Pilot trials of oral betaine in participants with metabolic dysfunction-associated steatotic liver disease and elevated alanine aminotransferase.

Our aim was to determine the safety and efficacy of lower doses of betaine in clinically diagnosed metabolic dysfunction-associated steatotic liver disease (MASLD) and an elevated ALT.

我们的目标是确定在临床诊断为代谢功能障碍相关脂肪性肝病（MASLD）和ALT升高患者中，较低剂量甜菜碱的安全性和有效性。

approach_and_results

We performed 3 pilot trials in participants with clinically diagnosed non-cirrhotic MASLD and ALT ≥50 U/L.

我们在临床上诊断为非肝硬化MASLD且ALT≥50 U/L的参与者中进行了3项初步试验。

In the first trial, 44 participants were randomized to 4 or 8 g daily for 12 weeks.

在第一项试验中，44名参与者被随机分配每天4克或8克，持续12周。

In the second trial, 10 participants received 1 g/day for 24 weeks, while 16 participants received 2 g/day for 24 weeks in the third trial. The primary outcome was the percent decline in the abnormal component of ALT (ie, ALT >30 for males or >25 for females).

在第二次试验中，10名参与者每天接受1克，持续24周，而在第三次试验中，16名参与者每天接受2克，持续24周。主要结果是ALT异常成分（即男性ALT>30或女性ALT>25）的百分比下降。

Other outcomes included improvement in absolute ALT and AST, and other serologic tests of liver injury, including metabolomics-advanced steatohepatitis fibrosis (MASEF) score, cytokeratin 18, and pro-C3.

其他结果包括绝对ALT和AST的改善，以及其他肝损伤的血清学测试，包括代谢组学高级脂肪性肝炎纤维化（MASEF）评分，细胞角蛋白18和前C3。

Baseline and end-of-treatment data were compared with a paired t test.

使用配对t检验比较基线和治疗结束时的数据。

At baseline, more than 75% of participants had NASH when tested by the MASEF score.

在基线时，通过MASEF评分测试，超过75%的参与者被诊断为非酒精性脂肪性肝炎（NASH）。

ALT, AST, cytokeratin 18, pro-C3, and MASEF score decreased significantly among participants receiving 8, 4​​​​​, and 2 g, but not 1 g.

接受8克、4克和2克剂量的参与者中，ALT、AST、细胞角蛋白18、pro-C3和MASEF评分显著下降，而接受1克剂量的参与者则没有。

High-density lipoprotein increased in the 4 and 2 g cohorts; low-density lipoprotein did not change.

4克和2克剂量组的高密度脂蛋白增加；低密度脂蛋白没有变化。

Approximately 35% reported mild, transient gastrointestinal symptoms.

约35%的受访者报告了轻度、短暂的胃肠道症状。

Conclusions

Betaine 8, 4​​​​​​, and 2 g/day for 12-24 weeks significantly reduced ALT and other serologic markers of liver injury among participants with clinically defined MASLD and an elevated ALT.

在临床定义的MASLD患者中，血清ALT升高者，每日8克、4克和2克的甜菜碱治疗12-24周，显著降低了ALT和其他肝损伤的血清标志物。