Sun Xiaoyang, Li Fan, Yan Hongmei, Chang Xinxia, Yao Xiuzhong, Yang Xinyu, Wu Shasha, Suo Yue, Zhu Xiaopeng, Wang Chengyan, Gao Jian, Wang He, Chen Yan, Xia Mingfeng, Bian Hua, Gao Xin
Department of Endocrinology, Zhongshan Hospital, Fudan University, Shanghai, China; Institute of Metabolic Disease, Fudan University, Shanghai, China.
Department of Nutrition, Zhongshan Hospital, Fudan University, Shanghai, China.
Am J Clin Nutr. 2025 Jan;121(1):158-166. doi: 10.1016/j.ajcnut.2024.10.012. Epub 2024 Oct 22.
Calorie restriction has been demonstrated to be effective in treating metabolic dysfunction-associated steatotic liver disease (MASLD). However, it has been limited by poor long-term adherence.
This study aimed to compare intermittent calorie restriction (ICR) with traditional continuous calorie restriction (CCR) for the treatment of MASLD.
We conducted a 12-wk, parallel-arm, randomized controlled trial that included 60 adults with MASLD and abnormal glucose metabolism. The participants were randomly assigned to either the ICR group (2 successive days of fasting [∼500 kcal/d] and 5 d of recovery per week) or the CCR group. The primary outcome was liver fat content (LFC) measured by H-proton magnetic resonance spectroscopy. The secondary and exploratory outcomes included weight, body composition, glucose, insulin, lipids, and liver stiffness.
The mean reduction in LFC was -20.5% [95% confidence interval (CI): -25.0, -15.9%] in the ICR group and -15.5% (95% CI: -20.3, -10.8%) in the CCR group. Changes in LFC were not significantly different between the 2 groups (P = 0.15), and were homogeneous among different liver segments. The analysis of exploratory endpoints provided clues that the ICR was associated with greater reductions in fat mass and glycosylated hemoglobin. There were no significant differences in changes of weight, lean mass, insulin resistance, triglyceride, and liver stiffness between the 2 groups. Participants showed high adherence to both the ICR and CCR schemes.
The ICR and CCR schemes had similar effects on reducing LFC, suggesting that the ICR 5:2 diet can be an effective alternative for treating MASLD with high adherence.
This trial was registered at clinicaltrials.gov as NCT04283942.
热量限制已被证明对治疗代谢功能障碍相关脂肪性肝病（MASLD）有效。然而，长期依从性差限制了其应用。
本研究旨在比较间歇性热量限制（ICR）与传统的持续性热量限制（CCR）对MASLD的治疗效果。
我们进行了一项为期12周的平行双臂随机对照试验，纳入60名患有MASLD且糖代谢异常的成年人。参与者被随机分配至ICR组（每周连续2天禁食[约500千卡/天]，5天恢复进食）或CCR组。主要结局是通过氢质子磁共振波谱测量的肝脏脂肪含量（LFC）。次要结局和探索性结局包括体重、身体成分、血糖、胰岛素、血脂和肝脏硬度。
ICR组LFC的平均降低幅度为-20.5%[95%置信区间（CI）：-25.0，-15.9%]，CCR组为-15.5%（95%CI：-20.3，-10.8%）。两组间LFC的变化无显著差异（P = 0.15），且在不同肝段中具有同质性。探索性终点分析提示，ICR与更大幅度的脂肪量和糖化血红蛋白降低相关。两组间体重、去脂体重、胰岛素抵抗、甘油三酯和肝脏硬度的变化无显著差异。参与者对ICR和CCR方案均表现出高依从性。
ICR和CCR方案在降低LFC方面效果相似，表明ICR 5:2饮食可以成为治疗MASLD且依从性高的有效替代方案。
本试验在clinicaltrials.gov注册，注册号为NCT04283942。
