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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Dietary Supplement: Whey
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Singleblind, randomized, crossover design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whey<br>Whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients). The intervention will be ingested 30 min. prior to an OGTT (3 hours). The intervention will also be ingested 30 min prior to breakfast in the women's own environment. | Dietary Supplement: Whey<br>* 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))<br>|
| Placebo Comparator: Placebo<br>The placebo will be ingested 30 min. prior to an OGTT (3 hours). The placebo will also be ingested 30 min prior to breakfast in the women's own environment. | Dietary Supplement: Placebo<br>* The placebo contains <1 kcal and 0 g protein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration differences in blood glucose following an OGTT |  | 3 hours following the OGTT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration differences in glucose independent peptide (GIP) |  | 3 hours following the OGTT | 
| 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 | 
| Gastric emptying rate (Concentration differences in blood paracetamol/acetaminophen) |  | 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 | A visual analogue scale ranging from not at all to extremely will be used to assess Hunger, Fullness, Satiety, Desire, Prospective consumption (Quantity). | 3 hours following the OGTT and 3 hours following breakfast | 
| Heart rate | A combined accelerometer and heart rate monitor will be used to measure heart rate (beats/minute) | 5 days | 
| Energy expenditure | A combined accelerometer and heart rate monitor will be used to estimate energy expenditure (kCal) | 5 days | 
| Activity | A combined accelerometer and heart rate monitor will be used to measure activity (counts/minute) | 5 days | 
| Continuous glucose measurements (CGM) | Time in range, concentration differences in interstitial fluid glucose 3 hours following breakfast, glycemic variability, mean glucose, daily maximum glucose, estimated HbA1c | 5 days |