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

NCT04767880 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-12-12

No results posted yet for this study

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

Interventions

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))

DIETARY_SUPPLEMENT

Placebo

The placebo contains \<1 kcal and 0 g protein

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2023-09-29
Completion
2023-09-29

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04767880 on ClinicalTrials.gov