低糖饮食与常规饮食对青少年男性非酒精性脂肪肝的影响:一个随机对照临床研究

母婴        2019-09-07   来源:小豆子自媒体
Effect of a Low Free Sugar Diet vs Usual Diet on Nonalcoholic Fatty Liver Disease in Adolescent Boys: A Randomized Clinical Trial
低糖饮食与常规饮食对青少年男性非酒精性脂肪肝的影响:一个随机对照临床研究

来源:JAMA. 2019;321(3):256-265. doi:10.1001/jama.2018.20579

Key Points 关键点

Question Does restricting dietary free sugars reduce hepatic steatosis in children with nonalcoholic fatty liver disease?

问题:严格无糖饮食限制能否减少非酒精性脂肪肝儿童的肝脏脂肪变?

Findings  In this randomized clinical trial that included 40 adolescent boys aged 11 to 16 years with nonalcoholic fatty liver disease followed up for 8 weeks, provision of a diet low in free sugars compared with usual diet resulted in a greater reduction in hepatic steatosis from 25% to 17% in the low free sugar diet group and from 21% to 20% in the usual diet group, a statistically significant difference of −6.23% when adjusted for baseline.

发现:在这个随机对照临床研究中,纳入40例11-16岁非酒精性脂肪肝的青少年男性,随访8周。低糖饮食可将肝脏脂肪变性从25%降低至17%,而正常饮食只从21%降低至20%。使用基线校正后对比统计学差异为-6.23%。

Meaning  These preliminary findings suggest potential benefit of a diet low in free sugars for children with nonalcoholic fatty liver disease, but further research is needed to assess long-term and clinical outcomes.

意义:这些发现初步显示低糖饮食对非酒精性脂肪肝的儿童有潜在的益处,但是需要进一步的研究来评价长期和临床结局。

Abstract

Importance  Pediatric guidelines for the management of nonalcoholic fatty liver disease (NAFLD) recommend a healthy diet as treatment. Reduction of sugary foods and beverages is a plausible but unproven treatment.

重要性:儿童非酒精性脂肪肝(NAFLD)的管理指南推荐使用健康的饮食来治疗,减少含糖食物及饮料的摄入可能是一个有效但未被证实的措施。

Objective  To determine the effects of a diet low in free sugars (those sugars added to foods and beverages and occurring naturally in fruit juices) in adolescent boys with NAFLD.

目的:判断低糖饮食(这些糖分加入到食物和饮料中并出现在果汁中)对青少年NAFLD男性的影响。

Design, Setting, and Participants  An open-label, 8-week randomized clinical trial of adolescent boys aged 11 to 16 years with histologically diagnosed NAFLD and evidence of active disease (hepatic steatosis >10% and alanine aminotransferase level ≥45 U/L) randomized 1:1 to an intervention diet group or usual diet group at 2 US academic clinical research centers from August 2015 to July 2017; final date of follow-up was September 2017.

实验设计和研究对象:在一项开放标签,随访8周的随机对照研究中,选择2015年8月-2017年7月在2家美国学术临床研究中心的11-16岁病理诊断为NAFLD的青少年男性,且存在活动性病变的证据(肝脏脂肪变性>10%,ALT≥45U/L),按照1:1的比例分为干预饮食组和常规饮食组。随访截止时间为2017年9月。

Interventions  The intervention diet consisted of individualized menu planning and provision of study meals for the entire household to restrict free sugar intake to less than 3% of daily calories for 8 weeks. Twice-weekly telephone calls assessed diet adherence. 

Usual diet participants consumed their regular diet.

干预:干预饮食包括个体化菜单定制,以及为全部家庭提供研究膳食来严格限制糖分摄入,糖分摄入小于每天热量摄入的3%。每周两次电话随访评估饮食依从性。常规饮食组的研究对象使用平时规律饮食即可。

Main Outcomes and Measures  The primary outcome was change in hepatic steatosis estimated by magnetic resonance imaging proton density fat fraction measurement between baseline and 8 weeks. The minimal clinically important difference was assumed to be 4%. There were 12 secondary outcomes, including change in alanine aminotransferase level and diet adherence.

研究终点:主要终点为8周后与基线对比肝脏脂肪变性的改变(通过磁共振成像质子密度脂肪分数测量)。最小临床显著性差异为4%。有12个次要终点,包括ALT水平和饮食依赖性的改变。

Results  Forty adolescent boys were randomly assigned to either the intervention diet group or the usual diet group (20 per group; mean(SD) age, 13.0(1. 9)years; most were Hispanic 95%) and all completed the trial. The mean decrease in hepatic steatosis from baseline to week 8 was significantly greater for the intervention diet group (25% to 17%) vs the usual diet group (21% to 20%) and the adjusted week 8 mean difference was −6.23% (95% CI, −9.45% to −3.02%; P < .001). 

结果:40例青少年男性随机分为干预饮食组和常规饮食组(每组20例,平均年龄13±1.9岁,95%为白种人),所有患儿均完成研究。自基线开始随访8周后,干预饮食组(25% to 17%) 脂肪变性的平均下降率比常规饮食组(21% to 20%) 显著升高,校正后8周平均差异为−6.23% (95% CI, −9.45% to −3.02%; P <0 .001)。

Of the 12 prespecified secondary outcomes, 7 were null and 5 were statistically significant including alanine aminotransferase level and diet adherence. The geometric mean decrease in alanine aminotransferase level from baseline to 8 weeks was significantly greater for the intervention diet group (103 U/L to 61 U/L) vs the usual diet group (82 U/L to 75 U/L) and the adjusted ratio of the geometric means at week 8 was 0.65 U/L (95% CI, 0.53 to 0.81 U/L; P < .001). 

12个预先设置的次要终点中,7个无效,5个有显著性改变,包括ALT水平和饮食依从性的改变。自基线开始随访8周后,干预饮食组 (103 U/L to 61 U/L) 的ALT水平几何平均减少幅度明显高于常规饮食组(82 U/L to 75 U/L) ,8周时几何均数的校正比率为0.65 U/L (95% CI, 0.53 to 0.81 U/L; P < 0.001)。

Adherence to the diet was high in the intervention diet group (18 of 20 reported intake of <3% of calories from free sugar during the intervention). There were no adverse events related to participation in the study.

干预饮食组的饮食依从性明显升高(干预过程中,有18/20例报道糖分摄入小于总热量的3%)。研究中所有对象均未发生不良事件。

Conclusions and Relevance  In this study of adolescent boys with NAFLD, 8 weeks of provision of a diet low in free sugar content compared with usual diet resulted in significant improvement in hepatic steatosis. However, these findings should be considered preliminary and further research is required to assess long-term and clinical outcomes.

相关结论:在这个NAFLD青少年男性研究中,8周低糖饮食与常规饮食相比显著改善了肝脏脂肪变性。然而,这些发现应当考虑为初步发现,并需要进一步的研究来评价长期临床预后。


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