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

University of Aarhus

Status: Completed

Conditions: Gestational Diabetes Mellitus in Pregnancy

Treatments: Dietary Supplement: Whey; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04767880

1-10-72-305-20

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups, including a placebo group

Whey

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Whey

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo