Clinical trial NCT06170905: Whey Protein Pre-load and Postprandial Glycemia in Pregnancy
Official title: Effect of Whey Protein on Postprandial Glucose Excursions in Pregnant Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy
Postprandial Glycemia
Keywords: postprandial glucose excursions
glycemia
whey protein
protein pre-load
pregnancy
gestational diabetes mellitus
insulin secretion
incretins
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will undergo two oral glucose tolerance tests (i) one with whey protein pre-load and (ii) one without, in a randomized order.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Glucose course
timeFrame: Timepoint 0-120 minutes during the oral glucose tolerance test.
measure: Postprandial glucose excursion
timeFrame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Secondary outcomes:
measure: Insulin course
timeFrame: Timepoint 0-120 minutes during the oral glucose tolerance test.
measure: C-peptide course
timeFrame: Timepoint 0-120 minutes during the oral glucose tolerance test.
measure: Insulin secretion
timeFrame: Timepoint 0-120 minutes during the oral glucose tolerance test.
measure: Insulin sensitivity
timeFrame: Timepoint 0-120 minutes during the oral glucose tolerance test.
measure: Glucagon course
timeFrame: Timepoint 0-120 minutes during the oral glucose tolerance test.
measure: GLP-1 course
timeFrame: Timepoint 0-120 minutes during the oral glucose tolerance test.
measure: GIP course
timeFrame: Timepoint 0-120 minutes during the oral glucose tolerance test.
measure: Glicentin course
timeFrame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Universityhospital Ulm
Study officials:
affiliation: University Hospital Ulm
name: Martin martin.heni@uniklinik-ulm.de, Prof.
role: PRINCIPAL_INVESTIGATOR
References: