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Journal Article Randomized Controlled Trial Ppublish 1 citation

PubMed: 42331287 DOI: 10.1016/j.jhepr.2026.101929

Impact of weight loss and reduction of ultra-processed foods on liver fat content in MASLD: A randomized controlled trial.

JHEP Rep 8(9):101929

Authors: Simona Bo, Angelo Armandi, Gabriele Castelnuovo, Ilaria Goitre, Fabio Bioletto, Marta Guariglia, Nuria Perez Diaz Del Campo, Eleonora Dileo, Valentina Ponzo, Francesca Saba, Chiara Rosso, Gian Paolo Caviglia, Elisabetta Bugianesi

Affiliations

  • Division of Clinical Nutrition, Department of Medical Sciences, University of Turin, Italy.
  • Division of Gastroenterology and Hepatology, Department of Medical Sciences, University of Turin, Italy.
  • Division of Endocrinology, Diabetes and Metabolism, Department of Medical Sciences, University of Turin, Italy.
  • Division of Gastroenterology and Hepatology, Department of Medical Sciences, University of Turin, Italy.

Abstract

BACKGROUND & AIMS

Dietary interventions are a cornerstone of management for metabolic dysfunction-associated steatotic liver disease (MASLD). However, it remains unclear whether specific dietary patterns confer benefits beyond weight loss. We aimed to compare the effects of different dietary strategies on liver fat and metabolic health in patients with MASLD.

METHODS

We conducted a 6-month, three-arm, parallel-group randomized controlled trial including patients with MASLD and overweight or obesity who were naïve to structured nutritional counselling. Participants were randomized to Mediterranean diet (MeD), low-carbohydrate, high-protein diet (LCHO), or standard nutritional recommendations. Liver fat content was assessed by controlled attenuation parameter (CAP). Secondary outcomes included changes in anthropometric and metabolic parameters, body composition, and ultra-processed food (UPF) consumption. Structural equation modelling was used to investigate pathways linking dietary allocation, weight loss, and UPF intake with changes in CAP.

RESULTS

Of 173 enrolled participants, 148 (85.5%) completed the study. CAP decreased significantly within the LCHO and control groups (Δ -19.5 [-48.8 to 8.0], p = 0.004 and -11.0 [-32.0 to 12.0], p <0.001), with no significant between-group differences. All study arms achieved significant improvements in body weight, BMI, adiposity measures, metabolic profile, and dietary quality, including reductions in UPF intake. Structural equation modelling analyses showed no direct or total effect of dietary pattern on changes in CAP. In contrast, reductions in BMI and UPF consumption independently and significantly predicted CAP improvements: β = 14.34 (95% CI 10.55-18.13), and β = 0.64 (95% CI 0.25-1.03).

CONCLUSIONS

In patients with MASLD, weight loss and reductions in UPF intake, rather than diet type, were the main drivers of improvements in liver fat and metabolic health. These findings support a patient-centered dietary approach in MASLD management.

CLINICAL TRIAL NUMBER

NCT073043336.

IMPACT AND IMPLICATIONS

This randomized controlled trial shows that weight loss and reductions in ultra-processed food intake, rather than the specific dietary pattern, are the primary factors associated with improvements in liver fat and metabolic health in MASLD. These findings challenge the emphasis on prescriptive dietary models and support a more flexible, patient-centered approach focused on sustainable weight reduction and improved dietary quality. Prioritizing reduction of ultra-processed foods may represent a practical and scalable strategy to enhance adherence and maximize long-term clinical benefit in routine care.

MeSH

Liver, Diet, Food, Weight Loss, Metabolic Syndrome, Food, Processed, Dietary Patterns