Impacto de la Dieta Mediterránea Frente a la Dieta hipocalórica en la progresión de la Enfermedad hepática y el Riesgo Cardiovascular en Pacientes Con Enfermedad Hepática Metabólica Grasa. Búsqueda de Biomarcadores y Dianas terapéuticas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Steatosis response
研究概览
简要总结
Lifestyle interventions based on diet and physical activity are the cornerstone of management for metabolic dysfunction-associated steatotic liver disease (MASLD), yet individual responses remain highly variable. Advanced imaging biomarkers and genetic profiling may help to characterize response patterns. This study aimed to evaluate the impact of a Mediterranean diet-based lifestyle intervention, with or without structured physical activity, on liver steatosis and fibrosis assessed by magnetic resonance imaging, and to identify determinants of treatment response.
详细描述
This randomized controlled trial included adults with histologically confirmed metabolic dysfunction-associated steatotic liver disease (MASLD) recruited between June 2022 and February 2023 at two tertiary referral centres in Spain (Virgen del Rocío University Hospital, Seville, and University Hospital of Valladolid). Exclusion criteria included other causes of chronic liver disease, excessive alcohol intake (>20 g/day in women and >30 g/day in men) , inability to perform regular physical activity, current participation in other clinical trials, and use of steatogenic or investigational drugs.
At the screening visit, all patients received counselling to follow a Mediterranean diet enriched with extra virgin olive oil. Participants were then randomized 1:1 to a structured physical activity programme (exercise group) or to a control group receiving standard lifestyle recommendations during a 12-week active intervention period. Randomization was performed using a computer-generated sequence with concealed allocation. This was followed by a further 12-week observation phase without supervised intervention, with a total follow-up period of 24 weeks, designed to reflect real-life clinical practice.
The sample size was calculated based on the primary endpoint of steatosis improvement. Assuming an absolute difference of 30% between groups, with a two-sided α level of 0.05 and 80% power, a minimum of 36 patients per group was required. To account for an anticipated dropout rate of 20%, the target sample size was increased to 45 patients per group.
The study protocol was approved by the local ethics committees of both centres, and all participants provided written informed consent. The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with histologically confirmed metabolic dysfunction-associated steatotic liver disease (MASLD)
排除标准
- •Other causes of chronic liver disease
- •Excessive alcohol intake (>20 g/day in women and >30 g/day in men)
- •Inability to perform regular physical activity
- •Current participation in other clinical trials
- •Use of steatogenic or investigational drugs.
研究组 & 干预措施
Control
The control group was advised to perform moderate-intensity physical activity at home according to EASL recommendations
干预措施: At-home exercise plus Mediterranean diet (Behavioral)
Exercise
Supervised exercise programme consisting of moderate-intensity aerobic activity and resistance training three times per week at a sports centre.
干预措施: Exercise plus Mediterranean diet (Behavioral)
结局指标
主要结局
Steatosis response
时间窗: From baseline to week 24
Defined as a ≥30% reduction in MRI-proton density fat fraction (PDFF) from baseline to week 24
Fibrosis regression
时间窗: Frome baseline to week 24
≥20% reduction in liver stiffness measured by MRE or improvement of at least one fibrosis stage
次要结局
- % Change in Weight(From baseline to week 24)
- % Change in Waist Circumference(From baseline to week 24)
- % Change in Fat Mass(From baseline to week 24)
- % Change in Muscle Mass(From baseline to week 24)
- % Change in Fasting Triglycerides(From baseline to week 24)
- % Change in Fasting Aspartate Transaminase(From baseline to week 24)
- % Change in Fasting Alanine Transaminase(From baseline to week 24)
- % Change in Fasting Glycosylated Haemoglobin(From baseline to week 24)
- Change in Patient Reported Diet Habits by MEDAS Questionnaire(From baseline to week 24)
- Change in Patient Reported Diet Habits by Dietary Items Recount(From baseline to week 24)
- Change in Exercise Tolerance(From baseline to week 24)
- Change in Patient Reported Physical Activity(From baseline to week 24)
- Change in Patient Reported Individual Functioning(From baseline to week 24)
- Change in Patient Reported Quality of Life(From baseline to week 24)
- Genetic Analysis(At baseline)