Effects of Cocoa Flavanols on Human Cognitive Function

NCT ID: NCT01344551

Last Updated: 2013-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Neural Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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High Flavanol

High Flavanol cocoa drink containing 495mg cocoa

Group Type ACTIVE_COMPARATOR

Cocoa Drink

Intervention Type DIETARY_SUPPLEMENT

High Flavanol (495mg) Low Flavanol (23mg) Matched for macro and micro nutrients

Low Flavanol

Low Flavanol cocoa drink (23mg)

Group Type PLACEBO_COMPARATOR

Cocoa Drink

Intervention Type DIETARY_SUPPLEMENT

High Flavanol (495mg) Low Flavanol (23mg) Matched for macro and micro nutrients

Interventions

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Cocoa Drink

High Flavanol (495mg) Low Flavanol (23mg) Matched for macro and micro nutrients

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Paul Edward Spencer

Professor of Nutritional Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeremy Spencer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Laurie Butler, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

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University of Reading

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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UReading-2011-02

Identifier Type: -

Identifier Source: org_study_id

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