Acute Metabolic Effects of Pre-meal Consumption of Whey in Women at Risk of Gestational Diabetes Mellitus

Acute Metabolic Effects of Pre-meal Consumption of Whey in Women at Risk of Gestational Diabetes Mellitus

Acute Metabolic Effects of Pre-meal Consumption of Whey in Women at Risk of Gestational Diabetes Mellitus

The main objective of our study is to investigate the metabolic effects of whey protein (whey protein isolate, WPI, (Lacprodan® ISO.Water. from Arla Foods Ingredients) compared to placebo when consumed by women in risk of gestational diabetes mellitus (GMD) 30 minutes prior to an oral glucose tolerance test (OGTT). We will also investigate any changes in substrate metabolism and energy expenditure using indirect calorimetry. Differences in hunger and satiety parameters as well as rate of gastric emptying will also be assessed. Furthermore, we will investigate the glucose response when the women consume the intervention at home in their own environment 30 minutes before breakfast in various doses (placebo, 10, 15, 20, 30 g whey). The women will be monitored with continuous glucose monitors, activity monitors and all meals will be provided. The two study days in the laboratory will be repeated 3-9 months after pregnancy. The purpose of this is to be able to compare the metabolic response of pre-meal whey during pregnancy with the response in a not-pregnant state. The study days at home will not be repeated after pregnancy.

Participants will be blinded to the intervention and placebo in the laboratory setting. Quadruple (Participants, care providers, investigators and outcome assessors) Participants, care providers, investigators and outcome assessors will be blinded to the placebo and varying doses of whey in the home setting.

Whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients). The intervention will be ingested 30 min. prior to an OGTT (3 hours). The intervention will also be ingested 30 min prior to breakfast in the women's own environment.

The placebo will be ingested 30 min. prior to an OGTT (3 hours). The placebo will also be ingested 30 min prior to breakfast in the women's own environment.

Doses of 10, 15, 20 and 30 gram protein of a regular whey protein compound (whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients))

A visual analogue scale ranging from "not at all" to "extremely" will be used to assess Hunger, Fullness, Satiety, Desire, Prospective consumption (Quantity).

Time in range, concentration differences in interstitial fluid glucose 3 hours following breakfast, glycemic variability, mean glucose, daily maximum glucose, estimated HbA1c

Inclusion Criteria: Referred to screening for Gestational Diabetes Mellitus by week 24-30 or GDM BMI 20-35 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 Celiac disease Medication with effect on glucose metabolism e.g. steroid Do not speak or understand Danish Gemelli Polycystic Ovarian Syndrome PI finds the patient unfit (like mental illness, too nervous or other) Anemia (hemoglobin <6 mmol/l) Severe chronic illness Depression Severe nausea/vomiting Non-breakfast eaters

Institute of Clinical Medicine, Aarhus University and Department of Gynecology and Obstetrics and Steno Diabetes Center Aarhus, Aarhus University Hospital

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