Effects of Cocoa Flavanols on Human Cognitive Function

Sponsors

Lead Sponsor: University of Reading

Source 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.

Overall Status Completed
Start Date February 2009
Completion Date January 2013
Primary Completion Date January 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Executive function - attention change from baseline to 2 hours
Secondary Outcome
Measure Time Frame
Blood pressure change from baseline to 2 hours
Plasma flavanols change from baseline to 2 hours
Enrollment 63
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Cocoa Drink

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

Eligibility

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

Gender: All

Minimum Age: 60 Years

Maximum Age: 75 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility: University of Reading
Location Countries

United Kingdom

Verification Date

February 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Reading

Investigator Full Name: Jeremy Paul Edward Spencer

Investigator Title: Professor of Nutritional Medicine

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: High Flavanol

Type: Active Comparator

Description: High Flavanol cocoa drink containing 495mg cocoa

Label: Low Flavanol

Type: Placebo Comparator

Description: Low Flavanol cocoa drink (23mg)

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov