Whey Protein Pre-load and Postprandial Glycemia in Pregnancy

NCT ID: NCT06170905

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-10-22

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 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.

Conditions

Pregnancy; Postprandial Glycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Oral glucose tolerance test with whey protein pre-load

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

Group Type: EXPERIMENTAL

Whey protein-preload OGTT

Intervention Type: 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

Control oral glucose tolerance

75 g OGTT without whey protein pre-load.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Whey protein-preload OGTT

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Martin Heni

Prof. Martin Heni

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ulm

Locations

Universityhospital Ulm

Ulm, , Germany

Countries

Germany

Other Identifiers

78/23

Identifier Type: -

Identifier Source: org_study_id