Skip to main content
OpenTrials
Completed

NCT Number: NCT04767880

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Aarhus, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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))

Placebo

Dietary Supplement

The placebo contains <1 kcal and 0 g protein

Primary outcomes

  1. Concentration differences in blood glucose following an OGTT

    Time frame: 3 hours following the OGTT

Secondary outcomes

  1. Concentration differences in glucose independent peptide (GIP)

    Time frame: 3 hours following the OGTT

  2. Concentration differences in glucagon like peptide 1 (GLP-1)

    Time frame: 3 hours following the OGTT

  3. Concentration differences in glucagon

    Time frame: 3 hours following the OGTT

  4. Concentration differences in insulin

    Time frame: 3 hours following the OGTT

  5. Concentration differences in c-peptide

    Time frame: 3 hours following the OGTT

  6. Concentration differences in free fatty acids (FFA)

    Time frame: 3 hours following the OGTT

  7. Concentration differences in ghrelin

    Time frame: 3 hours following the OGTT

  8. Concentration differences in leptin

    Time frame: 3 hours following the OGTT

  9. Concentration differences in amino acids (AA)

    Time frame: 3 hours following the OGTT

  10. Gastric emptying rate (Concentration differences in blood paracetamol/acetaminophen)

    Time frame: 3 hours following the OGTT

  11. Resting energy expenditure (REE) (Resting Metabolic Rate)

    Time frame: 3 hours following the OGTT

  12. Respiratory quotient (RQ)

    Time frame: 3 hours following the OGTT

  13. Self-reported appetite

    Time frame: 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).

  14. Heart rate

    Time frame: 5 days

    A combined accelerometer and heart rate monitor will be used to measure heart rate (beats/minute)

  15. Energy expenditure

    Time frame: 5 days

    A combined accelerometer and heart rate monitor will be used to estimate energy expenditure (kCal)

  16. Activity

    Time frame: 5 days

    A combined accelerometer and heart rate monitor will be used to measure activity (counts/minute)

  17. Continuous glucose measurements (CGM)

    Time frame: 5 days

    Time in range, concentration differences in interstitial fluid glucose 3 hours following breakfast, glycemic variability, mean glucose, daily maximum glucose, estimated HbA1c

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2021
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.