Whey Protein Pre-load and Postprandial Glycemia in Pregnancy (NCT06170905) | Clinical Trial Compass
CompletedNot Applicable
Whey Protein Pre-load and Postprandial Glycemia in Pregnancy
Germany21 participantsStarted 2024-02-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Glucose course
Timeframe: Timepoint 0-120 minutes during the oral glucose tolerance test.
2
Postprandial glucose excursion
Timeframe: Timepoint 0-120 minutes during the oral glucose tolerance test.