Wang Yiming, Yuan Huacai, Jiang Ruyue, Jia Keqing, Ding Xiaoping, Gu Ping, Sun Jianping
School of Public Health, Qingdao University, Qingdao, China.
Department of Clinical Nutrition, Qingdao Municipal Hospital, Qingdao, China.
Trials. 2025 Sep 24;26(1):349. doi: 10.1186/s13063-025-09080-6.
Accumulating evidence suggests that additional dietary fiber supplements may significantly improve glycolipid metabolism and pregnancy outcomes in individuals with gestational diabetes mellitus (GDM). However, the therapeutic effects of xylose oligosaccharides and inulin (XOS inulin) in pregnant women have not been investigated. Moreover, the underlying mechanism behind the therapeutic effects of this type of dietary fiber is not clear. Our study aims to assess the effects of daily XOS inulin supplementation on glycolipid metabolism and elucidate the therapeutic mechanism through gut microbiota analysis.
This study is an 8-week, parallel-design, open-label, three-arm, single-center randomized controlled trial. Eligible participants were pregnant women between 24 and 28 weeks of gestation, and they were diagnosed with GDM through an oral glucose tolerance test (OGTT). The participants in the three groups will receive nutrition education alone, nutrition education plus XOS inulin (XOS 2 g and inulin 10 g) 12 g/day, or nutrition education plus XOS inulin 24 g/day. Measurements will be taken at baseline, week 4, and week 8. The primary outcome will be the change in glycosylated serum protein (GSP), and the key secondary outcomes include changes in fasting glucose, fasting insulin (FINS), 2-h postprandial plasma glucose (2 h-PPG), HbA1c, total cholesterol (TC), triglycerides (TG), LDL cholesterol (LDL-C), HDL cholesterol (HDL-C), and changes in the gut microbiota.
This study will evaluate the therapeutic effects of XOS inulin supplementation on glycemic control, lipid metabolism, gastrointestinal function, and perinatal outcomes in GDM patients and their offspring. It also provides insight into the potential role of the gut microbiome as a target for enhancing the therapeutic efficacy of emerging treatments for GDM. All participants will receive comprehensive GDM nutrition education, promoting sustainable dietary modifications that optimize maternal metabolic health and fetal outcomes.
Chinese Clinical Trial registry ChiCTR2200060117. Registered on 19 May, 2022.
越来越多的证据表明，额外补充膳食纤维可能会显著改善妊娠期糖尿病（GDM）患者的糖脂代谢及妊娠结局。然而，低聚木糖和菊粉（XOS菊粉）对孕妇的治疗效果尚未得到研究。此外，这类膳食纤维治疗效果背后的潜在机制尚不清楚。我们的研究旨在评估每日补充XOS菊粉对糖脂代谢的影响，并通过肠道微生物群分析阐明其治疗机制。
本研究为一项为期8周的平行设计、开放标签、三臂、单中心随机对照试验。符合条件的参与者为妊娠24至28周的孕妇，她们通过口服葡萄糖耐量试验（OGTT）被诊断为GDM。三组参与者将分别接受单纯营养教育、营养教育加12克/天的XOS菊粉（低聚木糖2克和菊粉10克）或营养教育加24克/天的XOS菊粉。在基线、第4周和第8周进行测量。主要结局将是糖化血清蛋白（GSP）的变化，关键次要结局包括空腹血糖、空腹胰岛素（FINS）、餐后2小时血糖（2h-PPG）、糖化血红蛋白（HbA1c）、总胆固醇（TC）、甘油三酯（TG）、低密度脂蛋白胆固醇（LDL-C）、高密度脂蛋白胆固醇（HDL-C）的变化以及肠道微生物群的变化。
本研究将评估补充XOS菊粉对GDM患者及其后代血糖控制、脂质代谢、胃肠功能和围产期结局的治疗效果。它还深入探讨了肠道微生物群作为增强GDM新出现治疗方法疗效靶点的潜在作用。所有参与者都将接受全面的GDM营养教育，促进可持续的饮食调整，以优化母体代谢健康和胎儿结局。
中国临床试验注册中心ChiCTR2200060117。于2022年5月19日注册。
