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

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Conditions studied: Metabolic Dysfunction-associated Liver Disease

In brief

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.

Key facts

Study ID: NCT07503431
Run by: Miguel López Moreno
People needed: 50
Starts: 2026-04-18
Expected to finish: 2027-03-10
Last updated by the study team: 2026-04-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults aged 18 to 75 years.
Diagnosis of metabolic dysfunction-associated liver disease (MetLD) based on evidence of hepatic steatosis by ultrasound or transient elastography with controlled attenuation parameter (CAP) ≥ 275 dB/m, or liver biopsy.
Body mass index (BMI) between 25 and 38.5 kg/m².

You may not qualify if…

Liver disease of etiology other than MetLD.
Any condition requiring specific dietary treatment and/or limiting adherence to a plant-based diet.
Acute or chronic diseases that may reduce life expectancy.
Type 1 diabetes mellitus.
Use of weight-loss medications (e.g., incretin-based therapies) or initiation of glucose-lowering medication within the past 6 months.
Pregnancy or breastfeeding.
Pharmacological treatments that may interfere with study outcomes (e.g., corticosteroids or biological therapies).
Uncontrolled psychiatric disorders.
Inability to provide informed consent.

Where it is running

Hospital Puerta del Hierro — Madrid, Spain

Full record on ClinicalTrials.gov

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