Whey Protein Pre-load and Postprandial Glycemia in Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Whey Protein on Postprandial Glucose Excursions in Pregnant Women

Conditions
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Pregnancy, Postprandial Glycemia

Intervention / Treatment
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* Dietary Supplement: Whey protein-preload OGTT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each participant will undergo two oral glucose tolerance tests (i) one with whey protein pre-load and (ii) one without, in a randomized order.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral glucose tolerance test with whey protein pre-load<br>30 minutes prior to the 75 g OGTT, a whey protein solution is given. | Dietary Supplement: Whey protein-preload OGTT<br>* Intake of 25 g whey protein diluted in water 30 minutes prior to the start of a regular 75 g oral glucose tolerance test<br>|
| No Intervention: Control oral glucose tolerance<br>75 g OGTT without whey protein pre-load. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin secretion, glycemia, postprandial glucose excursions, whey protein, protein pre-load, pregnancy, gestational diabetes mellitus, incretins