Mediterranean-DASH Intervention for Neurodegenerative Delay Diet to Improve Cognitive Function in Mild Stroke Patients: Rationale and Design of Two Replicate, Pilot Randomized Control Trials.

Abstract

Introduction: Approximately one-third of stroke survivors develop post-stroke cognitive impairment (PSCI), yet effective preventive strategies remain limited. The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet was originally developed to promote cognitive health, but its effect on changes in cognitive function among mild stroke patients remains unclear. In this study, we aimed to explore the effect of MIND intervention on cognitive function among mild stroke patients. By implementing the same protocol in two independent samples, we aimed to examine whether the results are reproducible across different recruitment waves and refine protocols for future large-scale trials.

Methods: The MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) and MINDICOMS II are two replicate, pilot, two-arm RCTs, each enrolling 60 patients aged 35-70 years with acute ischemic stroke and signs of newly onset cognitive impairment but no dementia. The participants will be randomly assigned to the MIND diet intervention group or a control group. We adapted the MIND diet for the Chinese population, recommending eleven food groups and restricting four food groups. During the 26-week intervention phase, participants in the control group will receive standard medical care along with weekly health education messages. The intervention group will receive a structured MIND diet education program, including in-hospital provision of MIND-compliant meals for 7 days, and post-discharge supplies of nuts, olive or camellia oil, whole grains, and green tea. Personalized dietary guidance and regular feedback from dietitians will be delivered via an online platform. The primary outcome measure is change in global cognitive function measured using a neuropsychological test battery at weeks 0, 13, and 26. Secondary outcomes include changes in domain-specific cognitive function, brain imaging markers, dietary behavior, the ability of daily living, mental health indicators, plasma biomarkers, and the gut microbiota composition.

Conclusion: The MINDICOMS trials will generate preliminary evidence to optimize dietary strategies for cognitive improvement in stroke survivors. The comprehensive set of outcome measures will also offer a unique opportunity to explore potential biological mechanisms and generate new hypotheses for future research.