Study on the effects of cocoa flavanols on cognitive function in elderly subjects

ISRCTN	ISRCTN68970511
DOI	https://doi.org/10.1186/ISRCTN68970511
Protocol serial number	N/A
Sponsor	Mars, Incorporated (USA)
Funder	Mars

Submission date: 06/08/2014
Registration date: 12/08/2014
Last edited: 04/03/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Human epidemiological studies suggest that an antioxidant called flavonoid may have beneficial effects on cognitive function (i.e. thinking, remembering, judging, and problem-solving) in elderly people. It is thought that one class of flavonoid, the flavanols, which are found in tea, grapes, red wine, apples and cocoa products may be able to prevent, to at least some degree, a decline in cognitive function. This study looks at the effect of drinking flavanol-rich cocoa drinks on the cognitive function in older people.

Who can participate?
Adults aged at least 60 with no evidence of a decline in cognitive function.

What does the study involve?
Participants are randomly allocated to one of three groups. Group 1 are given a cocoa drink containing 993 mg of cocoa flavanols. Group 2 are given a cocoa drink containing 520 mg of cocoa flavanols. Group 3 are given a cocoa drink containing 48 mg of cocoa flavanols.

What are the possible benefits and risks of participating?
There are no direct benefits to taking part in the trial. There are no risks in taking part in the trial either, as the products have been used in previous studies and are well-tolerated.

Where is the study run from?
A number of community centers in the L'Aquila district, central Italy.

When is the study starting and how long is it expected to run for?
December 2006 to July 2008.

Who is funding the study?
Mars Incorporated (USA)

Who is the main contact?
Giovambattista Desideri
giovambattista.desideri@cc.univaq.it

Contact information

Prof Giovambattista Desideri
Scientific

Viale S. Salvatore, delta 6 Medicina
Coppito - L'Aquila
67100
Italy

Email	giovambattista.desideri@cc.univaq.it

Study information

Primary study design	Interventional
Study design	Single-center double-blind randomized controlled parallel-arm study
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	Evaluation of the effects of short term (eight weeks) flavanol-rich product consumption on cognitive function in elderly subjects: Cocoa, Cognition and Aging (CoCoA) Study
Study objectives	The CocoA study was designed to test the hypothesis that the regular dietary inclusion of a beverage containing cocoa flavanols would be effective in improving cognitive performance in elderly subjects with no evidence of cognitive dysfunction
Ethics approval(s)	Ethics Committee of Public Health Agency of L'Aquila (Italy), 07/12/2005, ref. 35/2005.
Health condition(s) or problem(s) studied	Age-related changes of cognitive performance
Intervention	Participants were randomized to consume daily for 8 weeks a drink containing 993 mg, 520 mg or 48 mg of cocoa flavanols
Intervention type	Other
Primary outcome measure(s)	Main outcome measures examined were changes in cognitive function following 8 weeks of regular cocoa flavanol consumption. Cognitive testing was performed using a combination of four well validated standardized tests: Mini Mental State Examination, Trail Making Test A and B and verbal fluency test. As predefined procedure, an integrated measure of overall cognitive function - composite cognitive z-score - was also constructed for each participant
Key secondary outcome measure(s)	Secondary outcome measures examined included: 1. Changes in blood pressure 2. Metabolic parameters 3. Plasma isoprostanes and markers of lipid peroxidation These were assessed at 8 week together with neuropsychological evaluation
Completion date	30/07/2008

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	90
Key inclusion criteria	Subjects aged 60 years or more who reported themselves as unconcerned about their own memory functions and having no clinically significant co-existing medical conditions.
Key exclusion criteria	1. Clinically significant co-existing medical conditions, including: 1.1. Known cardiovascular disease 1.2. Cerebrovascular events 1.3. Obesity or weight change ±10% body weight within the last 6 months before entering 1.4. Thyroid disorders 1.5. Inflammatory diseases 1.6. Neurological disorders 1.7. Dementia 1.8. Depression 2. Current smokers 3. Habitual users of antioxidant supplements 4. Habitual consumers of chocolate or other cocoa products 5. Individuals prescribed medications known to have antioxidant properties or to interfere with cognitive functions
Date of first enrolment	04/12/2006
Date of final enrolment	30/07/2008

Locations

Countries of recruitment

Italy

Study participating centre

Viale S. Salvatore, delta 6 Medicina

Coppito - L'Aquila
67100
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes