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

Not Applicable

Completed

• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Whey

• Registration Number: NCT04767880
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-23
• Study Start: 2021-04-26
• Status Verified: 2022-05
• Primary Completion: 2023-09-29
• Study Completion: 2023-09-29
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Whey	Whey	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.

Primary Outcome Measures

Name	Time	Method
Concentration differences in blood glucose following an OGTT	3 hours following the OGTT

Secondary Outcome Measures

Name	Time	Method
Concentration differences in leptin	3 hours following the OGTT
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
Concentration differences in glucagon like peptide 1 (GLP-1)	3 hours following the OGTT
Concentration differences in ghrelin	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).
Concentration differences in glucose independent peptide (GIP)	3 hours following the OGTT
Concentration differences in glucagon	3 hours following the OGTT
Concentration differences in c-peptide	3 hours following the OGTT
Respiratory quotient (RQ)	3 hours following the OGTT
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)
Concentration differences in insulin	3 hours following the OGTT
Resting energy expenditure (REE) (Resting Metabolic Rate)	3 hours following the OGTT
Concentration differences in free fatty acids (FFA)	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
Heart rate	5 days	A combined accelerometer and heart rate monitor will be used to measure heart rate (beats/minute)

Trial Locations

Locations (1)

Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital; 🇩🇰 Aarhus, Denmark