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Completed

NCT Number: NCT06170905

Whey Protein Pre-load and Postprandial Glycemia in Pregnancy

This pilot study aims to investigate the intake of whey protein prior to carbohydrate intake as an approach to modulate postprandial glucose excursions during pregnancy.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universityhospital Ulm

Ulm, 89081, Germany

About this study

Gestational diabetes (GDM) has transgenerational health consequences and increases the risk of type 2 diabetes mellitus in both mother and child. However, there is a lack of practical nutritional concepts for the prevention and treatment of GDM. This randomized controlled pilot study investigates whether the intake of a protein drink before carbohydrate intake lowers postprandial blood glucose levels of pregnant women. Therefore, two 75g oral glucose tolerance tests are performed in 20 pregnant women in a cross-over design, whereby a whey protein solution is drunk 30 minutes before one of the oral glucose tolerance tests (OGTT). If a clinically relevant effect on blood glucose levels is identified, this project can clarify whether the reduction in postprandial glycemia was caused by changes in the secretion of insulin and incretins.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnant women between 24+0 and 27+6 (+/- 7 days) weeks of pregnancy after menstruation
  • BMI before pregnancy: 18 - 29.9 kg/m2
  • No known underlying diseases
  • Understanding and voluntary signing of a consent form before study-related examinations

Exclusion criteria

  • Age < 18 years
  • Diabetes mellitus type 1 or type 2
  • Drug therapy that raises or lowers blood sugar, e.g. steroids, antidiabetics, insulin.
  • Endocrine disorders (e.g. hyperthyroidism, polycystic ovary syndrome (PCOS), ...)
  • Current depression or other mental illnesses
  • Eating disorder
  • Regular intake of medication other than vitamins/trace elements during pregnancy
  • Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m²
  • C-reactive protein > 10 mg/l
  • Transaminase elevation of 2 times the upper norm
  • Pre-existing cardiac diseases
  • Drug and/or alcohol abuse
  • Hb < 12 g/dl
  • No consent to be informed about incidentally discovered pathological findings
  • Any other (clinical) condition that would endanger participants safety or question scientific success according to the physicians opinion.

Treatment and study plan

Whey protein-preload OGTT

Dietary Supplement

Intake of 25 g whey protein diluted in water 30 minutes prior to the start of a regular 75 g oral glucose tolerance test

Primary outcomes

  1. Glucose course

    Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.

    Course of plasma glucose assessed during a 75 g oral glucose tolerance test with vs without whey protein pre-load in pregnant women.

  2. Postprandial glucose excursion

    Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.

    Area under the glucose curve (AUC 0-30 Min. and AUC 0-120 Min.) and peak glucose assessed during a 75 g oral glucose tolerance test with vs without whey protein pre-load in pregnant women.

Secondary outcomes

  1. Insulin course

    Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.

    Course of insulin assessed during the 75 g oral glucose tolerance test in pregnant women.

  2. C-peptide course

    Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.

    Course C-peptide assessed during the 75 g oral glucose tolerance test in pregnant women.

  3. Insulin secretion

    Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.

    Insulin secretion assessed during the 75 g oral glucose tolerance test in pregnant women.

  4. Insulin sensitivity

    Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.

    Insulin sensitivity assessed during the 75 g oral glucose tolerance test in pregnant women.

  5. Glucagon course

    Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.

    Course of glucagon and area under the glucagon curve assessed during the 75 g oral glucose tolerance test in pregnant women.

  6. GLP-1 course

    Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.

    Course of glucagon-like peptide 1 (GLP-1) and area under the GLP-1 curve assessed during the 75 g oral glucose tolerance test in pregnant women.

  7. GIP course

    Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.

    Course of glucose-dependent insulinotropic polypeptide (GIP) and area under the GIP curve assessed during the 75 g oral glucose tolerance test in pregnant women.

  8. Glicentin course

    Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.

    Course of glicentin and area under the glicentin curve assessed during the 75 g oral glucose tolerance test in pregnant women.

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

Effect of Whey Protein on Postprandial Glucose Excursions in Pregnant Women

Acronym: ProGs

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 14, 2023
Registry last updated
Dec 3, 2025

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.

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