PregnancyProGsNCT06170905
Whey Protein Pre-load and Postprandial Glycemia in Pregnancy
A study testing Whey protein-preload OGTT in people with Pregnancy and Postprandial Glycemia, run by University of Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Postprandial Glycemia
- What is being tested?
- Whey protein-preload OGTT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2024to 22 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Whey Protein on Postprandial Glucose Excursions in Pregnant Women
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.
Read the 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
- Being tested
- Whey protein-preload OGTT
- Keywords
- postprandial glucose excursions, glycemia, whey protein, protein pre-load, pregnancy, gestational diabetes mellitus, insulin secretion, incretins
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein-preload OGTTDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Oral glucose tolerance test with whey protein pre-load | Experimental | 30 minutes prior to the 75 g OGTT, a whey protein solution is given. Receives: Dietary Supplement: Whey protein-preload OGTT |
| Control oral glucose tolerance | No intervention | 75 g OGTT without whey protein pre-load. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Timepoint 0-120 minutes during the oral glucose tolerance test.
Secondary outcomes (8)
Insulin course
Course of insulin assessed during the 75 g oral glucose tolerance test in pregnant women.
Measured: Timepoint 0-120 minutes during the oral glucose tolerance test.
C-peptide course
Course C-peptide assessed during the 75 g oral glucose tolerance test in pregnant women.
Measured: Timepoint 0-120 minutes during the oral glucose tolerance test.
Insulin secretion
Insulin secretion assessed during the 75 g oral glucose tolerance test in pregnant women.
Measured: Timepoint 0-120 minutes during the oral glucose tolerance test.
Insulin sensitivity
Insulin sensitivity assessed during the 75 g oral glucose tolerance test in pregnant women.
Measured: Timepoint 0-120 minutes during the oral glucose tolerance test.
Glucagon course
Course of glucagon and area under the glucagon curve assessed during the 75 g oral glucose tolerance test in pregnant women.
Measured: Timepoint 0-120 minutes during the oral glucose tolerance test.
GLP-1 course
Course of glucagon-like peptide 1 (GLP-1) and area under the GLP-1 curve assessed during the 75 g oral glucose tolerance test in pregnant women.
Measured: Timepoint 0-120 minutes during the oral glucose tolerance test.
GIP course
Course of glucose-dependent insulinotropic polypeptide (GIP) and area under the GIP curve assessed during the 75 g oral glucose tolerance test in pregnant women.
Measured: Timepoint 0-120 minutes during the oral glucose tolerance test.
Glicentin course
Course of glicentin and area under the glicentin curve assessed during the 75 g oral glucose tolerance test in pregnant women.
Measured: Timepoint 0-120 minutes during the oral glucose tolerance test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Feb 2024
- Primary completion17 Apr 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Heni, University of Ulm
- Investigators
- Martin martin.heni@uniklinik-ulm.de, Prof., Principal investigator, University Hospital Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170905
- Sponsor's protocol ID
- 78/23
- Acronym
- ProGs
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2023
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whey Protein on Postprandial Glucose Excursions in Pregnant Women
- ClinicalTrials.gov ID
- NCT06170905
- Acronym / sponsor ID
- ProGs / 78/23
- Conditions
- Pregnancy, Postprandial Glycemia
- Keywords
- postprandial glucose excursions, glycemia, whey protein, protein pre-load, pregnancy, gestational diabetes mellitus, insulin secretion, incretins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oral glucose tolerance test with whey protein pre-load | Experimental | Dietary Supplement: Whey protein-preload OGTT30 minutes prior to the 75 g OGTT, a whey protein solution is given. |
| Control oral glucose tolerance | No intervention | –75 g OGTT without whey protein pre-load. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey protein-preload OGTTIntake of 25 g whey protein diluted in water 30 minutes prior to the start of a regular 75 g oral glucose tolerance test | Dietary supplement | Oral glucose tolerance test with whey protein pre-load |
Primary outcome
Glucose course
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Course of plasma glucose assessed during a 75 g oral glucose tolerance test with vs without whey protein pre-load in pregnant women.
Postprandial glucose excursion
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
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.
8 secondary outcomes
Insulin course
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
C-peptide course
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Insulin secretion
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Insulin sensitivity
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Glucagon course
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
GLP-1 course
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
GIP course
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Glicentin course
Time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin martin.heni@uniklinik-ulm.de, Prof. principal investigator
University Hospital Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein-preload OGTT in people with Pregnancy and Postprandial Glycemia, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose course (time frame: Timepoint 0-120 minutes during the oral glucose tolerance test.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.