Dietary Strategies for MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

This is a non-blinded, three-arm, parallel, 6-month randomized, longitudinal, and controlled intervention trial. designed to compare the effects of three dietary regimes (Mediterranean diet, low-carbohydrate diet and standard nutritional recommendations) on non-invasive parameters of fat accumulation and liver damage, including radiological and biochemical tests, in overweight or obese subjects with MASLD. Participants were enrollment and screening from the Liver Unit of the Department of Medical Sciences, University of Torino and randomly assigned to one of three groups: a low-carbohydrate diet, a mediterranean diet, or standard nutritional recommendations. All participants were submitted to the following assessments both at enrollment and at after 6 month at the end of the study: 3-day food record; the Medi-Lite score; anthropometric measurements (weight, height, BMI, waist and neck circumferences); fat mass, fat-free mass by bioelectrical impedance; hand-grip strength; energy expenditure by indirect calorimetry; blood pressure measurement; blood sampling for metabolic variables and biomarkers of liver damage and liver disease measures (Cap, Stiffness and Fib-4).

NCT Number	NCT07304336
Lead Sponsor	University of Turin, Italy
Conditions	MASLD
Enrollment	173 participants
Start Date	2022-02-10
Primary Completion	2025-02-24 (estimated)
Study Completion	2025-02-24 (estimated)
Updated on ClinicalTrials.gov	2026-01-12