Gestational Diabetes Mellitus in Pregnancy
Conditions
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 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. The two study days in the laboratory will be repeated 3-9 months after pregnancy. The purpose of this is to be able to compare the metabolic response of pre-meal whey during pregnancy with the response in a not-pregnant state. The study days at home will not be repeated after pregnancy.
Interventions
DIETARY_SUPPLEMENTWhey
Doses of 10, 15, 20 and 30 gram protein of a regular whey protein compound (whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients))
DIETARY_SUPPLEMENTPlacebo
The placebo contains \<1 kcal and 0 g protein
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to the intervention and placebo in the laboratory setting. Quadruple (Participants, care providers, investigators and outcome assessors) Participants, care providers, investigators and outcome assessors will be blinded to the placebo and varying doses of whey in the home setting.
Intervention model description
Singleblind, randomized, crossover design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Referred to screening for Gestational Diabetes Mellitus by week 24-30 or GDM * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration differences in blood glucose following an OGTT | 3 hours following the OGTT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration differences in glucagon like peptide 1 (GLP-1) | 3 hours following the OGTT | — |
| Concentration differences in glucagon | 3 hours following the OGTT | — |
| Concentration differences in insulin | 3 hours following the OGTT | — |
| Concentration differences in c-peptide | 3 hours following the OGTT | — |
| Concentration differences in free fatty acids (FFA) | 3 hours following the OGTT | — |
| Concentration differences in ghrelin | 3 hours following the OGTT | — |
| Concentration differences in leptin | 3 hours following the OGTT | — |
| Concentration differences in amino acids (AA) | 3 hours following the OGTT | — |
| Concentration differences in glucose independent peptide (GIP) | 3 hours following the OGTT | — |
| Resting energy expenditure (REE) (Resting Metabolic Rate) | 3 hours following the OGTT | — |
| Respiratory quotient (RQ) | 3 hours following the OGTT | — |
| Self-reported appetite | 3 hours following the OGTT and 3 hours following breakfast | A visual analogue scale ranging from not at all to extremely will be used to assess Hunger, Fullness, Satiety, Desire, Prospective consumption (Quantity). |
| Heart rate | 5 days | A combined accelerometer and heart rate monitor will be used to measure heart rate (beats/minute) |
| Energy expenditure | 5 days | A combined accelerometer and heart rate monitor will be used to estimate energy expenditure (kCal) |
| Activity | 5 days | A combined accelerometer and heart rate monitor will be used to measure activity (counts/minute) |
| Continuous glucose measurements (CGM) | 5 days | Time in range, concentration differences in interstitial fluid glucose 3 hours following breakfast, glycemic variability, mean glucose, daily maximum glucose, estimated HbA1c |
| Gastric emptying rate (Concentration differences in blood paracetamol/acetaminophen) | 3 hours following the OGTT | — |
Countries
Denmark
Outcome results
None listed