基于卡路里限制饮食的综合生活方式干预可改善非酒精性脂肪肝的超重/肥胖患者的肝脏脂肪状况:中国多中心随机对照试验。

IF 4.4 2区 医学 Q1 NUTRITION & DIETETICS
Zhong Liu, Piaopiao Jin, Yuping Liu, Zhimian Zhang, Xiangming Wu, Min Weng, Suyan Cao, Yan Wang, Chang Zeng, Rui Yang, Chenbing Liu, Ping Sun, Cuihuan Tian, Nan Li, Qiang Zeng
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引用次数: 0

摘要

背景:非酒精性脂肪肝(NAFLD)是一种全球日益流行的疾病。生活方式干预被推荐为治疗非酒精性脂肪肝的主要方法。然而,最佳方法仍不明确。本研究旨在评估强化生活方式干预(ILI)的综合方法对中国超重和肥胖非酒精性脂肪肝患者肝脏脂肪变性和肝外代谢状况的影响:本研究是一项多中心随机对照试验(RCT),在中国七家医院进行。226名参与者的体重指数(BMI)超过25。这些参与者被随机分配到两组:ILI 组和对照组,前者采用低碳水化合物、高蛋白的 CRD,同时配合运动和营养师的强化辅导;后者采用均衡的 CRD,同时配合运动和标准辅导。研究的主要衡量指标是脂肪衰减参数(FAP)从研究开始到第 12 周的变化,并在按方案设定的范围内进行分析。次要衡量指标包括体重指数(BMI)的变化、肝脏硬度测量(LSM)以及各种代谢指标的改善情况。此外,还根据性别、年龄、体重指数、种族、高脂血症和高血压等变量对 FAP 进行了预先确定的亚组分析:共有 167 人完成了整个研究。与对照组相比,ILI 参与者的 FAP(LS 平均差值,16.07 [95% CI:8.90-23.25] dB/m)和 BMI(LS 平均差值,1.46 [95% CI:1.09-1.82] kg/m2)显著降低,但 LSM 改善幅度不大(LS 平均差值,0.20 [95% CI:-0.19-0.59] kPa)。ILI 还显著改善了其他次要结果(包括谷丙转氨酶、谷草转氨酶、谷草转氨酶、体脂质量、肌肉质量和骨骼肌质量、甘油三酯、空腹血糖、空腹胰岛素、HbA1c、HOMA-IR、HOMA-β、血压和同型半胱氨酸)。进一步的亚组分析表明,ILI 比对照干预能更显著地降低 FAP,尤其是在同时患有高血压的患者中(P 结论:ILI 比对照干预能更显著地降低 FAP,尤其是在同时患有高血压的患者中):在这项研究中,为期 12 周的强化生活方式干预计划显著改善了中国超重和肥胖非酒精性脂肪肝患者的肝脏脂肪变性和其他代谢指标。要证实这种方法的长期优势和实用性,还需要进一步的研究:本临床试验于2019年6月在ClinicalTrials.gov上注册(注册号:NCT03972631)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A comprehensive approach to lifestyle intervention based on a calorie-restricted diet ameliorates liver fat in overweight/obese patients with NAFLD: a multicenter randomized controlled trial in China.

Background: Nonalcoholic fatty liver disease (NAFLD) is a globally increasing health epidemic. Lifestyle intervention is recommended as the main therapy for NAFLD. However, the optimal approach is still unclear. This study aimed to evaluate the effects of a comprehensive approach of intensive lifestyle intervention (ILI) concerning enhanced control of calorie-restricted diet (CRD), exercise, and personalized nutrition counseling on liver steatosis and extrahepatic metabolic status in Chinese overweight and obese patients with NAFLD.

Methods: This study was a multicenter randomized controlled trial (RCT) conducted across seven hospitals in China. It involved 226 participants with a body mass index (BMI) above 25. These participants were randomly assigned to two groups: the ILI group, which followed a low carbohydrate, high protein CRD combined with exercise and intensive counseling from a dietitian, and a control group, which adhered to a balanced CRD along with exercise and standard counseling. The main measure of the study was the change in the fat attenuation parameter (FAP) from the start of the study to week 12, analyzed within the per-protocol set. Secondary measures included changes in BMI, liver stiffness measurement (LSM), and the improvement of various metabolic indexes. Additionally, predetermined subgroup analyses of the FAP were conducted based on variables like gender, age, BMI, ethnicity, hyperlipidemia, and hypertension.

Results: A total of 167 participants completed the whole study. Compared to the control group, ILI participants achieved a significant reduction in FAP (LS mean difference, 16.07 [95% CI: 8.90-23.25] dB/m) and BMI (LS mean difference, 1.46 [95% CI: 1.09-1.82] kg/m2) but not in LSM improvement (LS mean difference, 0.20 [95% CI: -0.19-0.59] kPa). The ILI also substantially improved other secondary outcomes (including ALT, AST, GGT, body fat mass, muscle mass and skeletal muscle mass, triglyceride, fasting blood glucose, fasting insulin, HbA1c, HOMA-IR, HOMA-β, blood pressure, and homocysteine). Further subgroup analyses showed that ILI, rather than control intervention, led to more significant FAP reduction, especially in patients with concurrent hypertension (p < 0.001).

Conclusion: In this RCT, a 12-week intensive lifestyle intervention program led to significant improvements in liver steatosis and other metabolic indicators in overweight and obese Chinese patients suffering from nonalcoholic fatty liver disease. Further research is required to confirm the long-term advantages and practicality of this approach.

Trial registration: This clinical trial was registered on ClinicalTrials.gov (registration number: NCT03972631) in June 2019.

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来源期刊
Nutrition Journal
Nutrition Journal NUTRITION & DIETETICS-
CiteScore
9.80
自引率
0.00%
发文量
68
审稿时长
4-8 weeks
期刊介绍: Nutrition Journal publishes surveillance, epidemiologic, and intervention research that sheds light on i) influences (e.g., familial, environmental) on eating patterns; ii) associations between eating patterns and health, and iii) strategies to improve eating patterns among populations. The journal also welcomes manuscripts reporting on the psychometric properties (e.g., validity, reliability) and feasibility of methods (e.g., for assessing dietary intake) for human nutrition research. In addition, study protocols for controlled trials and cohort studies, with an emphasis on methods for assessing dietary exposures and outcomes as well as intervention components, will be considered. Manuscripts that consider eating patterns holistically, as opposed to solely reductionist approaches that focus on specific dietary components in isolation, are encouraged. Also encouraged are papers that take a holistic or systems perspective in attempting to understand possible compensatory and differential effects of nutrition interventions. The journal does not consider animal studies. In addition to the influence of eating patterns for human health, we also invite research providing insights into the environmental sustainability of dietary practices. Again, a holistic perspective is encouraged, for example, through the consideration of how eating patterns might maximize both human and planetary health.
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