Central R&D Laboratory, Kobayashi Pharmaceutical Co., Ltd., Osaka, Japan.
Pharmaceutical Research and Technology Institute, Kindai University, Osaka, Japan.
J Med Food. 2021 Jan;24(1):10-17. doi: 10.1089/jmf.2020.4751. Epub 2020 Dec 23.
The number of diabetes mellitus and borderline diabetes cases is increasing and poses a serious problem worldwide. Plants of the genus are known to have α-glucosidase inhibitory activity and to lower postprandial hyperglycemia. Two randomized, double-blind, placebo-controlled clinical trials were conducted to evaluate the efficacy of extract. Study 1 was a single-dose crossover study of 150, 300, or 600 mg of extract or placebo to determine the dose dependency of the effect on postprandial hyperglycemia. The duration of the washout period between each experimental day was a minimum of 6 days. Study 2 was a 12-week, multiple-dose, parallel-group study to evaluate the effects of 600 mg/day of extract on blood glucose parameters. In Study 1, induced significant dose-dependent suppression of postprandial blood glucose, insulin, and their incremental area under the curve values. The dose of 600 mg appeared to have the most significant effect. In Study 2, significantly improved several blood glucose-related parameters, such as hemoglobin A1c, and glucose tolerance after glucose challenge. These results suggest that extract may have beneficial effects in patients with diabetes.
糖尿病和边缘性糖尿病的病例数量不断增加，这在全球范围内构成了一个严重的问题。已知属的植物具有α-葡萄糖苷酶抑制活性，并能降低餐后高血糖。进行了两项随机、双盲、安慰剂对照的临床试验，以评估提取物的疗效。研究 1 是一项单次剂量交叉研究，比较了 150、300 或 600mg 提取物或安慰剂对餐后高血糖的影响，以确定该作用的剂量依赖性。每次实验日之间的洗脱期至少为 6 天。研究 2 是一项为期 12 周、多剂量、平行组研究，评估了每天 600mg 提取物对血糖参数的影响。在研究 1 中，提取物能显著抑制餐后血糖、胰岛素及其增量曲线下面积，且呈剂量依赖性。600mg 的剂量效果似乎最为显著。在研究 2 中，提取物显著改善了糖化血红蛋白和葡萄糖耐量等与血糖相关的几个参数。这些结果表明，提取物可能对糖尿病患者有有益的影响。
