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一项随机、双盲、安慰剂对照的交叉临床试验,旨在评估钩葱提取物在糖尿病前期受试者中的抗糖尿病作用。

A randomized, double-blind, placebo-controlled crossover clinical trial to evaluate the anti-diabetic effects of Allium hookeri extract in the subjects with prediabetes.

机构信息

Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Republic of Korea.

Present address: Korea Food Research Institute, Wanju, Republic of Korea.

出版信息

BMC Complement Med Ther. 2020 Jul 6;20(1):211. doi: 10.1186/s12906-020-03005-3.

Abstract

BACKGROUND

Allium hookeri is widely consumed as a vegetable and herbal medicine in Asia. A. hookeri has been reported anti-inflammatory, anti-obesity, osteoblastic, anti-oxidant, and anti-diabetic effects in animal studies. We investigated the anti-diabetic effects of A. hookeri aqueous extract (AHE) in the Korean subjects.

METHODS

Prediabetic subjects (100 ≤ fasting plasma glucose (FPG) < 126 mg/dL) who met the inclusion criteria were recruited for this study. The enrolled subjects (n = 30) were randomly divided into either an AHE (n = 15, 486 mg/day) or placebo (n = 15) group. Outcomes were measurements of FPG, glycemic response to an oral glucose tolerance test (OGTT), insulin, C-peptide, hemoglobin A1c (HbA1c), total cholesterol, triglyceride, HDL-cholesterol, and LDL-cholesterol. The t-test was used to assess differences between the groups. A p-value < 0.05 was considered statistically significant.

RESULTS

Eight weeks after AHE supplementation, HbA1c level was significantly decreased in the AHE group compared with the placebo group. No clinically significant changes in any safety parameter were observed.

CONCLUSION

The findings suggest that AHE can be effective in reducing HbA1c, indicating it as an adjunctive tool for improving glycemic control.

TRIAL REGISTRATION

The study protocol was retrospectively registered at www.clinicaltrials.gov ( NCT03330366 , October 30, 2017).

摘要

背景

在亚洲,葱属钩状被广泛用作蔬菜和草药。动物研究表明,钩状葱具有抗炎、抗肥胖、成骨、抗氧化和抗糖尿病作用。我们研究了钩状葱水提物(AHE)对韩国受试者的抗糖尿病作用。

方法

符合纳入标准的糖尿病前期患者(100≤空腹血糖(FPG)<126mg/dL)被招募参加本研究。纳入的受试者(n=30)被随机分为 AHE 组(n=15,486mg/天)或安慰剂组(n=15)。结局测量包括 FPG、口服葡萄糖耐量试验(OGTT)的血糖反应、胰岛素、C 肽、糖化血红蛋白(HbA1c)、总胆固醇、甘油三酯、高密度脂蛋白胆固醇和低密度脂蛋白胆固醇。采用 t 检验评估组间差异。p 值<0.05 被认为具有统计学意义。

结果

AHE 补充 8 周后,AHE 组 HbA1c 水平明显低于安慰剂组。未观察到任何安全性参数的临床显著变化。

结论

研究结果表明,AHE 可有效降低 HbA1c,表明其可作为改善血糖控制的辅助工具。

试验注册

研究方案于 2017 年 10 月 30 日在 www.clinicaltrials.gov(NCT03330366)进行了回顾性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dfc/7339438/2ce84c7ded6d/12906_2020_3005_Fig1_HTML.jpg

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