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

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04767880
• Other study ID #: 1-10-72-305-20
• Status: Completed
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: September 29, 2023

Study information

• Verified date: May 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 29, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Dietary Supplement:
• Whey
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))
• Placebo
The placebo contains <1 kcal and 0 g protein

Locations

Country	Name	City	State
Denmark	Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration differences in blood glucose following an OGTT		3 hours following the OGTT
Secondary	Concentration differences in glucose independent peptide (GIP)		3 hours following the OGTT
Secondary	Concentration differences in glucagon like peptide 1 (GLP-1)		3 hours following the OGTT
Secondary	Concentration differences in glucagon		3 hours following the OGTT
Secondary	Concentration differences in insulin		3 hours following the OGTT
Secondary	Concentration differences in c-peptide		3 hours following the OGTT
Secondary	Concentration differences in free fatty acids (FFA)		3 hours following the OGTT
Secondary	Concentration differences in ghrelin		3 hours following the OGTT
Secondary	Concentration differences in leptin		3 hours following the OGTT
Secondary	Concentration differences in amino acids (AA)		3 hours following the OGTT
Secondary	Gastric emptying rate (Concentration differences in blood paracetamol/acetaminophen)		3 hours following the OGTT
Secondary	Resting energy expenditure (REE) (Resting Metabolic Rate)		3 hours following the OGTT
Secondary	Respiratory quotient (RQ)		3 hours following the OGTT
Secondary	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
Secondary	Heart rate	A combined accelerometer and heart rate monitor will be used to measure heart rate (beats/minute)	5 days
Secondary	Energy expenditure	A combined accelerometer and heart rate monitor will be used to estimate energy expenditure (kCal)	5 days
Secondary	Activity	A combined accelerometer and heart rate monitor will be used to measure activity (counts/minute)	5 days
Secondary	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