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

NCT04767880 | Completed

• 1 other identifier: 1-10-72-305-20
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Concentration differences in blood glucose following an OGTT

  3 hours following the OGTT

Secondary Outcomes (17)

• 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

Study Arms (2)

Whey

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Whey DIETARY_SUPPLEMENT

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))

Whey

Placebo DIETARY_SUPPLEMENT

The placebo contains \<1 kcal and 0 g protein

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred to screening for Gestational Diabetes Mellitus by week 24-30 or GDM
• BMI 20-35
• Normal blood pressure
• Age \> 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

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

Aarhus, Denmark

Location

Related Publications (1)

• Smedegaard S, Rittig N, Ovesen PG, Suder LB, Knudsen JH, Brunsgaard LH, Kampmann U. Once-daily supplementation with pre-meal whey protein lowers breakfast postprandial glucose levels in women with GDM throughout the third trimester: a randomised, controlled, clinical trial. Diabetologia. 2026 Feb;69(2):350-363. doi: 10.1007/s00125-025-06587-0. Epub 2025 Nov 7.

  PMID: 41203981 DERIVED

MeSH Terms

Interventions

Whey

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the intervention and placebo in the laboratory setting. Quadruple (Participants, care providers, investigators and outcome assessors) Participants, care providers, investigators and outcome assessors will be blinded to the placebo and varying doses of whey in the home setting.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Singleblind, randomized, crossover design

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 23, 2021
• Study Start: April 26, 2021
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: December 12, 2023

Record last verified: 2022-05

Locations

DK (1)