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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2023
  • participants needed
    50
  • sponsor
    University of Aarhus
Updated on 26 May 2022
diabetes
oral glucose tolerance test
l-arginine

Summary

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.

Details
Condition Gestational Diabetes
Treatment Placebo, Whey
Clinical Study IdentifierNCT04856800
SponsorUniversity of Aarhus
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

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
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