Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery

The main objective of the study is to investigate the metabolic effects of whey protein (whey protein isolate, WPI, (Lacprodan® ISO.Water. from Arla Foods Ingredients) compared with placebo when consumed by women with gestational diabetes mellitus (GDM) from diagnosis (around gestational week 28) to delivery. Any changes in substrate metabolism and energy expenditure using indirect calorimetry will also be investigated. Differences in hunger and satiety parameters as well as blood pressure and gestational weight gain will also be assessed. Furthermore, analysis on the glucose response when the women consume the intervention (whey or placebo) at home in their own environment 30 minutes before breakfast at time of diagnosis (earliest week 28) and week 36 (four days following each time point) will be made. The women will be monitored with continuous glucose monitors, activity monitors and all meals will be provided for two days following the study days in the laboratory. At delivery cord blood will be sampled for analysis on metabolic parameters and investigations on epigenetics/DNA methylations. Complications to the delivery, neonatal outcomes, anthropometrics of the child will also be assessed. Breast milk composition will also be analyzed.

Whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients). 20 g of whey protein will be ingested 30 min. prior to breakfast from diagnosis of GDM (around week 28) and until delivery.

The placebo will be ingested 30 min. prior to breakfast from diagnosis of GDM (around week 28) and until delivery.

Questionnaire: A numerical rating scale ranging from "not at all = 0" to "extremely = 10" will be used to assess Hunger, Fullness, Satiety, Desire, Prospective consumption (Quantity).

number of participants prescribed insulin, dose of insulin, time to insulin. Methyldopa, nifidipin or labetalol (medication to lower blood pressure)

Non-targeted metabolomics will be performed on a sample of breast milk using Nuclear Magnetic Resonance

Analysis generating metabolites from pathways on amino acids, peptides, carbohydrates and lipids measured in folds increase/decrease when comparing placebo with whey

Measurement of acidity of the blood. Standard measurement performed on a sample of cord blood when a baby is delivered to evaluate possible oxygen deficiency during delivery.

Analysis generating metabolites from pathways on amino acids, peptides, carbohydrates, lipids and energy measured in folds rise/fall in when comparing placebo with whey

Inclusion Criteria: GDM (OGTT level of blood glucose ≥ 9 mmol/L) Normal blood pressure Age > 18 years Exclusion Criteria: Special dietary regimes > 1 month at time of inclusion e.g. ketogenic diet Daily intake of protein supplements Milk allergy or phenylketonuria Medication with effect on glucose metabolism e.g. steroids Do not speak or understand Danish Twin pregnancy PCOS PI finds the patient unfit (like mental illness, too nervous or other) Severe chronic illness Severe nausea/vomiting Non-breakfast eaters Celiac disease The initiation of insulin treatment during the trial will not lead to exclusion from the trial.

Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital