Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON, Canada.
Eur J Nutr. 2021 Sep;60(6):3071-3083. doi: 10.1007/s00394-020-02434-7. Epub 2021 Jan 24.
Viscous dietary fiber, functional seeds and ginseng roots have individually been proposed for the management of diabetes. We explored whether their co-administration would improve glycemic control in type 2 diabetes beyond conventional therapy.
In a randomized, double-blind, controlled trial conducted at two academic centers (Toronto, Canada and Zagreb, Croatia), individuals with type 2 diabetes were assigned to either an active intervention (10 g viscous fiber, 60 g white chia seeds, 1.5 g American and 0.75 g Korean red ginseng extracts), or energy and fiber-matched control (53 g oat bran, 25 g inulin, 25 g maltodextrose and 2.25 g wheat bran) intervention for 24 weeks, while on conventional standard of care. The prespecified primary endpoint was end difference at week 24 in HbA1c, following an intent-to-treat analysis adjusted for center and baseline.
Between January 2016 and April 2018, 104 participants (60M:44F; mean ± SEM age 59 ± 0.8 years; BMI 29.0 ± 0.4 kg/m; HbA1c 7.0 ± 0.6%) managed with antihyperglycemic agent(s) (n = 98) or lifestyle (n = 6), were randomized (n = 52 test; n = 52 control). At week 24, HbA1c levels were 0.27 ± 0.1% lower on test compared to control (p = 0.03). There was a tendency towards an interaction by baseline HbA1c (p = 0.07), in which a greater reduction was seen in participants with baseline HbA1c > 7% vs ≤ 7% (- 0.56 ± 0.2% vs 0.03 ± 0.2%). Diet and body weight remained unchanged. The interventions were well tolerated with no related adverse events and with high retention rate of 84%.
Co-administration of selected dietary and herbal therapies was well-tolerated and may provide greater glycemic control as add-on therapy in type 2 diabetes. Registration: Clinicaltrials.gov NCT02553382 (registered on September 17, 2015).
黏滞性膳食纤维、功能性种子和人参根各自被提议用于糖尿病的治疗。我们探索了它们的联合使用是否可以在常规治疗的基础上改善 2 型糖尿病患者的血糖控制。
在加拿大多伦多和克罗地亚萨格勒布的两个学术中心进行的一项随机、双盲、对照临床试验中，将 2 型糖尿病患者分配至活性干预组（10 克黏滞性膳食纤维、60 克白奇亚籽、1.5 克美国红参和 0.75 克韩国红参提取物）或能量和纤维匹配的对照组（53 克燕麦麸、25 克菊粉、25 克麦芽糊精和 2.25 克麦麸），同时接受常规标准护理，持续 24 周。基于意向治疗分析，根据中心和基线调整后，预先设定的主要终点为第 24 周时 HbA1c 的终点差值。
2016 年 1 月至 2018 年 4 月，在接受抗高血糖药物（n=98）或生活方式治疗（n=6）的 104 名参与者（60 名男性：44 名女性；平均年龄 59±0.8 岁；BMI 29.0±0.4 kg/m；HbA1c 7.0±0.6%）中，98 名参与者接受了随机分组（n=52 名试验组；n=52 名对照组）。在第 24 周时，试验组的 HbA1c 水平比对照组低 0.27±0.1%（p=0.03）。HbA1c 基线存在交互作用的趋势（p=0.07），在 HbA1c 基线>7%的参与者中，HbA1c 降低幅度更大（-0.56±0.2%比 0.03±0.2%）。饮食和体重保持不变。两种干预措施均耐受良好，无相关不良事件发生，保留率高达 84%。
选定的膳食和草药疗法联合使用耐受性良好，可能为 2 型糖尿病患者提供更好的血糖控制。注册：Clinicaltrials.gov NCT02553382（于 2015 年 9 月 17 日注册）。
