Effects of Cocoa Flavanols on Human Cognitive Function

Neural Degeneration Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344551
• Other study ID #: UReading-2011-02
• Status: Completed
• Phase: N/A
• First received: April 27, 2011
• Last updated: February 20, 2013
• Start date: February 2009
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Nerve Degeneration
• Neural Degeneration

Intervention

Dietary Supplement:
• Cocoa Drink
High Flavanol (495mg) Low Flavanol (23mg) Matched for macro and micro nutrients

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Executive function - attention		change from baseline to 2 hours	No
Secondary	Blood pressure		change from baseline to 2 hours	No
Secondary	Plasma flavanols		change from baseline to 2 hours	No