Status:
COMPLETED
Acute Metabolic Effects of Pre-meal Consumption of Whey in Women at Risk of Gestational Diabetes Mellitus
Lead Sponsor:
University of Aarhus
Conditions:
Gestational Diabetes Mellitus in Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 consume...
Eligibility Criteria
Inclusion
- Referred to screening for Gestational Diabetes Mellitus by week 24-30 or GDM
- BMI 20-35
- 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
- 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
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04767880
Start Date
April 26 2021
End Date
September 29 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