Clinical Research Directory

Effect of Plant-based Diets on Liver Biomarkers, Cardiometabolic Health, and Exposure to Environmental Contaminants and Endocrine Disruptors in Patients With Metabolic Liver Disease.

Plant-based diets have gained increasing recognition for their sustainability and their benefits on cardiometabolic and liver health. However, evidence regarding their effects in patients with metabolic liver disease (MetLD) remains limited. The primary objective of this project is to compare the effects of a traditional Mediterranean diet and a Mediterranean diet exclusively based on plant-derived foods on liver parameters, cardiometabolic health, gut microbiota, and exposure to environmental contaminants in patients with MetLD. This study is a randomized clinical trial with a 1:1 allocation ratio into two groups: a traditional Mediterranean diet, considered the standard diet in our setting and recommended for this condition, and a Mediterranean diet exclusively based on plant-derived foods, both designed by registered dietitians. The intervention will last 12 weeks. Anthropometric, metabolic, hepatic, inflammatory, and quality of life variables will be assessed. Additionally, gut microbiota, genetic variants associated with MetLD, and internal exposure to environmental contaminants will be evaluated using biological samples. A 4-week follow-up after the intervention will also be conducted to assess the integration of lifestyle recommendations among participants. The results will contribute to the development of safe, sustainable, and cost-effective nutritional strategies and may serve as a basis for future clinical guidelines integrating precision nutrition and planetary health in the management of chronic liver diseases. The traditional Mediterranean diet has shown metabolic and hepatic benefits; however, its reformulation toward a predominantly plant-based pattern may enhance these effects by reducing saturated fat intake and increasing the consumption of fiber, bioactive compounds, and fatty acids with a more favorable profile. Moreover, this type of diet limits the intake of animal-based foods associated with the bioaccumulation of environmental contaminants such as PFAS and heavy metals, which are increasingly implicated in the progression of MetLD. This project hypothesizes that a Mediterranean diet based exclusively on plant-derived foods, compared to a traditional Mediterranean diet, will lead to greater improvements in hepatic, metabolic, and inflammatory parameters in patients with MetLD, and will additionally be associated with a lower internal burden of bioaccumulative environmental contaminants. Primary objective To evaluate the effect of a Mediterranean diet based exclusively on plant-derived foods on MetLD, assessed non-invasively through biochemical and elastographic parameters. Secondary objectives To evaluate changes in metabolic parameters, anthropometric measures, and body composition. To examine changes in systemic inflammatory markers, such as C-reactive protein and the neutrophil-to-lymphocyte ratio. To assess exposure to environmental contaminants, specifically heavy metals (lead, cadmium, mercury) and endocrine disruptors such as perfluorinated compounds (PFAS), and their relationship with liver damage. To evaluate whether genetic variants associated with susceptibility to and progression of MetLD modulate hepatic and metabolic responses to dietary patterns. To analyze changes in gut microbiota following the plant-based diet and their association with liver improvement.