Comparing the Efficacy of Dietary Strategies in Managing Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Within- and between-group changes in hepatic steatosis [percentage, %]
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 and <75 years
- •BMI ≥25 and <35 kg/m2
- •not having previously received nutritional advice for the liver disease
排除标准
- •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.
结局指标
主要结局
Within- and between-group changes in hepatic steatosis [percentage, %]
时间窗: 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]
时间窗: 6 months
The unit of measure is decibels per meter (dB/m), as measured by transient elastography - FibroScan®.
次要结局
- Changes in serum transaminase levels(6 months)
- Changes in thrombospondin-2 (TSP2) [ng/ml](6 months)
- Change in liver stiffness measured by transient elastography - FibroScan®. [kilopascals, kPa](6 months)
- Changes in fat mass percentage(6 months)
- Changes in energy expenditure.(6 months)
- Changes in insulin restistance [mmol/LxμU/mL](6 months)
- Changes in C-terminal procollagen 4 (PRO-C4) [ng/ml](6 months)
- Change in liver stiffness measured by transient elastography - FibroScan®. [kilopascals, kPa](6 months)
- Changes in fat mass percentage(6 months)
- Changes in fibrosis-4 index(6 months)
- Changes in serum transaminase levels(6 months)
- Changes in energy expenditure.(6 months)
- Changes in insulin restistance [mmol/LxμU/mL](6 months)
- Changes in thrombospondin-2 (TSP2) [ng/ml](6 months)
- Changes in C-terminal procollagen 4 (PRO-C4) [ng/ml](6 months)
研究者
Simona Bo
Associate Professor, MD
University of Turin, Italy