MASLDNCT07304336
Dietary Strategies for MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
A study testing Low-Carb diet, Mediterranean diet and Standard Lifestyle Recommendations in people with MASLD, run by University of Turin, Italy at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MASLD
- What is being tested?
- Low-Carb diet, Mediterranean diet and Standard Lifestyle Recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 1 siteItaly
- Study dates
- 10 Feb 2022to 24 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 and <75 years
- BMI ≥25 and <35 kg/m2
- not having previously received nutritional advice for the liver disease
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
AOU Città della Salute e della Scienza di Torino, University of Torino, Torino.
Torino, Torino, 10126
About this study
Official title: 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).
Read the 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:
- 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
- Being tested
- Low-Carb diet, Mediterranean diet, Standard Lifestyle Recommendations
- Keywords
- Hepatic disorders, MASLD, Nutrition intervention
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Carb dietBehavioural
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 dietBehavioural
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.
Standard Lifestyle RecommendationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-Carb Diet (LCHO) | Experimental | Not described Receives: Behavioral: Low-Carb diet |
| Mediterranean Diet (MeD) | Experimental | Not described Receives: Behavioral: Mediterranean diet |
| Control group | Placebo comparator | Not described Receives: Behavioral: Standard Lifestyle Recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®.
Measured: 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®.
Measured: 6 months
Secondary outcomes (8)
Change in liver stiffness measured by transient elastography - FibroScan®. [kilopascals, kPa]
Liver stiffness will be assessed using transient elastography - FibroScan®.
Measured: 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.
Measured: 6 months
Changes in fat mass percentage
Within- and between-groups changes in fat mass percentage measured by bioelectrical impedance analysis
Measured: 6 months
Changes in energy expenditure.
Within- and between-group changes in energy expenditure measured by indirect calorimetry.
Measured: 6 months
Changes in insulin restistance [mmol/LxμU/mL]
Within- and between-group changes in HOMA-IR [mmol/LxμU/mL]
Measured: 6 months
Changes in serum transaminase levels
Within- and between-group changes in serum transaminase levels [U/L]
Measured: 6 months
Changes in thrombospondin-2 (TSP2) [ng/ml]
Assessing serum Thrombospondin-2 (TSP2) changes across incremental delta of weight loss
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start10 Feb 2022
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona Bo, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304336
- Sponsor's protocol ID
- MASLD_DIET
- Status last verified
- Jan 2026
- First submitted
- 2 Oct 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Dietary Strategies in Managing Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07304336
- Acronym / sponsor ID
- MASLD_DIET
- Conditions
- MASLD
- Keywords
- Hepatic disorders, MASLD, Nutrition intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-Carb Diet (LCHO) | Experimental | Behavioral: Low-Carb diet |
| Mediterranean Diet (MeD) | Experimental | Behavioral: Mediterranean diet |
| Control group | Placebo comparator | Behavioral: Standard Lifestyle Recommendations |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥18 and <75 years
- BMI ≥25 and <35 kg/m2
- not having previously received nutritional advice for the liver disease
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Carb dietParticipants 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. | Behavioural | Low-Carb Diet (LCHO) |
| Mediterranean dietParticipants 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. | Behavioural | Mediterranean Diet (MeD) |
| Standard Lifestyle RecommendationsParticipants 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. | Behavioural | Control group |
Primary outcome
Within- and between-group changes in hepatic steatosis [percentage, %]
Time frame: 6 months
The unit of measure is the percentage (%) of liver fat content, as assessed by transient elastography - FibroScan®.
Within- and between-group changes in Controlled Attenuation Parameter. (CAP) [dB/m]
Time frame: 6 months
The unit of measure is decibels per meter (dB/m), as measured by transient elastography - FibroScan®.
8 secondary outcomes
Change in liver stiffness measured by transient elastography - FibroScan®. [kilopascals, kPa]
Time frame: 6 months
Changes in fibrosis-4 index
Time frame: 6 months
Changes in fat mass percentage
Time frame: 6 months
Changes in energy expenditure.
Time frame: 6 months
Changes in insulin restistance [mmol/LxμU/mL]
Time frame: 6 months
Changes in serum transaminase levels
Time frame: 6 months
Changes in thrombospondin-2 (TSP2) [ng/ml]
Time frame: 6 months
Changes in C-terminal procollagen 4 (PRO-C4) [ng/ml]
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for MASLD
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Enrolling by invitation
Effect of Ancestry Supplementation in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Carb diet, Mediterranean diet and Standard Lifestyle Recommendations in people with MASLD, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within- and between-group changes in hepatic steatosis [percentage, %] (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.