Does Soluble Fiber Supplementation Result in Lower Postprandial Blood Glucose in Women With Gestational Diabetes Compared With no Supplementation After a Standardized Breakfast? A Randomized, Controlled, Open-label, Prospective, Monocentric Clinical Cross-over Pilot Study at the Landesklinikum Mödling.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- postprandial blood glucose
研究概览
简要总结
The objective of this study is to investigate the effect of supplementation of 10g soluble fiber from guar on postprandial blood glucose levels in women with gestational diabetes after consumption of a standardized meal compared with no supplementation.
Null Hypothesis H0:
Soluble fiber supplementation will not result in a lower postprandial blood glucose increase in women with gestational diabetes compared to no supplementation after consumption of a standardized meal.
Alternative hypothesis H1:
Soluble fiber supplementation will result in a lower postprandial blood glucose increase in women with gestational diabetes compared to no supplementation after consumption of a standardized meal.
Study participants are randomly assigned to the intervention (consumption of a standardized meal and 10g soluble fibre) or control group (consumption of a standardized meal without soluble fibre). After a 2-day wash-out phase, the two groups are switched (the intervention group becomes the control group and vice versa) with the same standardized procedure.
详细描述
Background and study aims:
The effect of supplementation of soluble dietary fiber from guar in the form of a dietary food for special medical purposes (Optifibre©) on postprandial glucose levels in women with gestational diabetes after a standardized test meal (Resource cereal porridge©) was consumed with or without supplementation is being investigated.
The aim of this study is to verify whether the use of easily tolerated soluble dietary fiber in addition to nutritional therapy for gestational diabetes can lead to an improvement in glycemic control and thus represent a therapeutic option for diabetic diseases in the future.
Participants:
Women with gestational diabetes meeting the inclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with GDM by a pathological OGTT.
- •Second (13th to 28th week of pregnancy) and/or third trimester (29th to 40th week of pregnancy).
- •Sufficient knowledge of German to perform self-monitoring correctly
- •No intolerance to standardised meals (cereal porridge) or BST supplements
- •No concomitant disease requiring special dietary management
排除标准
- •Existing diabetes mellitus type 1 or type 2 in pregnancy
- •First trimester of pregnancy
- •Intolerance/contraindications to any of the ingredients of Resource cereal© or Optifibre©.
- •Insufficient language skills to perform self-monitoring
- •Insufficient language skills to adequately implement study procedure/intervention
结局指标
主要结局
postprandial blood glucose
时间窗: 4 days
postprandial blood glucose value in mg/dl with and without intervention
次要结局
- difference between fasting blood glucose value and postprandial blood glucose value(4 days)