STRENGTHS AND LIMITATIONS OF THIS STUDY
BLIND
This is the first randomised controlled trial designed to evaluate the effect of an optimised protein-enriched Mediterranean diet, with and without exercise, on nutritional status and cognitive performance in a high-risk population.The integration of state-of-the-art metabolomics, metabolic, inflammatory and nutritional biomarkers will help elucidate biological mechanisms underlying how diet can influence nutrition status and cognition and how exercise can interact with nutrition to modify these processes.A patient and public involvement group will contribute at all stages of the PROMED-EX trial to optimise the research design and dissemination strategy of the research findings.The nature of the ‘real-world’ pragmatic study design means that it is not possible to blind participants to treatment allocation, possibly leading to performance bias.Data will be analysed by a blinded member of the study team to minimise detection bias.