Effect of Whey Protein on Postprandial Glucose Excursions in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Postprandial glucose excursion
研究概览
简要总结
This pilot study aims to investigate the intake of whey protein prior to carbohydrate intake as an approach to modulate postprandial glucose excursions during pregnancy.
详细描述
Gestational diabetes (GDM) has transgenerational health consequences and increases the risk of type 2 diabetes mellitus in both mother and child. However, there is a lack of practical nutritional concepts for the prevention and treatment of GDM. This randomized controlled pilot study investigates whether the intake of a protein drink before carbohydrate intake lowers postprandial blood glucose levels of pregnant women. Therefore, two 75g oral glucose tolerance tests are performed in 20 pregnant women in a cross-over design, whereby a whey protein solution is drunk 30 minutes before one of the oral glucose tolerance tests (OGTT). If a clinically relevant effect on blood glucose levels is identified, this project can clarify whether the reduction in postprandial glycemia was caused by changes in the secretion of insulin and incretins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women between 24+0 and 27+6 (+/- 7 days) weeks of pregnancy after menstruation
- •BMI before pregnancy: 18 - 29.9 kg/m2
- •No known underlying diseases
- •Understanding and voluntary signing of a consent form before study-related examinations
排除标准
- •Age < 18 years
- •Diabetes mellitus type 1 or type 2
- •Drug therapy that raises or lowers blood sugar, e.g. steroids, antidiabetics, insulin.
- •Endocrine disorders (e.g. hyperthyroidism, polycystic ovary syndrome (PCOS), ...)
- •Current depression or other mental illnesses
- •Eating disorder
- •Regular intake of medication other than vitamins/trace elements during pregnancy
- •Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m²
- •C-reactive protein > 10 mg/l
- •Transaminase elevation of 2 times the upper norm
- •Pre-existing cardiac diseases
- •Drug and/or alcohol abuse
- •Hb < 12 g/dl
- •No consent to be informed about incidentally discovered pathological findings
- •Any other (clinical) condition that would endanger participants safety or question scientific success according to the physicians opinion.
研究组 & 干预措施
Oral glucose tolerance test with whey protein pre-load
30 minutes prior to the 75 g OGTT, a whey protein solution is given.
干预措施: Whey protein-preload OGTT (Dietary Supplement)
Control oral glucose tolerance
75 g OGTT without whey protein pre-load.
结局指标
主要结局
Postprandial glucose excursion
时间窗: Timepoint 0-120 minutes during the oral glucose tolerance test.
Area under the glucose curve (AUC 0-30 Min. and AUC 0-120 Min.) and peak glucose assessed during a 75 g oral glucose tolerance test with vs without whey protein pre-load in pregnant women.
Glucose course
时间窗: Timepoint 0-120 minutes during the oral glucose tolerance test.
Course of plasma glucose assessed during a 75 g oral glucose tolerance test with vs without whey protein pre-load in pregnant women.
次要结局
- Glucagon course(Timepoint 0-120 minutes during the oral glucose tolerance test.)
- GLP-1 course(Timepoint 0-120 minutes during the oral glucose tolerance test.)
- Insulin course(Timepoint 0-120 minutes during the oral glucose tolerance test.)
- C-peptide course(Timepoint 0-120 minutes during the oral glucose tolerance test.)
- GIP course(Timepoint 0-120 minutes during the oral glucose tolerance test.)
- Glicentin course(Timepoint 0-120 minutes during the oral glucose tolerance test.)
- Insulin secretion(Timepoint 0-120 minutes during the oral glucose tolerance test.)
- Insulin sensitivity(Timepoint 0-120 minutes during the oral glucose tolerance test.)
研究者
Martin Heni
Prof. Martin Heni
University of Ulm