Effects of Cocoa Flavanols on Human Cognitive Function

February 20, 2013 updated by: Jeremy Paul Edward Spencer, University of Reading
To determine the acute and chronic effects of cocoa derived flavonoids on cognitive function in healthy older adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG2 9AR
        • University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Flavanol
High Flavanol cocoa drink containing 495mg cocoa
Dietary supplement: Cocoa Drink
High Flavanol (495mg) Low Flavanol (23mg) Matched for macro and micro nutrients
Placebo Comparator: Low Flavanol
Low Flavanol cocoa drink (23mg)
Dietary supplement: Cocoa Drink
High Flavanol (495mg) Low Flavanol (23mg) Matched for macro and micro nutrients

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Investigators

  • Principal Investigator: Jeremy Spencer, PhD, University of Reading
  • Principal Investigator: Laurie Butler, PhD, University of Reading

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

April 28, 2011

First Posted (Estimate)

April 29, 2011

Study Record Updates

Last Update Posted (Estimate)

February 21, 2013

Last Update Submitted That Met QC Criteria

February 20, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UReading-2011-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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