Faculty of Kinesiology, University of Calgary, 2500 University Drive NW, Calgary, AB, T2N 1N4, Canada.
Department of Biochemistry and Molecular Biology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Eur J Nutr. 2021 Apr;60(3):1237-1251. doi: 10.1007/s00394-020-02328-8. Epub 2020 Jul 8.
Soluble fibre beneficially affects metabolism but whether it can augment the reductions in glycemia induced through intensive weight management has not been extensively studied. Our objective was to examine the adjunct effect of the soluble viscous fibre PGX on glycemic control in adults with type 2 diabetes (T2D) enrolled in a year-long medically supervised weight management program.
In a placebo-controlled, double-blind study, 290 adults with overweight/obesity and T2D were randomized to receive PGX (15-20 g/day) or isocaloric placebo (rice flour, 6.4-8.6 g/day) as an adjunct to intensive weight management for 52 weeks. The primary outcome was change in glycemic control (HbA1c). Other outcome measures included weight loss, blood lipids, blood pressure, cytokines and fecal microbiota.
Compared to baseline HbA1c in PGX (7.2 ± 1.1%) and placebo (7.0 ± 0.9%) groups, there was a significant reduction at 16 and 26 weeks, however, only PGX showed a significant absolute reduction of 0.23% at 52 weeks; there were no between-group differences in HbA1c. At 52 weeks, only PGX significantly decreased body weight compared to baseline and reduced waist circumference at all time points. Compared to baseline, only PGX showed a significant reduction in LDL cholesterol at 16 and 26 weeks. PGX significantly increased the relative abundance of Collinsella, Parabacteroides and Roseburia.
Adding PGX to a weight management program for individuals with T2D provides a sustained reduction in HbA1c compared to placebo. Improvements in other metabolic outcomes suggest that PGX may be a promising adjunct to weight loss programs in patients with T2D.
This trial was registered at ClinicalTrials.gov as NCT01644201.
可溶性纤维有益于新陈代谢，但它是否能增强通过强化体重管理降低血糖的效果尚未得到广泛研究。我们的目的是研究在参加为期一年的医学监督体重管理计划的 2 型糖尿病（T2D）成人中，添加可溶性粘性纤维 PGX 对血糖控制的辅助作用。
在一项安慰剂对照、双盲研究中，将 290 名超重/肥胖和 T2D 成人随机分为 PGX（每天 15-20 克）或等热量安慰剂（米粉，每天 6.4-8.6 克）组，作为强化体重管理的辅助治疗，持续 52 周。主要结局是血糖控制的变化（HbA1c）。其他结局测量包括体重减轻、血脂、血压、细胞因子和粪便微生物群。
与 PGX（7.2±1.1%）和安慰剂（7.0±0.9%）组的基线 HbA1c 相比，16 和 26 周时有显著降低，但只有 PGX 在 52 周时显示出 0.23%的绝对降低；HbA1c 两组间无差异。在 52 周时，只有 PGX 与基线相比显著降低体重，并在所有时间点减少腰围。与基线相比，只有 PGX 在 16 和 26 周时显著降低 LDL 胆固醇。PGX 显著增加了 Collinsella、Parabacteroides 和 Roseburia 的相对丰度。
在 T2D 患者的体重管理计划中添加 PGX 可与安慰剂相比提供 HbA1c 的持续降低。其他代谢结局的改善表明，PGX 可能是 T2D 患者减肥计划的一种有前途的辅助手段。
该试验在 ClinicalTrials.gov 注册为 NCT01644201。
