Effect of a Sustainable, Plant-Based Dietary Pattern on Nutritional, Metabolic and Health Status: The MED_EAT-IT Study Protocol

Objectives: Sustainable diets are important to reduce environmental impact and promote human health. The aim of the study is to evaluate the effect of a sustainable plant-based dietary pattern implemented following the recommendation of the EAT-Lancet Commission on Healthy Diet from Sustainable Food Systems and adapted to the Italian food context. Methods: The study is an 8-week, randomized, controlled, crossover intervention trial in which adult volunteers are randomly assigned to one of two intervention groups: the MED_EAT-IT diet or a control diet. The MED_EAT-IT pattern has been optimized to promote personalized recommendations based on individual characteristics (i.e. energy and nutrient need but also food habits and preferences) while reducing as much as possible the environmental impact. It consists of three main meals and 1-2 snacks and it is characterized by a larger amount of legumes and nuts with respect to the control diet based on the Italian Food-Based Dietary Guidelines (IT-FBDG) matched for energy and nutrient intake. Each intervention is separated by at least 6-week washout period. Before and after each intervention, food records, anthropometric characteristics, blood, urine and fecal samples are collected. The study will investigate the effect of the diet on adoption, eating behavior, nutrient intake, nutritional status, physiological function and individual metabolic features. The impact on gut microbial ecosystem will be investigated as main outcome. Proteomic and metabolomic approaches are exploited to identify nutritional, metabolic and functional biomarkers. Results: N/A. Conclusions: The study will contribute to the validation of plant based dietary patterns able to cover nutrient needs (one of the potential issues in such patterns) considering also environmental constraints and national eating habits. The effect on health related outcomes will be possibly mediated by the improvement of microbial ecosystem and short chain fatty acids production able to favourably affect metabolic and physiological function of the host. Funding Sources: National Recovery and Resilience Plan (NRRP), Mission 4 Component 2 Investment 1.3 by the Italian Ministry of University and Research through the European Union—NextGenerationEU funding (OnFoods project) and ERA-NET ERA-HDHL (SYSTEMIC project).