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

NCT ID: NCT07304336

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2025-02-24

Brief Summary

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).

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).

Conditions

MASLD

Keywords

Hepatic disorders; MASLD; Nutrition intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-Carb Diet (LCHO)

Group Type: EXPERIMENTAL

Low-Carb diet

Intervention Type: OTHER

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.

Mediterranean Diet (MeD)

Group Type: EXPERIMENTAL

Mediterranean diet

Intervention Type: OTHER

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.

Control group

Group Type: PLACEBO_COMPARATOR

Standard Lifestyle Recommendations

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Simona Bo

Associate Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Torino, Torino, Italy

Countries

Italy

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

MASLD_DIET

Identifier Type: -

Identifier Source: org_study_id