Effects of Cocoa Flavanols on Human Cognitive Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeremy Paul Edward Spencer, University of Reading
ClinicalTrials.gov Identifier:
NCT01344551
First received: April 27, 2011
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention
Neural Degeneration
Dietary Supplement: Cocoa Drink

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Further study details as provided by University of Reading:

Primary Outcome Measures:
  • Executive function - attention [ Time Frame: change from baseline to 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: change from baseline to 2 hours ] [ Designated as safety issue: No ]
  • Plasma flavanols [ Time Frame: change from baseline to 2 hours ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: February 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344551

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

No publications provided

Responsible Party: Jeremy Paul Edward Spencer, Professor of Nutritional Medicine, University of Reading
ClinicalTrials.gov Identifier: NCT01344551     History of Changes
Other Study ID Numbers: UReading-2011-02
Study First Received: April 27, 2011
Last Updated: February 20, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Nerve Degeneration
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014