Whey Protein Pre-load and Postprandial Glycemia in Pregnancy

Last updated: March 5, 2024
Sponsor: University of Ulm
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Treatment

Whey protein-preload OGTT

Clinical Study ID

NCT06170905
78/23
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 questionscientific success according to the physicians opinion.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Whey protein-preload OGTT
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
December 31, 2025

Study 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 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.

Connect with a study center

  • Universityhospital Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

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