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Completed

NCT Number: NCT01344551

Effects of Cocoa Flavanols on Human Cognitive Function

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

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Key information

Conditions

Neural Degeneration Nerve Degeneration Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, Berkshire, RG2 9AR, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cocoa Drink

Dietary Supplement

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

Primary outcomes

  1. Executive function - attention

    Time frame: change from baseline to 2 hours

Secondary outcomes

  1. Blood pressure

    Time frame: change from baseline to 2 hours

  2. Plasma flavanols

    Time frame: change from baseline to 2 hours

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Apr 29, 2011
Registry last updated
Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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