在 2 型糖尿病患者中食用黄蜀葵(Abelmoschus esculentus(L.)Moench)的临床疗效和安全性:一项随机、双盲、安慰剂对照临床试验。
Clinical efficacy and safety of okra (Abelmoschus esculentus (L.) Moench) in type 2 diabetic patients: a randomized, double-blind, placebo-controlled, clinical trial.
机构信息
Department of Pharmacognosy, School of Pharmacy, Zanjan University of Medical Sciences, Zanjan, Iran.
Medicinal Plants Research Center, Maragheh University of Medical Sciences, Maragheh, Iran.
出版信息
Acta Diabetol. 2023 Dec;60(12):1685-1695. doi: 10.1007/s00592-023-02149-1. Epub 2023 Jul 28.
AIMS
The recent trend toward the use of natural functional and medical supplements has motivated the focus on the search and revival of traditional medicinal plant applications for many years. As a valuable dietary crop, okra fruit (Abelmoschus esculentus (L.) Moench) has been used for thousands of years as a medicinal food. This clinical trial aimed to assess the efficacy and safety of the okra pod capsule as an adjuvant treatment in controlling type 2 diabetes mellitus and provide clinical trial-based evidence about its anti-inflammatory effects.
METHODS
A total of 100 type II diabetic patients, aged between 40 and 60 years, were randomly assigned into two groups of okra and placebo. The first group was administered 1000 mg of powdered okra fruit three times a day for 3 months, while the other group received a placebo capsule with the same dosage. Both groups continued the standard antidiabetic therapy (consisting of metformin and gliclazide, as well as a nutritional regimen). At the start and three months later, various factors were measured, including FBG, insulin, HbA, cholesterol, triglycerides, HDL, LDL, CRP, liver and renal function tests, blood pressure, and BMI changes.
RESULTS
According to the results, patients who received okra treatment exhibited a significant decrease in FBG, HbA, total cholesterol, and triglyceride levels when compared to both the baseline and the placebo group. Patients in the okra group have lower levels of hs-CRP compared with the placebo group after 3 months of treatment. No liver, kidney, and blood pressure or other side effects were observed in the groups associated with okra treatment.
CONCLUSIONS
The present study demonstrated that adjunctive consumption of okra, in type 2 diabetic patients with 1000 mg three times a day for three months, improves lipid profile, glycemic control, and chronic inflammation without any tangible adverse effects.
CLINICAL TRIAL REGISTRY
IRCT.Ir (IRCT20120112008712N2). https://www.irct.ir/trial/42042 .
目的
近年来,人们对天然功能和药用补品的使用趋势不断增加,这促使人们多年来一直关注寻找和复兴传统药用植物的应用。秋葵果(Abelmoschus esculentus(L.)Moench)作为一种有价值的食用作物,几千年来一直被用作药用食品。本临床试验旨在评估秋葵荚胶囊作为辅助治疗 2 型糖尿病的疗效和安全性,并提供基于临床试验的抗炎作用证据。
方法
共有 100 名年龄在 40 至 60 岁之间的 2 型糖尿病患者被随机分为秋葵组和安慰剂组。第一组每天服用 1000 毫克粉末状秋葵果三次,持续 3 个月,而另一组则服用相同剂量的安慰剂胶囊。两组均继续进行标准的抗糖尿病治疗(包括二甲双胍和格列齐特以及营养方案)。在开始和三个月后,测量了各种因素,包括 FBG、胰岛素、HbA、胆固醇、甘油三酯、HDL、LDL、CRP、肝肾功能检查、血压和 BMI 变化。
结果
根据结果,与基线和安慰剂组相比,接受秋葵治疗的患者 FBG、HbA、总胆固醇和甘油三酯水平显著降低。与安慰剂组相比,秋葵组患者在治疗 3 个月后 hs-CRP 水平较低。与秋葵治疗相关的组未观察到肝、肾、血压或其他副作用。
结论
本研究表明,在 2 型糖尿病患者中,每天服用 1000 毫克秋葵三次,连续服用三个月,可以改善血脂谱、血糖控制和慢性炎症,而没有任何明显的不良影响。
临床试验注册号
IRCT.Ir(IRCT20120112008712N2)。[URL]