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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral glucose tolerance test with whey protein pre-load | Experimental | 30 minutes prior to the 75 g OGTT, a whey protein solution is given. |
|
| Control oral glucose tolerance | No Intervention | 75 g OGTT without whey protein pre-load. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein-preload OGTT | Dietary Supplement | Intake of 25 g whey protein diluted in water 30 minutes prior to the start of a regular 75 g oral glucose tolerance test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose course | Course of plasma glucose assessed during a 75 g oral glucose tolerance test with vs without whey protein pre-load in pregnant women. | Timepoint 0-120 minutes during the oral glucose tolerance test. |
| Postprandial glucose excursion | 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. | Timepoint 0-120 minutes during the oral glucose tolerance test. |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin course | Course of insulin assessed during the 75 g oral glucose tolerance test in pregnant women. | Timepoint 0-120 minutes during the oral glucose tolerance test. |
| C-peptide course | Course C-peptide assessed during the 75 g oral glucose tolerance test in pregnant women. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin martin.heni@uniklinik-ulm.de, Prof. | University Hospital Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universityhospital Ulm | Ulm | 89081 | Germany |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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Each participant will undergo two oral glucose tolerance tests (i) one with whey protein pre-load and (ii) one without, in a randomized order.
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| Timepoint 0-120 minutes during the oral glucose tolerance test. |
| Insulin secretion | Insulin secretion assessed during the 75 g oral glucose tolerance test in pregnant women. | Timepoint 0-120 minutes during the oral glucose tolerance test. |
| Insulin sensitivity | Insulin sensitivity assessed during the 75 g oral glucose tolerance test in pregnant women. | Timepoint 0-120 minutes during the oral glucose tolerance test. |
| Glucagon course | Course of glucagon and area under the glucagon curve assessed during the 75 g oral glucose tolerance test in pregnant women. | Timepoint 0-120 minutes during the oral glucose tolerance test. |
| GLP-1 course | 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. | Timepoint 0-120 minutes during the oral glucose tolerance test. |
| GIP course | 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. | Timepoint 0-120 minutes during the oral glucose tolerance test. |
| Glicentin course | Course of glicentin and area under the glicentin curve assessed during the 75 g oral glucose tolerance test in pregnant women. | Timepoint 0-120 minutes during the oral glucose tolerance test. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |