Effects of Cocoa Flavanols on Human Cognitive Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01344551
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : February 21, 2013
Information provided by (Responsible Party):
Jeremy Paul Edward Spencer, University of Reading

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

Condition or disease Intervention/treatment
Neural Degeneration Dietary Supplement: Cocoa Drink

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  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : February 2009
Primary Completion Date : January 2013
Study Completion Date : January 2013

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

Primary Outcome Measures :
  1. Executive function - attention [ Time Frame: change from baseline to 2 hours ]

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: change from baseline to 2 hours ]
  2. Plasma flavanols [ Time Frame: change from baseline to 2 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01344551

United Kingdom
University of Reading
Reading, Berkshire, United Kingdom, RG2 9AR
Sponsors and Collaborators
University of Reading
Principal Investigator: Jeremy Spencer, PhD University of Reading
Principal Investigator: Laurie Butler, PhD University of Reading

Responsible Party: Jeremy Paul Edward Spencer, Professor of Nutritional Medicine, University of Reading Identifier: NCT01344551     History of Changes
Other Study ID Numbers: UReading-2011-02
First Posted: April 29, 2011    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Nerve Degeneration
Pathologic Processes