Whey Protein Pre-load and Postprandial Glycemia in Pregnancy (ProGs)

University of Ulm

Status

Completed

Conditions

Postprandial Glycemia

Pregnancy

Treatments

Dietary Supplement: Whey protein-preload OGTT

Study type

Interventional

Funder types

Other

Identifiers

NCT06170905

78/23

Details and patient eligibility

About

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.

Full description

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.

Enrollment

21 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.