Division of Life Sciences, College of Life Sciences and Biotechnology, Korea University, Seoul, Republic of Korea.
R&D Center, Koreaeundan Healthcare Co., Ansan-si, Republic of Korea.
J Med Food. 2020 May;23(5):508-514. doi: 10.1089/jmf.2019.4513. Epub 2020 Mar 4.
extracts (AGE) reduced serum uric acid levels in hyperuricemia rats in several previous studies. However, its efficacy in human has not been yet explored. This study aimed at investigating the efficacy and safety of AGE on the anti-hyperuricemia effect in subjects with slightly high serum uric acid. A randomized, double-blinded, placebo-controlled clinical trial was conducted for 12 weeks. Eligible subjects were randomly assigned to either AGE (480 mg/day) or placebo. The primary endpoint was the change in serum uric acid concentrations from baseline to follow-up time points. The secondary endpoints were the change of serum xanthine oxidase activity, and the levels of C-reactive protein (CRP) and tumor necrosis factor alpha (TNF-) in the blood from baseline to follow-up time points. Safety was assessed by clinical laboratory parameters and adverse events reported by subjects. Six weeks of AGE supplementation significantly reduced serum uric acid level from baseline ( = .0468) but at the end of the intervention the participants did not show the beneficial effect of AGE supplementation. Also, the serum uric acid level in the AGE group was not significantly different at the follow-up time points, when compared with placebo. The mean changes of secondary endpoints from baseline to each time point did not show significant differences within and between the two groups. There were no adverse events reported by subjects or changes in safety parameters after intervention. In conclusion, AGE supplementation for 12 weeks did not show significant benefits for reducing serum uric acid concentrations in subjects with mild hyperuricemia.
在之前的几项研究中，提取物（AGE）可降低高尿酸血症大鼠的血清尿酸水平。然而，其在人类中的疗效尚未得到探索。本研究旨在研究 AGE 对血尿酸稍高的受试者抗高尿酸血症的疗效和安全性。进行了为期 12 周的随机、双盲、安慰剂对照临床试验。合格的受试者被随机分配到 AGE（480mg/天）或安慰剂组。主要终点是从基线到随访时间点血清尿酸浓度的变化。次要终点是血清黄嘌呤氧化酶活性的变化，以及从基线到随访时间点血液中 C 反应蛋白（CRP）和肿瘤坏死因子-α（TNF-）的水平的变化。安全性通过临床实验室参数和受试者报告的不良事件进行评估。AGE 补充 6 周可显著降低血清尿酸水平从基线（ = .0468）但在干预结束时，参与者没有表现出 AGE 补充的有益效果。此外，与安慰剂相比，AGE 组在随访时间点的血清尿酸水平没有显著差异。从基线到每个时间点的次要终点的平均变化在两组内和组间均无显著差异。干预后，受试者未报告不良事件或安全性参数发生变化。总之，AGE 补充 12 周对降低轻度高尿酸血症患者的血清尿酸浓度没有显著益处。
