AS495 - COcoa Supplement and Multivitamin Outcomes Study in the Mind (COSMOS-Mind)

Investigator Names and Contact Information

Laura Baker (ldbaker@wakehealth.edu)

Mark Espeland

Introduction/Intent

The results of basic science, observational, and a few small RCTs point to a beneficial effect of cocoa flavanols on brain function and cognition, but these findings have yet to be tested in longer duration large-scale trials. Preliminary evidence showing beneficial effects of cocoa flavanols on medical conditions that can accelerate cognitive aging such as cardiovascular and cerebrovascular disease, and insulin resistance, provide the additional impetus to examine treatment effects on cognition in COSMOS participants. The evidence that multivitamins may benefit cognitive function is mixed, with some randomized trials reporting benefits, but others showing no effect. This ancillary provides a cost-effective means to potentially resolve this controversy.

Specific Aims

Our primary hypotheses will test whether, compared to placebo, 1) cocoa extract results in better cognitive functioning over 3 years in men and women 65 years of age and older, and 2) the daily multivitamin results in better cognitive functioning over 3 years in men and women 65 years of age and older. The primary measure for these hypotheses will be a composite score formed from individual measures of global cognitive function, executive control, and short-term memory. Secondary aims will be to examine 1) synergistic effects of cocoa extract and the multivitamin on cognitive function, and 2) the consistency of treatment response across subgroups of participants defined by age, sex, body mass index, baseline global cognitive function, depressive symptoms, and medical conditions such as hypertension and diabetes. Tertiary aims will be to 1) assess intervention effects on cognition as they relate to health outcomes measured in the parent trial (e.g., CVD and cancer events), and 2) share data from standardized assessments of cognitive function with the COSMOS study group, including its ancillary studies, increasing the scientific footprint of the study.