Universityhospital Ulm
Ulm, 89081, Germany
NCT Number: NCT06170905
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Ulm, 89081, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intake of 25 g whey protein diluted in water 30 minutes prior to the start of a regular 75 g oral glucose tolerance test
Time frame: 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.
Time frame: 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.
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Course of insulin assessed during the 75 g oral glucose tolerance test in pregnant women.
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Course C-peptide assessed during the 75 g oral glucose tolerance test in pregnant women.
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Insulin secretion assessed during the 75 g oral glucose tolerance test in pregnant women.
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Insulin sensitivity assessed during the 75 g oral glucose tolerance test in pregnant women.
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Course of glucagon and area under the glucagon curve assessed during the 75 g oral glucose tolerance test in pregnant women.
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Course of glucagon-like peptide 1 (GLP-1) and area under the GLP-1 curve assessed during the 75 g oral glucose tolerance test in pregnant women.
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Course of glucose-dependent insulinotropic polypeptide (GIP) and area under the GIP curve assessed during the 75 g oral glucose tolerance test in pregnant women.
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Course of glicentin and area under the glicentin curve assessed during the 75 g oral glucose tolerance test in pregnant women.
University of Ulm
Other
Effect of Whey Protein on Postprandial Glucose Excursions in Pregnant Women
Acronym: ProGs
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