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

University of Turin

Status: Completed

Conditions: MASLD

Treatments: Behavioral: Mediterranean diet; Behavioral: Low-Carb diet; Behavioral: Standard Lifestyle Recommendations

Study type: Interventional

Funder types: Other

Identifiers

NCT07304336

MASLD_DIET

Details and patient eligibility

About

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).

Full 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).

Enrollment: 173 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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173 participants in 3 patient groups, including a placebo group

Low-Carb Diet (LCHO)

Experimental group

Treatment:

Behavioral: Low-Carb diet

Mediterranean Diet (MeD)

Experimental group

Treatment:

Behavioral: Mediterranean diet

Control group

Placebo Comparator group

Treatment:

Behavioral: Standard Lifestyle Recommendations