Gestational Diabetes Mellitus in PregnancyNCT04767880
Acute Metabolic Effects of Pre-meal Consumption of Whey in Women at Risk of Gestational Diabetes Mellitus
A study testing Whey in people with Gestational Diabetes Mellitus in Pregnancy, run by University of Aarhus at 1 site in Denmark.
Trial summary
The main objective of our study is to investigate the metabolic effects of whey protein (whey protein isolate, WPI, (Lacprodan® ISO.Water. from Arla Foods Ingredients) compared to placebo when consumed by women in risk of gestational diabetes mellitus (GMD) 30 minutes prior to an oral glucose tolerance test (OGTT). 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
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Whey
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Apr 2021to 29 Sep 2023
- 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
- Referred to screening for Gestational Diabetes Mellitus by week 24-30 or GDM
- BMI 20-35
- Normal blood pressure
- Age > 18 years
Who cannot join
- Special dietary regimes > 1 month at time of inclusion e.g. ketogenic diet
- Daily intake of protein supplements
- Milk allergy or phenylketonuria
- Celiac disease
- Medication with effect on glucose metabolism e.g. steroid
- Do not speak or understand Danish
Show all 14Show fewer
- Gemelli
- Polycystic Ovarian Syndrome
- PI finds the patient unfit (like mental illness, too nervous or other)
- Anemia (hemoglobin <6 mmol/l)
- Severe chronic illness
- Depression
- Severe nausea/vomiting
- Non-breakfast eaters
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital
Aarhus
About this study
The main objective of our study is to investigate the metabolic effects of whey protein (whey protein isolate, WPI, (Lacprodan® ISO.Water. from Arla Foods Ingredients) compared to placebo when consumed by women in risk of gestational diabetes mellitus (GMD) 30 minutes prior to an oral glucose tolerance test (OGTT). We will also investigate any changes in substrate metabolism and energy expenditure using indirect calorimetry. Differences in hunger and satiety parameters as well as rate of gastric emptying will also be assessed. Furthermore, we will investigate the glucose response when the women consume the intervention at home in their own environment 30 minutes before breakfast in various doses (placebo, 10, 15, 20, 30 g whey). The women will be monitored with continuous glucose monitors, activity monitors and all meals will be provided.
The two study days in the laboratory will be repeated 3-9 months after pregnancy. The purpose of this is to be able to compare the metabolic response of pre-meal whey during pregnancy with the response in a not-pregnant state. The study days at home will not be repeated after pregnancy.
- Being tested
- Whey, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WheyDietary supplement
Doses of 10, 15, 20 and 30 gram protein of a regular whey protein compound (whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients))
PlaceboDietary supplement
The placebo contains <1 kcal and 0 g protein
| Study group | Role | What they receive |
|---|---|---|
| Whey | Experimental | Whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients). The intervention will be ingested 30 min. prior to an OGTT (3 hours). The intervention will also be ingested 30 min prior to breakfast in the women's own environment. Receives: Dietary Supplement: Whey |
| Placebo | Placebo comparator | The placebo will be ingested 30 min. prior to an OGTT (3 hours). The placebo will also be ingested 30 min prior to breakfast in the women's own environment. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration differences in blood glucose following an OGTT
Measured: 3 hours following the OGTT
Secondary outcomes (17)
Concentration differences in glucose independent peptide (GIP)
Measured: 3 hours following the OGTT
Concentration differences in glucagon like peptide 1 (GLP-1)
Measured: 3 hours following the OGTT
Concentration differences in glucagon
Measured: 3 hours following the OGTT
Concentration differences in insulin
Measured: 3 hours following the OGTT
Concentration differences in c-peptide
Measured: 3 hours following the OGTT
Concentration differences in free fatty acids (FFA)
Measured: 3 hours following the OGTT
Concentration differences in ghrelin
Measured: 3 hours following the OGTT
Concentration differences in leptin
Measured: 3 hours following the OGTT
Concentration differences in amino acids (AA)
Measured: 3 hours following the OGTT
Gastric emptying rate (Concentration differences in blood paracetamol/acetaminophen)
Measured: 3 hours following the OGTT
Resting energy expenditure (REE) (Resting Metabolic Rate)
Measured: 3 hours following the OGTT
Respiratory quotient (RQ)
Measured: 3 hours following the OGTT
Self-reported appetite
A visual analogue scale ranging from "not at all" to "extremely" will be used to assess Hunger, Fullness, Satiety, Desire, Prospective consumption (Quantity).
Measured: 3 hours following the OGTT and 3 hours following breakfast
Heart rate
A combined accelerometer and heart rate monitor will be used to measure heart rate (beats/minute)
Measured: 5 days
Energy expenditure
A combined accelerometer and heart rate monitor will be used to estimate energy expenditure (kCal)
Measured: 5 days
Activity
A combined accelerometer and heart rate monitor will be used to measure activity (counts/minute)
Measured: 5 days
Continuous glucose measurements (CGM)
Time in range, concentration differences in interstitial fluid glucose 3 hours following breakfast, glycemic variability, mean glucose, daily maximum glucose, estimated HbA1c
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start26 Apr 2021
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Singleblind, randomized, crossover design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per G Ovesen, Professor, Study director, Institute of Clinical Medicine, Aarhus University and Department of Gynecology and Obstetrics and Steno Diabetes Center Aarhus, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767880
- Sponsor's protocol ID
- 1-10-72-305-20
- Status last verified
- May 2022
- First submitted
- 12 Feb 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smedegaard S, Rittig N, Ovesen PG, Suder LB, Knudsen JH, Brunsgaard LH, Kampmann U. Once-daily supplementation with pre-meal whey protein lowers breakfast postprandial glucose levels in women with GDM throughout the third trimester: a randomised, controlled, clinical trial. Diabetologia. 2026 Feb;69(2):350-363. doi: 10.1007/s00125-025-06587-0. Epub 2025 Nov 7.
