Department of Internal Medicine, College of Medicine, Ewha Womans University, 1071 Anyangcheon-Ro, Yangcheon-Gu, Seoul, 07985, Republic of Korea.
Nutritional Science and Food Management, Ewha Womans University, Seoul, Republic of Korea.
Trials. 2023 Aug 2;24(1):490. doi: 10.1186/s13063-023-07444-4.
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. NAFLD can result in various complications. Owing to the lack of effective pharmacological therapies, lifestyle modifications are the cornerstone treatment for NAFLD. However, there has been no recommendation for a specific dietary therapy. Because no significant effects have been observed in previous studies. Intermittent calorie restriction (ICR) consists of alternating phases of extreme energy restriction and regular energy intake. Recent studies have demonstrated a significantly higher reduction in liver fat content in the ICR group than in the standard of care (SOC) or continuous calorie restriction groups in patients with NAFLD. However, critical weaknesses limit the broader application of ICR in clinical practice; those are a lack of appropriate assessment tools, different cutoffs of body mass index (BMI) used to define obesity, and different food portions. Thus, we report a protocol for a prospective, randomized controlled trial. The trial will evaluate the effect of 12-week ICR on improving liver fat content in NAFLD patients (Nonalcoholic Fatty Liver Disease-Intermittent Calorie Restriction [FLICR]).
We will include adult (19-75 years) NAFLD patients. NAFLD will be diagnosed by histologic assessment or magnetic resonance imaging-proton density fat fraction (MRI-PDFF) ≥ 8%. A total of 72 patients will be classified according to BMI (obese group: BMI ≥ 25 kg/m [n = 36] and non-obese group: BMI < 25 kg/m [n = 36]). Participants will be followed up for 24 weeks. Participants will be randomly assigned to one of the two groups: the SOC or ICR group. The primary objective will be the change in liver fat content measured using MRI-PDFF from baseline to 12 weeks.
This FLICR study may provide clinical evidence on ICR in the treatment of NAFLD in both obese and non-obese patients. The use of ICR in patients with NAFLD will improve the clinical outcomes of patients facing a shortage of effective medical therapy.
This trial was registered at the United States National Library of Medicine (NLM) at the National Institutes of Health.
gov NCT05309642. Registered on April 4, 2022.
非酒精性脂肪性肝病 (NAFLD) 是最常见的慢性肝病病因。NAFLD 可导致各种并发症。由于缺乏有效的药物治疗，生活方式改变是非酒精性脂肪性肝病的基石治疗方法。但是，尚未有针对特定饮食疗法的推荐。因为以前的研究没有观察到显著的效果。间歇性热量限制 (ICR) 由极端能量限制和常规能量摄入的交替阶段组成。最近的研究表明，与标准治疗 (SOC) 或连续热量限制组相比，NAFLD 患者的 ICR 组肝脂肪含量显著降低。然而，关键的弱点限制了 ICR 在临床实践中的更广泛应用；缺乏适当的评估工具、用于定义肥胖的不同体重指数 (BMI) 截止值以及不同的食物份量。因此，我们报告了一项前瞻性、随机对照试验的方案。该试验将评估 12 周 ICR 对改善 NAFLD 患者肝脂肪含量的影响（非酒精性脂肪性肝病-间歇性热量限制 [FLICR]）。
我们将纳入成年（19-75 岁）NAFLD 患者。NAFLD 将通过组织学评估或磁共振成像-质子密度脂肪分数 (MRI-PDFF)≥8%进行诊断。总共 72 名患者将根据 BMI 进行分类（肥胖组：BMI≥25kg/m [n=36] 和非肥胖组：BMI<25kg/m [n=36]）。参与者将随访 24 周。参与者将被随机分配到以下两个组之一：SOC 或 ICR 组。主要目标将是使用 MRI-PDFF 从基线到 12 周时肝脂肪含量的变化。
这项 FLICR 研究可能为肥胖和非肥胖患者的 ICR 治疗 NAFLD 提供临床证据。在 NAFLD 患者中使用 ICR 将改善面临有效药物治疗短缺的患者的临床结局。
本试验在美国国立卫生研究院 (NIH) 的美国国家医学图书馆 (NLM) 注册。
gov NCT05309642。于 2022 年 4 月 4 日注册。
