Status:
COMPLETED
Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery
Lead Sponsor:
University of Aarhus
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 consu...
Eligibility Criteria
Inclusion
- GDM (OGTT level of blood glucose ≥ 9 mmol/L)
- Normal blood pressure
- Age \> 18 years
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04856800
Start Date
December 1 2021
End Date
October 31 2023
Last Update
December 12 2023
Active Locations (1)
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1
Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital
Aarhus, Denmark