魔芋纤维混合制剂与西洋参（Panax quinquefolius L.）联合应用对 2 型糖尿病患者血糖控制和血脂的影响：一项随机对照、交叉临床试验。
Co-administration of a konjac-based fibre blend and American ginseng (Panax quinquefolius L.) on glycaemic control and serum lipids in type 2 diabetes: a randomized controlled, cross-over clinical trial.
机构信息
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.
Department of Nutritional Sciences, School of Biosciences and Medicine, University of Surrey, Guildford, UK.
出版信息
Eur J Nutr. 2018 Sep;57(6):2217-2225. doi: 10.1007/s00394-017-1496-x. Epub 2017 Jul 7.
PURPOSE
Use of polypharmacy in the treatment of diabetes is the norm; nonetheless, optimal control is often not achieved. Konjac-glucomannan-based fibre blend (KGB) and American ginseng (AG) have individually been shown to improve glycaemia and CVD risk factors in type 2 diabetes. The aim of this study was to determine whether co-administration of KGB and AG could improve diabetes control beyond conventional treatment.
METHOD
Thirty-nine participants with type 2 diabetes (6.5 > A1c < 8.4%) were enrolled between January 2002 and May 2003 at the Risk Factor Modification Centre at St Michaels Hospital in a randomized, placebo-controlled, crossover trial with each intervention lasting 12-weeks. Medications, diet and lifestyle were kept constant. Interventions consisted of 6 g of fibre from KGB together with 3 g of AG (KGB and AG) or wheat bran-based, fibre-matched control. Primary endpoint was the difference in HbA1c levels at week 12.
RESULTS
Thirty participants (18M:12F; age: 64 ± 7 years; BMI: 28 ± 5 kg/m; HbA1c: 7.0 ± 1.0%) completed the study, and consumed 5.5 and 4.9 g/day of fibre from KGB and wheat bran control, respectively, and 2.7 g/day of AG. At week 12, HbA1c levels were 0.31% lower on the KGB and AG compared to control (p = 0.011). Mean (±SEM) plasma lipids decreased on the KGB and AG vs control by 8.3 ± 3.1% in LDL-C (p = 0.002), 7.5 ± 2.4% in non-HDL-C (p = 0.013), 5.7 ± 1.9% in total-C (p = 0.012), 4.1 ± 2.1% in total-C:HDL-C ratio (p = 0.042), 9.0 ± 2.3% in ApoB (p = 0.0005) and 14.6 ± 4.2% in ApoB:ApoA1 ratio (p = 0.049).
CONCLUSIONS
Co-administration of KGB and AG increases the effectiveness of conventional therapy through a moderate but clinically meaningful reduction in HbA1c and lipid concentrations over 12 weeks in patients with type 2 diabetes.
CLINICAL TRIALS REGISTRATION
NCT02806349 ( https://clinicaltrials.gov/ ).
目的
在治疗糖尿病时，联合使用多种药物是常规做法；尽管如此，通常仍无法达到理想的控制效果。基于葡甘露聚糖的纤维混合物（KGB）和西洋参（AG）已被证明可分别改善 2 型糖尿病患者的血糖和心血管疾病风险因素。本研究旨在确定联合使用 KGB 和 AG 是否可以改善常规治疗以外的糖尿病控制效果。
方法
2002 年 1 月至 2003 年 5 月期间，共有 39 名 2 型糖尿病患者（A1c＞6.5%且＜8.4%）在圣米迦勒医院的危险因素修正中心参与了这项随机、安慰剂对照、交叉试验，每个干预组持续 12 周。药物、饮食和生活方式保持不变。干预措施包括 6g 来自 KGB 的纤维与 3g AG（KGB 和 AG）或基于麦麸的纤维匹配对照物。主要终点是第 12 周时 HbA1c 水平的差异。
结果
共有 30 名参与者（18 名男性：12 名女性；年龄：64±7 岁；BMI：28±5kg/m；HbA1c：7.0±1.0%）完成了研究，并分别摄入了 5.5 和 4.9g/天的 KGB 和麦麸对照纤维，以及 2.7g/天的 AG。第 12 周时，与对照组相比，KGB 和 AG 组的 HbA1c 水平降低了 0.31%（p=0.011）。KGB 和 AG 组的 LDL-C（p=0.002）、非 HDL-C（p=0.013）、总胆固醇（p=0.012）、总胆固醇：HDL-C 比值（p=0.042）、ApoB（p=0.0005）和 ApoB：ApoA1 比值（p=0.049）分别降低了 8.3±3.1%、7.5±2.4%、5.7±1.9%、4.1±2.1%、9.0±2.3%和 14.6±4.2%。
结论
KGB 和 AG 的联合使用通过在 12 周内适度但具有临床意义地降低 HbA1c 和血脂浓度，增加了常规治疗的有效性，可改善 2 型糖尿病患者的治疗效果。
临床试验注册
NCT02806349（https://clinicaltrials.gov/）。
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