Abstract
INTRODUCTION: Psychological disorders including depression and anxiety are significant public health concerns. A Mediterranean-style dietary pattern (MDP) has been associated with improved mental well-being in observational studies. Evidence of the acute (defined as postprandial to 1 week) effects of an MDP on brain function, mood, cognition and important modulators, including sleep and the gut microbiota is limited. The current intervention aims to examine whether an MDP, compared with a Western diet (WD), improves mood, cognition and anxiety symptoms, postprandially, at 24-hour and after 5 days in adults with mild to moderate anxiety and depression. METHODS AND ANALYSIS: Twenty-five UK adults (aged 18 or over) with mild to moderate anxiety and/or depression and low adherence to an MDP were recruited to a cross-over randomised controlled trial. Each participant undergoes a 5 day MDP and a 5 day WD in a randomised order with all meals provided. The co-primary outcomes are mood and anxiety, with secondary outcomes including cognitive function, brain perfusion (as assessed by MRI), sleep quality, blood pressure, plasma glucose, insulin, lipids, C-reactive protein, cortisol, brain-derived neurotrophic factor, gut microbiota speciation and microbial metabolites including short chain fatty acids. A linear mixed model and/or paired analysis will be used to compare the effects of treatments over time. ETHICS AND DISSEMINATION: The study has received a favourable ethics opinion from the National Health Service London Queen Square Research Ethics Committee (22/LO/0796). The results will be disseminated through scientific journals and conferences. TRIAL REGISTRATION NUMBER: NCT05927376.