Department of Integrated Biomedical and Life Sciences, College of Health Science, Korea University, Seoul, Republic of Korea.
R&D Center, Koreaeundan Healthcare Co., Ansan-si, Gyeonggi-do, Republic of Korea.
J Med Food. 2020 Nov;23(11):1146-1154. doi: 10.1089/jmf.2019.4678. Epub 2020 Oct 2.
Many natural compounds have been reported to improve cognitive function in cell- and animal-based studies. In this clinical trial, we evaluated the efficacy of ethanolic extract of var. stem for improving cognitive function using a randomized, double-blind, placebo-controlled trial ( = 81) in aged people. After 12 weeks of administration of OFE (a mixture of ethanolic extract of var. stem and dextrin) or placebo, the effect on cognitive function was assessed. Overall, OFE did not show a significant difference from the placebo in terms of efficacy. However, the cognitive function significantly improved in the OFE group compared with the placebo group in the subgroup ≤70 years of age, which means that the effect of OFE administration exhibits an age-dependent effect. In addition, the safety of OFE was confirmed by analyzing blood test results, vital signs, and electrocardiograms. In conclusion, OFE administration in participants ≤70 years of age shows a positive effect on overall cognitive function. The trial was registered on CRIS (the Clinical Research Information Service), administered by the Korea Centers for Disease Control & Prevention (Registration Number: KCT0003766; URL: https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=12957).
许多天然化合物已被报道能改善细胞和动物基础研究中的认知功能。在这项临床试验中，我们使用随机、双盲、安慰剂对照试验（n=81）评估了 var. 茎的乙醇提取物改善认知功能的功效，该试验在老年人中进行。在给予 OFE（var. 茎的乙醇提取物和糊精的混合物）或安慰剂 12 周后，评估认知功能的效果。总体而言，OFE 在疗效方面与安慰剂没有显著差异。然而，与安慰剂组相比，OFE 组在≤70 岁的亚组中认知功能显著改善，这意味着 OFE 给药的效果表现出年龄依赖性。此外，通过分析血液检查结果、生命体征和心电图来确认 OFE 的安全性。总之，在≤70 岁的参与者中给予 OFE 显示出对整体认知功能的积极影响。该试验已在韩国疾病控制与预防中心（登记号：KCT0003766；网址：https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=12957）运营的 CRIS（临床研究信息服务）上注册。
