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 measure
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 (if study stopped)
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
Funders
Funder type
Industry
Funder name
Mars
Alternative name(s)
Mars Incorporated
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25733639