NCT07304336Completed
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
Source: ClinicalTrials.gov · Last updated 12 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 173 (actual)
- First submitted
- 2 Oct 2025
- Start date
- 10 Feb 2022
- Primary completion date
- 24 Feb 2025
- Lead sponsor
- University of Turin, Italy
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07304336
What you commit to
- Study type: Interventional
- Participants enrolled: 173
- From 10 Feb 2022 to the primary completion date, 24 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- pharmacological treatments potentially interfering with study outcomes (corticosteroids, glucagon-like-peptide 1 agonists, biologic drugs)
Other illness
- 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
Other
- pregnancy or breastfeeding
- inability to give written informed consent
- life expectancy expected to be \<1 year.
Who the study is looking for
- age ≥18 and \<75 years
- BMI ≥25 and \<35 kg/m2
- not having previously received nutritional advice for the liver disease
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AOU Città della Salute e della Scienza di Torino, University of Torino, Torino. Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.