PubMed 41203981
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Metabolic Effects of Pre-meal Consumption of Whey in Women at Risk of Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04767880
- Acronym / sponsor ID
- 1-10-72-305-20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 23 Feb 2021 (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.
The main objective of our study is to investigate the metabolic effects of whey protein (whey protein isolate, WPI, (Lacprodan® ISO.Water. from Arla Foods Ingredients) compared to placebo when consumed by women in risk of gestational diabetes mellitus (GMD) 30 minutes prior to an oral glucose tolerance test (OGTT). We will also investigate any changes in substrate metabolism and energy expenditure using indirect calorimetry. Differences in hunger and satiety parameters as well as rate of gastric emptying will also be assessed. Furthermore, we will investigate the glucose response when the women consume the intervention at home in their own environment 30 minutes before breakfast in various doses (placebo, 10, 15, 20, 30 g whey). The women will be monitored with continuous glucose monitors, activity monitors and all meals will be provided.
The two study days in the laboratory will be repeated 3-9 months after pregnancy. The purpose of this is to be able to compare the metabolic response of pre-meal whey during pregnancy with the response in a not-pregnant state. The study days at home will not be repeated after pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Singleblind, randomized, crossover design
| Arm | Type | Receives |
|---|---|---|
| Whey | Experimental | Dietary Supplement: WheyWhey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients). The intervention will be ingested 30 min. prior to an OGTT (3 hours). The intervention will also be ingested 30 min prior to breakfast in the women's own environment. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo will be ingested 30 min. prior to an OGTT (3 hours). The placebo will also be ingested 30 min prior to breakfast in the women's own environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Referred to screening for Gestational Diabetes Mellitus by week 24-30 or GDM
- BMI 20-35
- Normal blood pressure
- Age > 18 years
Key exclusion criteria (14 listed)
- Special dietary regimes > 1 month at time of inclusion e.g. ketogenic diet
- Daily intake of protein supplements
- Milk allergy or phenylketonuria
- Celiac disease
- Medication with effect on glucose metabolism e.g. steroid
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 |
|---|---|---|
| WheyDoses of 10, 15, 20 and 30 gram protein of a regular whey protein compound (whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients)) | Dietary supplement | Whey |
| PlaceboThe placebo contains <1 kcal and 0 g protein | Dietary supplement | Placebo |
Primary outcome
Concentration differences in blood glucose following an OGTT
Time frame: 3 hours following the OGTT
17 secondary outcomes
Concentration differences in glucose independent peptide (GIP)
Time frame: 3 hours following the OGTT
Concentration differences in glucagon like peptide 1 (GLP-1)
Time frame: 3 hours following the OGTT
Concentration differences in glucagon
Time frame: 3 hours following the OGTT
Concentration differences in insulin
Time frame: 3 hours following the OGTT
Concentration differences in c-peptide
Time frame: 3 hours following the OGTT
Concentration differences in free fatty acids (FFA)
Time frame: 3 hours following the OGTT
Concentration differences in ghrelin
Time frame: 3 hours following the OGTT
Concentration differences in leptin
Time frame: 3 hours following the OGTT
Concentration differences in amino acids (AA)
Time frame: 3 hours following the OGTT
Gastric emptying rate (Concentration differences in blood paracetamol/acetaminophen)
Time frame: 3 hours following the OGTT
Resting energy expenditure (REE) (Resting Metabolic Rate)
Time frame: 3 hours following the OGTT
Respiratory quotient (RQ)
Time frame: 3 hours following the OGTT
Self-reported appetite
Time frame: 3 hours following the OGTT and 3 hours following breakfast
Heart rate
Time frame: 5 days
Energy expenditure
Time frame: 5 days
Activity
Time frame: 5 days
Continuous glucose measurements (CGM)
Time frame: 5 days
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 12 Dec 2023.
- Derived from this study: PubMed 41203981Smedegaard S, Rittig N, Ovesen PG, Suder LB, Knudsen JH, Brunsgaard LH, Kampmann U. Once-daily supplementation with pre-meal whey protein lowers breakfast postprandial glucose levels in women with GDM throughout the third trimester: a randomised, controlled, clinical trial. Diabetologia. 2026 Feb;69(2):350-363. doi: 10.1007/s00125-025-06587-0. Epub 2025 Nov 7.
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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.
Per G Ovesen, Professor study director
Institute of Clinical Medicine, Aarhus University and Department of Gynecology and Obstetrics and Steno Diabetes Center Aarhus, Aarhus University Hospital
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 in people with Gestational Diabetes Mellitus in Pregnancy, run by University of Aarhus at 1 site in Denmark.
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 14 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 12 Dec 2023. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Concentration differences in blood glucose following an OGTT (time frame: 3 hours following the OGTT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04767880, which also lists 1 linked publication.
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 12 Dec 2023.