Clinical Trial Center for Functional Foods, Jeonbuk National University Hospital, Jeonju, Jeonbuk, 54907, Republic of Korea.
Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, Jeonbuk, 54907, Republic of Korea.
Eur J Nutr. 2023 Apr;62(3):1415-1425. doi: 10.1007/s00394-022-03075-8. Epub 2023 Jan 11.
In our previous study, we showed that Lycium chinense Miller fruit extract (LFE) exerted hepatoprotective effects in mice. In the current study, we examined the effect of LFE on liver enzyme levels in subjects with mild hepatic dysfunction.
A total of 90 subjects, aged 19 to 70 years old, with abnormal alanine aminotransferase (ALT) levels, were randomly placed into either an LFE (n = 45) treatment group or a placebo group (n = 45). During the 12-week clinical trial, subjects in each group received either LFE or placebo capsules, and were instructed to take four tablets per day (1760 mg/day). The primary outcome of the study was the changes of ALT and γ-glutamyltransferase (GGT) levels in each subject. The safety of LFE supplementation was assessed and adverse events were recorded.
LFE supplementation for 12 weeks resulted in a significant reduction of ALT (P = 0.0498) and GGT (P = 0.0368) levels in comparison to the placebo. No clinically significant changes were observed in any safety parameters.
These results suggest that LFE can be applied to subjects with mild hepatic dysfunction with no possible side effects.
This study was registered at the Clinical Research Information Service (CRIS) as no. KCT0003985.
在我们之前的研究中,我们表明枸杞果实提取物(LFE)对小鼠具有保肝作用。在本研究中,我们研究了 LFE 对轻度肝功能障碍患者肝酶水平的影响。
共 90 名年龄在 19 至 70 岁之间的 ALT 水平异常的受试者被随机分为 LFE(n=45)治疗组或安慰剂组(n=45)。在 12 周的临床试验中,每组受试者分别服用 LFE 或安慰剂胶囊,并指导每天服用四片(1760mg/天)。该研究的主要结果是每位受试者 ALT 和γ-谷氨酰转移酶(GGT)水平的变化。评估了 LFE 补充剂的安全性并记录了不良反应。
与安慰剂相比,LFE 补充 12 周可显著降低 ALT(P=0.0498)和 GGT(P=0.0368)水平。未观察到任何安全参数有临床意义的变化。
这些结果表明,LFE 可应用于轻度肝功能障碍患者,无任何副作用。
本研究在临床研究信息服务(CRIS)中注册为 KCT0003985 号。