CARES is a double-blind, placebo-controlled, randomised clinical trial designed to investigate the impact of nutritional supplementation on cognitive function among individuals with mild cognitive impairment (MCI) in comparison to controls. Individuals with MCI and controls were each randomised in 50:50 masked fashion to receive either the active intervention (containing 10mg lutein, 10mg meso-zeaxanthin, 2mg zeaxanthin, 15mg vitamin E and 1g fish oil) or placebo for 24 months.
Given that carotenoids, omega-3 fatty acids and vitamin E are present in brain tissue, and given their ability to attenuate the mechanisms involved in the pathogenesis of Alzheimer’s disease (namely oxidative stress and neuro-inflammation), it is likely that they play a significant neuroprotective role by maintaining and optimising cognition and reducing the risk of cognitive decline. Importantly, previous studies have shown that cognitively impaired individuals are deficient in these nutritional compounds in comparison to cognitively healthy individuals. Therefore, it is likely that specific population groups (i.e. individuals with MCI) will benefit from nutritional intervention. However, well designed and appropriately powered interventional trials are needed to confirm this hypothesis. CARES is designed to answer this important research question.