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口服α-硫辛酸对超重或肥胖受试者体重的影响:一项交叉随机、双盲、安慰剂对照试验。

Effects of oral α-lipoic acid administration on body weight in overweight or obese subjects: a crossover randomized, double-blind, placebo-controlled trial.

作者信息

Li Nong, Yan Weili, Hu Xiaojuan, Huang Yongdi, Wang Fugang, Zhang Weiguo, Wang Qian, Wang Xiaoling, Sun Kehong

机构信息

Department of Endocrine and Metabolic Diseases, People's Hospital of Kelamay, Kelamay, Xinjiang, China.

Department of Clinical Epidemiology, Children's Hospital of Fudan University, Shanghai, China.

出版信息

Clin Endocrinol (Oxf). 2017 May;86(5):680-687. doi: 10.1111/cen.13303. Epub 2017 Feb 26.

Abstract

OBJECTIVE

Alpha-lipoic acid (ALA) has shown beneficial properties on diabetes and obesity. The aim of this study was to examine the effects of oral ALA on body weight in subjects with overweight or obese.

DESIGN

Single-centre, randomized, double-blind, crossover controlled study.

PARTICIPANTS

A total of 166 subjects of Chinese Han ethnicity with a BMI ≥25 kg/m were screened and 103 subjects fulfilled the study requirements, in terms of informed consent and participation to the study.

MEASUREMENTS

The subjects were randomized (1:1) to receive either ALA (1200 mg/day) or placebo treatment in a crossover design for 8 weeks. The primary end-point was the change in body weight. The secondary end-points were the changes in waist circumference, BMI, lipid profile, plasma leptin levels and the adverse events that occurred following ALA treatment.

RESULTS

The changes in the body weight and waist circumference noted in the ALA group were significantly different compared to the placebo group as demonstrated by mixed model statistical analysis (both P < 0·05). No real weight reduction was seen in the ALA group, and no significant differences were noted as regards cholesterol levels, triglyceride levels, high-density lipoprotein cholesterol levels and adverse events between the two groups. The administration of ALA was well tolerated, and no serious adverse events were noted.

CONCLUSIONS

Oral administration of ALA (1200 mg/day) for 8 weeks induced mild weight loss accompanied by a reduction in waist circumference.

摘要

目的

α-硫辛酸(ALA)已显示出对糖尿病和肥胖有益的特性。本研究的目的是检验口服ALA对超重或肥胖受试者体重的影响。

设计

单中心、随机、双盲、交叉对照研究。

参与者

共筛查了166名BMI≥25kg/m²的中国汉族受试者,103名受试者在签署知情同意书并参与研究方面符合研究要求。

测量

受试者按1:1随机分组,采用交叉设计接受ALA(1200mg/天)或安慰剂治疗8周。主要终点是体重变化。次要终点是腰围、BMI、血脂谱、血浆瘦素水平的变化以及ALA治疗后发生的不良事件。

结果

混合模型统计分析显示,ALA组的体重和腰围变化与安慰剂组相比有显著差异(均P<0.05)。ALA组未观察到实际体重减轻,两组在胆固醇水平、甘油三酯水平、高密度脂蛋白胆固醇水平和不良事件方面无显著差异。ALA的给药耐受性良好,未观察到严重不良事件。

结论

口服ALA(1200mg/天)8周可导致轻度体重减轻并伴有腰围减小。

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