) < 125 g/l
Gamma GT (liver enzymes) > 80 IU/l
Had suffered a myocardial infarction or stroke in the previous 12 months
Suffers from any gastrointestinal/stomach disorder
Suffers from any blood-clotting disorder
On medication for hypertension
Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
Depression or major mental illness
Any dietary restrictions or on a weight reducing diet
Drinking more than 21 units per week
On any medication affecting blood clotting
Smoking
Vegans

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 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 Spencer, PhD	University of Reading	Principal Investigator
Laurie Butler, PhD	University of Reading	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Reading		Reading	Berkshire	RG2 9AR	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

Browse Leaves

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Browse Branches

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