Clinical trial NCT04767880: Acute Metabolic Effects of Pre-meal Consumption of Whey in Women at Risk of Gestational Diabetes Mellitus
Official title: Acute Metabolic Effects of Pre-meal Consumption of Whey in Women at Risk of Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Singleblind, randomized, crossover design
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Concentration differences in blood glucose following an OGTT
timeFrame: 3 hours following the OGTT
Secondary outcomes:
measure: Concentration differences in glucose independent peptide (GIP)
timeFrame: 3 hours following the OGTT
measure: Concentration differences in glucagon like peptide 1 (GLP-1)
timeFrame: 3 hours following the OGTT
measure: Concentration differences in glucagon
timeFrame: 3 hours following the OGTT
measure: Concentration differences in insulin
timeFrame: 3 hours following the OGTT
measure: Concentration differences in c-peptide
timeFrame: 3 hours following the OGTT
measure: Concentration differences in free fatty acids (FFA)
timeFrame: 3 hours following the OGTT
measure: Concentration differences in ghrelin
timeFrame: 3 hours following the OGTT
measure: Concentration differences in leptin
timeFrame: 3 hours following the OGTT
measure: Concentration differences in amino acids (AA)
timeFrame: 3 hours following the OGTT
measure: Gastric emptying rate (Concentration differences in blood paracetamol/acetaminophen)
timeFrame: 3 hours following the OGTT
measure: Resting energy expenditure (REE) (Resting Metabolic Rate)
timeFrame: 3 hours following the OGTT
measure: Respiratory quotient (RQ)
timeFrame: 3 hours following the OGTT
measure: Self-reported appetite
timeFrame: 3 hours following the OGTT and 3 hours following breakfast
measure: Heart rate
timeFrame: 5 days
measure: Energy expenditure
timeFrame: 5 days
measure: Activity
timeFrame: 5 days
measure: Continuous glucose measurements (CGM)
timeFrame: 5 days
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital
Study officials:
affiliation: Institute of Clinical Medicine, Aarhus University and Department of Gynecology and Obstetrics and Steno Diabetes Center Aarhus, Aarhus University Hospital
name: Per G Ovesen, Professor
role: STUDY_DIRECTOR
References: