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

  • STATUS
    Recruiting
  • End date
    Oct 28, 2023
  • participants needed
    24
  • sponsor
    University of Aarhus
Updated on 28 May 2022
Accepts healthy volunteers

Summary

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.

Details
Condition Gestational Diabetes Mellitus in Pregnancy
Treatment Placebo, Whey
Clinical Study IdentifierNCT04767880
SponsorUniversity of Aarhus
Last Modified on28 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Referred to screening for Gestational Diabetes Mellitus by week 24-30
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
Clear my responses

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