Study on the effects of cocoa flavanols on cognitive function in elderly subjects
| ISRCTN | ISRCTN68970511 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68970511 |
| Secondary identifying numbers | N/A |
- 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
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
Scientific
Viale S. Salvatore, delta 6 Medicina
Coppito - L'Aquila
67100
Italy
| giovambattista.desideri@cc.univaq.it |
Study information
| Study design | Single-center double-blind randomized controlled parallel-arm study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 04/12/2006 |
| Completion date | 30/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 90 individuals randomized to three dietary interventions with a ratio 1:1:1 |
| 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
67100
Italy
Sponsor information
Industry
6885 Elm Street
McLean
22101
United States of America
"ROR" |
https://ror.org/028vrr082 |
|---|
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Mars Incorporated, Mars, Incorporated
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
