Multicultural Healthy Diet to Reduce Cognitive Decline & Alzheimer's Disease Risk: Study protocol for a pilot randomized controlled trial

Background: Emerging evidence indicates that healthy dietary patterns are associated with higher cognitive status; however, few clinical trials have explored this association in diverse middle-aged adults before the onset of cognitive decline. We use novel ambulatory methods to assess cognition in natural settings in tandem with diet recording. Aims: We investigate whether the Multicultural Healthy Diet Study to Reduce Cognitive Decline & Alzheimer's Disease Risk, a pilot randomized controlled trial of an anti-inflammatory dietary pattern compared to usual diet, can mitigate cognitive decline and Alzheimer's Disease risk in a diverse population of 40-65 year old adults in Bronx, New York. Methods: Primary cognitive outcomes assessed at nine months are collected in an ecological momentary assessment "measurement burst" design, over the course of participants' daily lives. These ultra-brief, ambulatory cognitive assessments examine processing speed, visuospatial working memory, short-term associative memory binding, long-term associative memory, and working memory capacity. Key secondary outcomes relate to comparing dietary intake between study arms with respect to cognitive outcomes. We assess diet with food records using the National Cancer Institute's Automated Self-Administered 24-h record and serum biomarkers. We further investigate the association of self-reported diet and dietary biomarkers with inflammatory-based biomarkers. Conclusion: This randomized controlled trial of diet and cognition for the first time combines novel measures of ambulatory cognitive assessment with web-based assessment of dietary intake recording. This new approach enabled the study to continue in the midst of the COVID-19 pandemic in remote format.