Effects of Cocoa Flavanols on Human Cognitive Function

Not Applicable

Completed

• Conditions: Neural Degeneration
• Interventions: Dietary Supplement: Cocoa Drink

• Registration Number: NCT01344551
• Lead Sponsor: University of Reading

Brief Summary

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

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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Flavanol	Cocoa Drink	High Flavanol cocoa drink containing 495mg cocoa
Low Flavanol	Cocoa Drink	Low Flavanol cocoa drink (23mg)

Primary Outcome Measures

Name	Time	Method
Executive function - attention	change from baseline to 2 hours

Secondary Outcome Measures

Name	Time	Method
Blood pressure	change from baseline to 2 hours
Plasma flavanols	change from baseline to 2 hours

Trial Locations

Locations (1)

University of Reading; 🇬🇧 Reading, Berkshire, United Kingdom