Dowla Shima, Pendergrass May, Bolding Mark, Gower Barbara, Fontaine Kevin, Ashraf Ambika, Soleymani Taraneh, Morrison Shannon, Goss Amy
Department of Health Behavior, University of Alabama at Birmingham, Birmingham, AL, United States; School of Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.
Department of Nutrition, University of Alabama at Birmingham, Birmingham, AL, United States.
Contemp Clin Trials. 2018 May;68:95-101. doi: 10.1016/j.cct.2018.03.014. Epub 2018 Mar 27.
Non-alcoholic fatty liver disease (NAFLD) is the most common liver disorder among children in the developed world and can progress to cirrhosis, hepatocellular carcinoma, and liver failure. No evidence-based dietary guidelines exist on the most effective diet prescription to treat NAFLD.
To compare the effect of a carbohydrate (CHO)-restricted diet vs fat-restricted diet, the current standard of care, on changes in hepatic fat infiltration, body composition, and metabolic health over an 8-week period among overweight and obese children diagnosed with NAFLD.
In this two-arm, parallel design randomized controlled trial (RCT), 40 participants aged 9 to 18 years were randomized to a CHO restricted diet (<25:>50:25% daily calories from CHO: fat: protein) or control, fat restricted diet (55,20:25% daily calories from CHO: fat: protein). This family-based diet intervention included: (1) a 2-week supply of groceries to feed a four-person household specific to the assigned diet; and (2) extensive education on diet implementation through biweekly, diet-specific group and individualized counseling sessions with participants and one parent or guardian led by a registered dietitian (RD). The primary outcome measure of this study was hepatic lipid, measured using magnetic resonance spectroscopy (MRS). Secondary outcomes included liver transaminases; markers of inflammation (hsCRP, IL-6, TNF-α); body composition; visceral adipose tissue; and insulin resistance. All testing was conducted at baseline and week 8; hepatic transaminases were also measured at weeks 2 and 4. This RCT is registered with ClinicalTrials.gov (ID: NCT02787668).
非酒精性脂肪性肝病（NAFLD）是发达国家儿童中最常见的肝脏疾病，可进展为肝硬化、肝细胞癌和肝衰竭。目前尚无基于证据的饮食指南来指导治疗NAFLD的最有效饮食方案。
比较碳水化合物（CHO）限制饮食与脂肪限制饮食（当前的标准治疗方法）对超重和肥胖且诊断为NAFLD的儿童在8周内肝脏脂肪浸润、身体成分和代谢健康变化的影响。
在这项双臂、平行设计的随机对照试验（RCT）中，40名9至18岁的参与者被随机分配到CHO限制饮食组（每日热量中CHO：脂肪：蛋白质的比例<25:>50:25%）或对照组，即脂肪限制饮食组（每日热量中CHO：脂肪：蛋白质的比例为55:20:25%）。这种基于家庭的饮食干预包括：（1）提供为期2周的食品杂货，以满足四人家庭按照指定饮食的需求；（2）通过由注册营养师（RD）主持的每两周一次、特定饮食的小组和个性化咨询会议，对参与者及其一名家长或监护人进行广泛的饮食实施教育。本研究的主要结局指标是使用磁共振波谱（MRS）测量的肝脏脂质。次要结局包括肝转氨酶；炎症标志物（hsCRP、IL-6、TNF-α）；身体成分；内脏脂肪组织；以及胰岛素抵抗。所有检测均在基线和第8周进行；肝转氨酶在第2周和第4周也进行了测量。该RCT已在ClinicalTrials.gov注册（ID：NCT02787668）。
