余甘子对健康人体的临床评估:一项随机、双盲、交叉、安慰剂对照研究的健康益处与安全性结果

Clinical evaluation of Emblica Officinalis Gatertn (Amla) in healthy human subjects: Health benefits and safety results from a randomized, double-blind, crossover placebo-controlled study.

作者信息

Kapoor Mahendra Parkash, Suzuki Koji, Derek Timm, Ozeki Makoto, Okubo Tsutomu

机构信息

Taiyo Kagaku Co. Ltd., Nutrition Division, 1-3 Takaramachi, Yokkaichi, Mie, 510-0844, Japan.

Department of Molecular Pathobiology, Mie University, 2-174 Edobashi, Tsu City, Mie, 514 8507, Japan.

出版信息

Contemp Clin Trials Commun. 2019 Nov 27;17:100499. doi: 10.1016/j.conctc.2019.100499. eCollection 2020 Mar.

Abstract

The preventive efficacies and safety of (Amla), a most important and extensively studied plant in the traditional Indian Ayurvedic system of medicine, are presented. Eligible healthy adult subjects (n = 15) were randomized to receive either amla or placebo (500 mg per day) during an 18-week study. The efficacy parameters evaluated were the vascular function, blood hematology, oxidative and inflammatory biomarkers, glucose and lipid profiles, urinalysis, and liver hepatotoxicity. The amla intake showed significant improvements in the primary efficacy parameter of blood fluidity. There were also improvements in the secondary endpoints including lowering of von Willebrand factor (vWF), reduced 8-hydroxy-2'-deoxyguanosine (8-OHdG) as well as thrombin (TM) biomarkers of oxidative stress along with a significant improvement in HDL-cholesterol and lowering the LDL-cholesterol levels. No substantial changes were observed in liver hepatotoxicity, urinalysis, and hematology after consumption of amla compared to baseline or placebo. In addition, no adverse events, changes safety parameters or tolerance issues were observed after consumption of amla. In conclusion, amla supplementation showed acceptable palatability, improved endothelial functions and reduced oxidative stress.

摘要

介绍了印度传统阿育吠陀医学体系中一种最重要且研究广泛的植物——余甘子的预防功效和安全性。在一项为期18周的研究中,符合条件的健康成年受试者(n = 15)被随机分为两组,分别接受余甘子或安慰剂(每日500毫克)。评估的功效参数包括血管功能、血液学、氧化和炎症生物标志物、血糖和血脂谱、尿液分析以及肝脏肝毒性。摄入余甘子后,血液流动性这一主要功效参数有显著改善。次要终点指标也有改善,包括血管性血友病因子(vWF)降低、氧化应激的生物标志物8-羟基-2'-脱氧鸟苷(8-OHdG)以及凝血酶调节蛋白(TM)减少,同时高密度脂蛋白胆固醇显著改善,低密度脂蛋白胆固醇水平降低。与基线或安慰剂相比,食用余甘子后肝脏肝毒性、尿液分析和血液学未观察到实质性变化。此外,食用余甘子后未观察到不良事件、安全参数变化或耐受性问题。总之,补充余甘子显示出可接受的适口性,改善了内皮功能并减少了氧化应激。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/68a8/6926135/da98d01e479d/gr1.jpg

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