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Effects of Cocoa Flavanols on Human Cognitive Function

Sponsor
University of Reading (Other)
Overall Status
Completed
CT.gov ID
NCT01344551
Collaborator
(none)
63
Enrollment
1
Location
2
Arms
47
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Dietary Supplement: Cocoa Drink
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Executive function - attention [change from baseline to 2 hours]

Secondary Outcome Measures

  1. Blood pressure [change from baseline to 2 hours]

  2. Plasma flavanols [change from baseline to 2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 75 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeremy Paul Edward Spencer, Professor of Nutritional Medicine, University of Reading
ClinicalTrials.gov Identifier:
NCT01344551
Other Study ID Numbers:
  • UReading-2011-02
First Posted:
Apr 29, 2011
Last Update Posted:
Feb 21, 2013
Last Verified:
Feb 1, 2013
Additional relevant MeSH terms:
Nerve Degeneration

Study Results

No Results Posted as of Feb 21, 2013