Condition category
Mental and Behavioural Disorders
Date applied
06/08/2014
Date assigned
12/08/2014
Last edited
04/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Giovambattista Desideri

ORCID ID

Contact details

Viale S. Salvatore
delta 6 Medicina
Coppito - L'Aquila
67100
Italy
-
giovambattista.desideri@cc.univaq.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

Ethics Committee of Public Health Agency of L'Aquila (Italy), 07/12/2005, ref. 35/2005.

Study design

Single-center double-blind randomized controlled parallel-arm study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

04/12/2006

Overall trial end date

30/07/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

90 individuals randomized to three dietary interventions with a ratio 1:1:1

Participant 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

Recruitment start date

04/12/2006

Recruitment end date

30/07/2008

Locations

Countries of recruitment

Italy

Trial participating centre

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

Sponsor information

Organisation

Mars, Incorporated (USA)

Sponsor details

6885 Elm Street
McLean
22101
United States of America

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Mars

Alternative name(s)

Mars Incorporated

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25733639

Publication citations

Additional files

Editorial Notes