Deep dive to the secrets of the PREDIMED trial

The aim of this study was to briefly summarize the contribution of the PREDIMED (PREvención con DIeta MEDiterránea) trial on cardiovascular evidence and examine in depth its groundbreaking trajectory.PREDIMED was conducted during 2003-2010 and represented the largest primary prevention trial ever testing the effects of changes in a complete food pattern (namely, the Mediterranean diet) on cardiovascular disease (CVD). Major contributions relied on the relevant changes in the food pattern attained by the behavioural intervention and their robust effect in reducing hard clinical end-points. Given some potential concerns, which were appropriately addressed with supporting analyses, this review is timely and relevant.

PREDIMED has continued contributing to the existing literature with extensive, robust and abundant new evidence on the benefits of the Mediterranean diet, particularly on cardiovascular health, including recent studies using high-throughput metabolomic techniques. After robustly addressing some controversies, the conclusions of the original trial remained unaltered.

The Mediterranean diet represents an effective and robust nutritional strategy against CVD in high cardiovascular risk populations. Recent findings from the PREDIMED have identified a metabolic signature of the Mediterranean diet that can objectively determine dietary adherence and predict CVD risk. This metabolomic signature opens up a new era for nutritional epidemiology and personalized nutrition.