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

NCT07304336 | Completed

• 1 other identifier: MASLD_DIET
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

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).

Conditions

MASLD

Keywords

Hepatic disorders; MASLD; Nutrition intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Change in liver stiffness measured by transient elastography - FibroScan®. [kilopascals, kPa]

  6 months

• Changes in fibrosis-4 index

  6 months

• Changes in fat mass percentage

  6 months

• Changes in energy expenditure.

  6 months

• Changes in insulin restistance [mmol/LxμU/mL]

  6 months

Study Arms (3)

Low-Carb Diet (LCHO)

EXPERIMENTAL

Behavioral: Low-Carb diet

Mediterranean Diet (MeD)

EXPERIMENTAL

Behavioral: Mediterranean diet

Control group

PLACEBO COMPARATOR

Behavioral: Standard Lifestyle Recommendations

Interventions

Low-Carb diet BEHAVIORAL

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.

Low-Carb Diet (LCHO)

Mediterranean diet BEHAVIORAL

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.

Mediterranean Diet (MeD)

Standard Lifestyle Recommendations BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

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

Torino, Torino, 10126, Italy

Location

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Diet, Mediterranean

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: December 26, 2025
• Study Start: February 10, 2022
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)