MASLD
Conditions
Keywords
Hepatic disorders, MASLD, Nutrition intervention
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).
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: 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).
Interventions
BEHAVIORALLow-Carb diet
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.
BEHAVIORALMediterranean diet
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.
BEHAVIORALStandard Lifestyle Recommendations
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.
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Within- and between-group changes in hepatic steatosis [percentage, %] | 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] | 6 months | The unit of measure is decibels per meter (dB/m), as measured by transient elastography - FibroScan®. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in fat mass percentage | 6 months | Within- and between-groups changes in fat mass percentage measured by bioelectrical impedance analysis |
| Changes in energy expenditure. | 6 months | Within- and between-group changes in energy expenditure measured by indirect calorimetry. |
| Changes in insulin restistance [mmol/LxμU/mL] | 6 months | Within- and between-group changes in HOMA-IR \[mmol/LxμU/mL\] |
| Change in liver stiffness measured by transient elastography - FibroScan®. [kilopascals, kPa] | 6 months | Liver stiffness will be assessed using transient elastography - FibroScan®. |
| Changes in thrombospondin-2 (TSP2) [ng/ml] | 6 months | Assessing serum Thrombospondin-2 (TSP2) changes across incremental delta of weight loss |
| Changes in C-terminal procollagen 4 (PRO-C4) [ng/ml] | 6 months | Assessing serum C-terminal procollagen 4 (PRO-C4) changes across incremental delta of weight loss |
| Changes in serum transaminase levels | 6 months | Within- and between-group changes in serum transaminase levels \[U/L\] |
| Changes in fibrosis-4 index | 6 months | 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. |
Countries
Italy
Outcome results
None listed