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

University of Aarhus

Status: Completed

Conditions: Gestational Diabetes

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Whey

Study type: Interventional

Funder types: Other

Identifiers

NCT04856800

1-10-72-326-20

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Whey

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Whey

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo