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一项为期 8 周、随机、双盲、安慰剂对照的临床试验,旨在研究水解人参提取物的抗糖尿病作用。

An 8-wk, randomized, double-blind, placebo-controlled clinical trial for the antidiabetic effects of hydrolyzed ginseng extract.

机构信息

Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, 20 Geonji-ro, Deokjin-gu, Jeonju, Jeonbuk, Korea.

Clinical Trial Center, Chonbuk National University Hospital, 20 Geonji-ro, Deokjin-gu, Jeonju, Jeonbuk, Korea.

出版信息

J Ginseng Res. 2014 Oct 15;38(4):239-43. doi: 10.1016/j.jgr.2014.05.006. Epub 2014 May 23.

Abstract

BACKGROUND

To investigate the antidiabetic effects of hydrolyzed ginseng extract (HGE) for Korean participants in an 8-wk, randomized, double-blinded, placebo-controlled clinical trial.

METHODS

Impaired fasting glucose participants [fasting plasma glucose (FPG) ≥ 5.6mM or < 6.9mM] who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 23 participants were randomly divided into either the HGE (n = 12, 960 mg/d) or placebo (n = 11) group. Outcomes included measurements of efficacy (FPG, postprandial glucose, fasting plasma insulin, postprandial insulin, homeostatic model assessment-insulin resistance, and homeostatic model assessment-β) and safety (adverse events, laboratory tests, electrocardiogram, and vital signs).

RESULTS

After 8 wk of HGE supplementation, FPG and postprandial glucose were significantly decreased in the HGE group compared to the placebo group. No clinically significant changes in any safety parameter were observed. Our study revealed that HGE is a potent antidiabetic agent that does not produce noticeable adverse effects.

CONCLUSION

HGE supplementation may be effective for treating impaired fasting glucose individuals.

摘要

背景

在一项为期 8 周的随机、双盲、安慰剂对照临床试验中,研究水解人参提取物(HGE)对韩国参与者的降血糖作用。

方法

本研究招募了未被诊断出患有任何疾病且符合纳入标准的空腹血糖受损参与者[空腹血糖(FPG)≥5.6mM 或<6.9mM]。23 名参与者被随机分为 HGE(n=12,960mg/d)或安慰剂(n=11)组。结果包括疗效(FPG、餐后血糖、空腹血浆胰岛素、餐后胰岛素、稳态模型评估-胰岛素抵抗和稳态模型评估-β)和安全性(不良事件、实验室检查、心电图和生命体征)的测量。

结果

HGE 补充 8 周后,与安慰剂组相比,HGE 组的 FPG 和餐后血糖显著降低。未观察到任何安全性参数的临床显著变化。我们的研究表明,HGE 是一种有效的抗糖尿病药物,不会产生明显的不良反应。

结论

HGE 补充可能对治疗空腹血糖受损个体有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a5f0/4213818/9863a1148c87/gr1.jpg

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