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槲皮素干预可减少非酒精性脂肪性肝病患者的肝脂肪沉积:一项随机、双盲、安慰剂对照交叉临床试验。

Quercetin intervention reduced hepatic fat deposition in patients with nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled crossover clinical trial.

机构信息

Department of Nutrition, Xinqiao Hospital, Army Medical University, Chongqing, China.

Department of Radiology, Xinqiao Hospital, Army Medical University, Chongqing, China.

出版信息

Am J Clin Nutr. 2024 Sep;120(3):507-517. doi: 10.1016/j.ajcnut.2024.07.013. Epub 2024 Jul 19.

Abstract

BACKGROUND

Nonalcoholic fatty liver disease (NAFLD) has become a growing public health problem worldwide. However, there is still lack of effective treatment strategies except lifestyle intervention.

OBJECTIVES

To evaluate whether quercetin improves intrahepatic lipid content in patients with NAFLD.

METHODS

In this randomized, double-blind, placebo-controlled crossover trial, 41 patients with NAFLD were randomly assigned to receive the quercetin (500 mg) or placebo capsules for 12 wk, then switched interventions for another 12 wk after a 4-wk washout period. The primary outcome was intrahepatic lipid content evaluated by magnetic resonance imaging estimated proton density fat fraction. The secondary outcomes were liver function measurements, etc. Safety outcomes included blood routine.

RESULTS

A total of 36 patients completed the trial. In intention-to-treat analyses, the quercetin intervention moderately decreased the intrahepatic lipid contents from 11.5% ± 6.4% to 9.6% ± 5.8%, compared with the placebo intervention (decreased by 0.1% ± 2.6%, P = 0.013 and adjusted P value is 0.028). Body weight and body mass index were mildly reduced by 1.5 ± 2.6 kg and 0.5 ± 0.9 kg/m after the quercetin intervention (P < 0.05 and both adjusted P values are 0.038), whereas the reductions were only 0.2 ± 1.8 kg and 0.1 ± 0.7 kg/m after the placebo intervention. The intrahepatic lipid content reductions were noticeably positively associated with the body weight losses after the quercetin and placebo interventions (r = 0.557 and 0.412, P < 0.001 and P = 0.007, respectively). Subgroup analyses found that the reduction of intrahepatic lipid contents in females (3.0% ± 3.7%) was about twice as large as that in males (1.4% ± 2.5%) with a trend of statistical significance (P = 0.113 and adjusted P value is 0.061). There were no significant differences in other secondary and safety outcomes. No adverse events associated with study intervention were found.

CONCLUSIONS

Twelve weeks treatment of quercetin could reduce intrahepatic lipid contents in patients with NAFLD, possibly explained by a slightly larger body weight loss in the quercetin group.

TRIAL REGISTRATION

The trial is registered at www.chictr.org.cn as ChiCTR2100047904.

摘要

背景

非酒精性脂肪性肝病(NAFLD)已成为全球日益严重的公共卫生问题。然而,除了生活方式干预外,仍然缺乏有效的治疗策略。

目的

评估槲皮素是否能改善 NAFLD 患者的肝内脂质含量。

方法

在这项随机、双盲、安慰剂对照的交叉试验中,41 名 NAFLD 患者被随机分配接受槲皮素(500mg)或安慰剂胶囊治疗 12 周,然后在 4 周洗脱期后再进行另 12 周的干预。主要结局是通过磁共振成像估计质子密度脂肪分数评估肝内脂质含量。次要结局包括肝功能测量等。安全性结局包括血常规。

结果

共有 36 名患者完成了试验。在意向治疗分析中,与安慰剂干预相比,槲皮素干预使肝内脂质含量从 11.5%±6.4%适度降低至 9.6%±5.8%(降低 0.1%±2.6%,P=0.013,调整 P 值为 0.028)。槲皮素干预后,体重和体重指数分别轻度下降 1.5±2.6kg 和 0.5±0.9kg/m2(P<0.05,两者的调整 P 值均为 0.038),而安慰剂干预后仅下降 0.2±1.8kg 和 0.1±0.7kg/m2。肝内脂质含量的降低与槲皮素和安慰剂干预后的体重减轻明显呈正相关(r=0.557 和 0.412,P<0.001 和 P=0.007)。亚组分析发现,女性(3.0%±3.7%)肝内脂质含量的降低大约是男性(1.4%±2.5%)的两倍,具有统计学意义的趋势(P=0.113,调整后的 P 值为 0.061)。其他次要和安全性结果无显著差异。未发现与研究干预相关的不良事件。

结论

12 周的槲皮素治疗可降低 NAFLD 患者的肝内脂质含量,这可能与槲皮素组体重减轻略多有关。

试验注册

该试验在中国临床试验注册中心注册,注册号为 ChiCTR2100047904。

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