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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Dietary supplement: Whey; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 Comparator: 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.	Dietary supplement: Placebo; The placebo contains <1 kcal and 0 g protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Director: Per G Ovesen, Professor, Institute of Clinical Medicine, Aarhus University and Department of Gynecology and Obstetrics and Steno Diabetes Center Aarhus, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: 1-10-72-305-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No