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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN68970511
Enrollment
90
Registered
2014-08-12
Start date
2006-12-04
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Age-related changes of cognitive performance Mental and Behavioural Disorders

Interventions

Participants were randomized to consume daily for 8 weeks a drink containing 993 mg, 520 mg or 48 mg of cocoa flavanols

Sponsors

Mars, Incorporated (USA)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026