Status:

COMPLETED

Whey Protein Pre-load and Postprandial Glycemia in Pregnancy

Lead Sponsor:

University of Ulm

Conditions:

Pregnancy

Postprandial Glycemia

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

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.

Detailed Description

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 conc...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 22 2025

Estimated Enrollment :

21 Patients enrolled

Trial Details

Trial ID

NCT06170905

Start Date

February 1 2024

End Date

October 22 2025

Last Update

December 3 2025

Active Locations (1)

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1

Universityhospital Ulm

Ulm, Germany, 89081