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

Comparing the Efficacy of Dietary Strategies in Managing Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): a Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: MASLD
• Intervention / Treatment: Behavioral: Low-Carb diet; Behavioral: Mediterranean diet; Behavioral: Standard Lifestyle Recommendations

Detailed Description

This is a three-arm, parallel-group, open-label randomized controlled trial designed to evaluate the effectiveness of three different nutritional interventions on non-invasive markers of liver damage, including radiological and biochemical assessments. Patients with MASLD were recruited from the Liver Unit of the Department of Medical Sciences, University of Torino.

At baseline, participants were randomly assigned to one of the following three groups:

A) Low-carb Diet (LCHO: 35-40% carbohydrates, 30% protein, 30-35% fats.) B) Mediterranean Diet (MeD: 50-60% carbohydrates, 15% protein, 25-35% fats ) C) Control group: standard nutritional recommendations The following evaluations were performed both at baseline and after 6 months at the and 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).

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Torino
    • Torino, Torino, Italy, 10126
      • AOU Città della Salute e della Scienza di Torino, University of Torino, Torino.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age ≥18 and <75 years
• BMI ≥25 and <35 kg/m2
• not having previously received nutritional advice for the liver disease

Exclusion Criteria:

• other causes of liver disease (including viral, autoimmune, cholestatic, genetic, alcoholic, and drug-induced)
• other diseases or conditions requiring specific dietary recommendations
• a history of alcohol abuse
• diabetes mellitus
• pharmacological treatments potentially interfering with study outcomes (corticosteroids, glucagon-like-peptide 1 agonists, biologic drugs)
• pregnancy or breastfeeding
• inability to give written informed consent
• life expectancy expected to be <1 year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group	Behavioral: Standard Lifestyle Recommendations; Participants received standard nutritional raccomandations for 6 months, including guidance on healthy eating, advices for regular physical activity, and educational materials consistent with standard clinical practice. No specific dietary plan was prescribed.
Experimental: Low-Carb Diet (LCHO)	Behavioral: Low-Carb diet; Participants followed a low-carbohydrate diet for 6 months. Macronutrient distribution: 35-40% carbohydrates, 30% protein, 30-35% fats. The diet was tailored based on participants' energy requirements.
Experimental: Mediterranean Diet (MeD)	Behavioral: Mediterranean diet; Participants followed a Mediterranean-style diet for 6 months, providing 50-60% of energy from carbohydrates, approximately 15% from protein, and 25-35% from fat. The diet was tailored to individual energy requirements and patients in this group, should consume moderate portions of fish, poultry, and dairy products. The recommended cereal servings were larger than those for the LCHO arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Within- and between-group changes in hepatic steatosis [percentage, %]	The unit of measure is the percentage (%) of liver fat content, as assessed by transient elastography - FibroScan®.	6 months
Within- and between-group changes in Controlled Attenuation Parameter. (CAP) [dB/m]	The unit of measure is decibels per meter (dB/m), as measured by transient elastography - FibroScan®.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in liver stiffness measured by transient elastography - FibroScan®. [kilopascals, kPa]	Liver stiffness will be assessed using transient elastography - FibroScan®.	6 months
Changes in fat mass percentage	Within- and between-groups changes in fat mass percentage measured by bioelectrical impedance analysis	6 months
Changes in energy expenditure.	Within- and between-group changes in energy expenditure measured by indirect calorimetry.	6 months
Changes in insulin restistance [mmol/LxμU/mL]	Within- and between-group changes in HOMA-IR [mmol/LxμU/mL]	6 months
Changes in serum transaminase levels	Within- and between-group changes in serum transaminase levels [U/L]	6 months
Changes in thrombospondin-2 (TSP2) [ng/ml]	Assessing serum Thrombospondin-2 (TSP2) changes across incremental delta of weight loss	6 months
Changes in C-terminal procollagen 4 (PRO-C4) [ng/ml]	Assessing serum C-terminal procollagen 4 (PRO-C4) changes across incremental delta of weight loss	6 months
Changes in fibrosis-4 index	Within- and between-group changes in fibrosis-4 index, a non-invasive score for liver fibrosis calculated by the following formula: FIB-4= (age x AST / (platelet count (x 10 9 ) x√ALT). This index has no fixed upper limit; higher values indicate worse fibrosis.	6 months

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): February 24, 2025
• Study Completion (Actual): February 24, 2025

Study Registration Dates

• First Submitted: October 2, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Estimated): December 26, 2025

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Nutrition intervention; Hepatic disorders; MASLD
• Additional Relevant MeSH Terms: Digestive System Diseases; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Diet; Diet, Mediterranean
• Other Study ID Numbers: MASLD_DIET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No