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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Carb Diet (LCHO) | Experimental |
| |
| Mediterranean Diet (MeD) | Experimental |
| |
| Control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in liver stiffness measured by transient elastography - FibroScan®. [kilopascals, kPa] | Liver stiffness will be assessed using transient elastography - FibroScan®. | 6 months |
| Changes in fibrosis-4 index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Città della Salute e della Scienza di Torino, University of Torino, Torino. | Torino | Torino | 10126 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 20, 2021 | Dec 11, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| 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. |
|
| 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. |
|
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.
| 6 months |
| Changes in fat mass percentage | Within- and between-groups changes in fat mass percentage measured by bioelectrical impedance analysis | 6 months |
| Changes in energy expenditure. | Within- and between-group changes in energy expenditure measured by indirect calorimetry. | 6 months |
| Changes in insulin restistance [mmol/LxμU/mL] | Within- and between-group changes in HOMA-IR [mmol/LxμU/mL] | 6 months |
| Changes in serum transaminase levels | Within- and between-group changes in serum transaminase levels [U/L] | 6 months |
| Changes in thrombospondin-2 (TSP2) [ng/ml] | Assessing serum Thrombospondin-2 (TSP2) changes across incremental delta of weight loss | 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 | 6 months |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |