Effects of Cocoa Flavanols on Human Cognitive Function

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01344551

Enrollment

Registered

2011-04-29

Start date

2009-02-28

Completion date

2013-01-31

Last updated

2013-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neural Degeneration

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.

Interventions

DIETARY_SUPPLEMENTCocoa Drink

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Executive function - attention	change from baseline to 2 hours

Secondary

Measure	Time frame
Blood pressure	change from baseline to 2 hours
Plasma flavanols	change from baseline to 2 hours

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026