Effects of soluble dietary fiber on glycolipid metabolism in gestational diabetes mellitus: study protocol for a randomized controlled clinical trial.

IF 2 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Trials Pub Date : 2025-09-24 DOI:10.1186/s13063-025-09080-6

Yiming Wang, Huacai Yuan, Ruyue Jiang, Keqing Jia, Xiaoping Ding, Ping Gu, Jianping Sun

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引用次数: 0

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: Chinese Clinical Trial registry ChiCTR2200060117. Registered on 19 May, 2022.

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可溶性膳食纤维对妊娠期糖尿病患者糖脂代谢的影响：一项随机对照临床试验的研究方案

背景：越来越多的证据表明，额外的膳食纤维补充剂可能显著改善妊娠期糖尿病（GDM）患者的糖脂代谢和妊娠结局。然而，低聚木糖和菊粉（XOS菊粉）对孕妇的治疗作用尚未研究。此外，这类膳食纤维治疗效果背后的潜在机制尚不清楚。本研究旨在通过肠道菌群分析，评估每日补充XOS菊粉对糖脂代谢的影响，并阐明其治疗机制。方法：本研究为8周、平行设计、开放标签、三组、单中心随机对照试验。符合条件的参与者为妊娠24 - 28周的孕妇，并通过口服葡萄糖耐量试验（OGTT）诊断为GDM。三组受试者分别接受单独的营养教育、营养教育加XOS菊粉（XOS 2 g +菊粉10 g） 12 g/d、营养教育加XOS菊粉24 g/d。测量将在基线、第4周和第8周进行。主要结局将是糖基化血清蛋白（GSP）的变化，关键的次要结局包括空腹血糖、空腹胰岛素（FINS）、餐后2小时血浆葡萄糖（2 h-PPG）、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）和肠道微生物群的变化。讨论：本研究将评估补充XOS菊粉对GDM患者及其后代的血糖控制、脂质代谢、胃肠功能和围产期结局的治疗效果。它还提供了肠道微生物组作为提高GDM新疗法治疗效果的靶点的潜在作用。所有参与者都将接受全面的GDM营养教育，促进可持续的饮食改变，优化母体代谢健康和胎儿结局。试验注册：中国临床试验注册中心ChiCTR2200060117。于2022年5月19日注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Trials 医学-医学：研究与实验

CiteScore

3.80

自引率

4.00%

发文量

966

审稿时长

6 months

期刊介绍： Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.