Whey Protein Pre-load and Postprandial Glycemia in Pregnancy

NCT06170905 | Completed

• 1 other identifier: 78/23
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Postprandial Glycemia

Keywords

postprandial glucose excursions; glycemia; whey protein; protein pre-load; pregnancy; gestational diabetes mellitus; insulin secretion; incretins

Outcome Measures

Primary Outcomes (2)

• Glucose course

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

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

• Postprandial glucose excursion

  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.

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

Secondary Outcomes (8)

• Insulin course

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

• C-peptide course

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

• Insulin secretion

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

• Insulin sensitivity

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

• Glucagon course

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

Study Arms (2)

Oral glucose tolerance test with whey protein pre-load

EXPERIMENTAL

30 minutes prior to the 75 g OGTT, a whey protein solution is given.

Dietary Supplement: Whey protein-preload OGTT

Control oral glucose tolerance

NO INTERVENTION

75 g OGTT without whey protein pre-load.

Interventions

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

Oral glucose tolerance test with whey protein pre-load

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

Universityhospital Ulm

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Martin martin.heni@uniklinik-ulm.de, Prof.

  University Hospital Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Martin Heni

Model Details: Each participant will undergo two oral glucose tolerance tests (i) one with whey protein pre-load and (ii) one without, in a randomized order.

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 14, 2023
• Study Start: February 1, 2024
• Primary Completion: April 17, 2025
• Study Completion: October 22, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

DE (1)