Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Imaging Center, Nanfang Hospital, Southern Medical University, Guangzhou, China.
JAMA Netw Open. 2023 Mar 1;6(3):e233513. doi: 10.1001/jamanetworkopen.2023.3513.
The efficacy and safety of time-restricted eating (TRE) on nonalcoholic fatty liver disease (NAFLD) remain uncertain.
To compare the effects of TRE vs daily calorie restriction (DCR) on intrahepatic triglyceride (IHTG) content and metabolic risk factors among patients with obesity and NAFLD.
DESIGN, SETTING, AND PARTICIPANTS: This 12-month randomized clinical trial including participants with obesity and NAFLD was conducted at the Nanfang Hospital in Guangzhou, China, between April 9, 2019, and August 28, 2021.
Participants with obesity and NAFLD were randomly assigned to TRE (eating only between 8:00 am and 4:00 pm) or DCR (habitual meal timing). All participants were instructed to maintain a diet of 1500 to 1800 kcal/d for men and 1200 to 1500 kcal/d for women for 12 months.
The primary outcome was change in IHTG content measured by magnetic resonance imaging; secondary outcomes were changes in body weight, waist circumference, body fat, and metabolic risk factors. Intention-to-treat analysis was used.
A total of 88 eligible patients with obesity and NAFLD (mean [SD] age, 32.0 [9.5] years; 49 men [56%]; and mean [SD] body mass index, 32.2 [3.3]) were randomly assigned to the TRE (n = 45) or DCR (n = 43) group. The IHTG content was reduced by 8.3% (95% CI, -10.0% to -6.6%) in the TRE group and 8.1% (95% CI, -9.8% to -6.4%) in the DCR group at the 6-month assessment. The IHTG content was reduced by 6.9% (95% CI, -8.8% to -5.1%) in the TRE group and 7.9% (95% CI, -9.7% to -6.2%) in the DCR group at the 12-month assessment. Changes in IHTG content were comparable between the 2 groups at 6 months (percentage point difference: -0.2; 95% CI, -2.7 to 2.2; P = .86) and 12 months (percentage point difference: 1.0; 95% CI, -1.6 to 3.5; P = .45). In addition, liver stiffness, body weight, and metabolic risk factors were significantly and comparably reduced in both groups.
Among adults with obesity and NAFLD, TRE did not produce additional benefits for reducing IHTG content, body fat, and metabolic risk factors compared with DCR. These findings support the importance of caloric intake restriction when adhering to a regimen of TRE for the management of NAFLD.
ClinicalTrials.gov Identifiers: NCT03786523 and NCT04988230.
限时进食（TRE）对非酒精性脂肪性肝病（NAFLD）的疗效和安全性仍不确定。
比较 TRE 与每日热量限制（DCR）对肥胖和 NAFLD 患者肝内甘油三酯（IHTG）含量和代谢危险因素的影响。
设计、设置和参与者：这项 12 个月的随机临床试验纳入了来自中国广州南方医院的肥胖和 NAFLD 患者，于 2019 年 4 月 9 日至 2021 年 8 月 28 日进行。
肥胖和 NAFLD 患者被随机分配至 TRE（仅在 8：00 至 4：00 之间进食）或 DCR（习惯用餐时间）组。所有参与者均被指示在 12 个月内维持男性 1500 至 1800 千卡/天和女性 1200 至 1500 千卡/天的饮食。
主要结局是通过磁共振成像测量的 IHTG 含量变化；次要结局是体重、腰围、体脂和代谢危险因素的变化。采用意向治疗分析。
共有 88 名符合条件的肥胖和 NAFLD 患者（平均[标准差]年龄 32.0[9.5]岁；49 名男性[56%]；平均[标准差]体重指数 32.2[3.3]）被随机分配至 TRE（n=45）或 DCR（n=43）组。TRE 组的 IHTG 含量在 6 个月评估时降低了 8.3%（95%CI，-10.0%至-6.6%），DCR 组降低了 8.1%（95%CI，-9.8%至-6.4%）。TRE 组的 IHTG 含量在 12 个月评估时降低了 6.9%（95%CI，-8.8%至-5.1%），DCR 组降低了 7.9%（95%CI，-9.7%至-6.2%）。在 6 个月（差异百分比：-0.2；95%CI，-2.7 至 2.2；P=0.86）和 12 个月（差异百分比：1.0；95%CI，-1.6 至 3.5；P=0.45）时，两组之间的 IHTG 含量变化无差异。此外，两组的肝硬度、体重和代谢危险因素均显著且相当降低。
在肥胖和 NAFLD 成人中，与 DCR 相比，TRE 并没有在降低 IHTG 含量、体脂和代谢危险因素方面提供额外的益处。这些发现支持在遵守 TRE 方案治疗 NAFLD 时，热量摄入限制的重要性。
ClinicalTrials.gov 标识符：NCT03786523 和 NCT04988230。
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