Gestational DiabetesNCT04856800
Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery
A study testing Whey in people with Gestational Diabetes, run by University of Aarhus at 1 site in Denmark.
Trial summary
The main objective of the study is to investigate the metabolic effects of whey protein (whey protein isolate, WPI, (Lacprodan® ISO.Water. from Arla Foods Ingredients) compared with placebo when consumed by women with gestational diabetes mellitus (GDM) from diagnosis (around gestational week 28) to delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Whey
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2021to 31 Oct 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GDM (OGTT level of blood glucose ≥ 9 mmol/L)
- 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
- Medication with effect on glucose metabolism e.g. steroids
- Do not speak or understand Danish
- Twin pregnancy
Show all 13Show fewer
- PCOS
- PI finds the patient unfit (like mental illness, too nervous or other)
- Severe chronic illness
- Severe nausea/vomiting
- Non-breakfast eaters
- Celiac disease
- The initiation of insulin treatment during the trial will not lead to exclusion from the trial.
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 the study is to investigate the metabolic effects of whey protein (whey protein isolate, WPI, (Lacprodan® ISO.Water. from Arla Foods Ingredients) compared with placebo when consumed by women with gestational diabetes mellitus (GDM) from diagnosis (around gestational week 28) to delivery. Any changes in substrate metabolism and energy expenditure using indirect calorimetry will also be investigated. Differences in hunger and satiety parameters as well as blood pressure and gestational weight gain will also be assessed. Furthermore, analysis on the glucose response when the women consume the intervention (whey or placebo) at home in their own environment 30 minutes before breakfast at time of diagnosis (earliest week 28) and week 36 (four days following each time point) will be made. The women will be monitored with continuous glucose monitors, activity monitors and all meals will be provided for two days following the study days in the laboratory. At delivery cord blood will be sampled for analysis on metabolic parameters and investigations on epigenetics/DNA methylations. Complications to the delivery, neonatal outcomes, anthropometrics of the child will also be assessed. Breast milk composition will also be analyzed.
- Conditions
- Gestational Diabetes
- Being tested
- Whey, Placebo
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WheyDietary supplement
20 g protein of 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). 20 g of whey protein will be ingested 30 min. prior to breakfast from diagnosis of GDM (around week 28) and until delivery. Receives: Dietary Supplement: Whey |
| Placebo | Placebo comparator | The placebo will be ingested 30 min. prior to breakfast from diagnosis of GDM (around week 28) and until delivery. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal glycemic variability (GV)
The Coefficient of Variation, power: n = 50
Measured: 24 hours
Maternal glycemic variability (GV)
Interquartile range (IQR), power n = 40
Measured: 24 hours
Maternal glycemic variability (GV)
Standard deviation (SD), power n = 18
Measured: 24 hours
Secondary outcomes (69)
24 hours interstitial fluid glucose measures
Continuous glucose monitoring
Measured: 24 hours
mean glucose
Continuous glucose monitoring
Measured: 24 hours
maximum glucose
Continuous glucose monitoring
Measured: 24 hours
Interstitial fluid glucose concentrations
Continuous glucose monitoring
Measured: 3 hours following breakfast
Total energy expenditure
Measured with a combined accelerometer and heart rate monitor, reported in kcal
Measured: 24 hours
Activity energy expenditure
Measured with a combined accelerometer and heart rate monitor, reported in kcal
Measured: 24 hours
Activity count
Measured with a combined accelerometer and heart rate monitor, reported in counts
Measured: 24 hours
Heart rate
Measured with a combined accelerometer and heart rate monitor, reported in beats per minute
Measured: 24 hours
Resting energy expenditure (REE) (Resting Metabolic Rate)
Indirect calorimetry
Measured: Performed for 20 minutes
Respiratory quotient (RQ)
Indirect calorimetry
Measured: Performed for 20 minutes
Oxidation rates of lipid, carbohydrate and protein
Indirect calorimetry
Measured: Performed for 20 minutes
Diet diary
Total energy intake, composition of macronutrients
Measured: 24 hours
Self-reported appetite
Questionnaire: A numerical rating scale ranging from "not at all = 0" to "extremely = 10" will be used to assess Hunger, Fullness, Satiety, Desire, Prospective consumption (Quantity).
Measured: 3,5 hours following intake of whey/placebo at diagnosis, week 32 and week 36
Body Mass Index
weight and height will be combined to report BMI in kg/m^2
Measured: at diagnosis, week 32 and week 36
Gestational weight change
Measured: at diagnosis, week 32 and week 36
Medications
number of participants prescribed insulin, dose of insulin, time to insulin. Methyldopa, nifidipin or labetalol (medication to lower blood pressure)
Measured: from diagnosis to delivery
Pregnancy data
Number of participants with hypertension, preeclampsia, maternal weight gain
Measured: from diagnosis to delivery
Delivery data
Number of patients with cesarean section, shoulder dystocia, induction of labour
Measured: at delivery
Non-targeted metabolomics will be performed on a sample of breast milk using Nuclear Magnetic Resonance
Analysis generating metabolites from pathways on amino acids, peptides, carbohydrates and lipids measured in folds increase/decrease when comparing placebo with whey
Measured: Day 1 postpartum
Blood pressure
Systolic and diastolic blood pressure
Measured: at diagnosis, week 32 and week 36
Concentration differences in Insulin like growth factor I (IGF-1) (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in IGF-binding protein 3 (IGFBP-3) (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in IGF-binding protein 1 (IGFBP-1) (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in FGF-21 (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in Leptin (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in Adiponectin (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in CRP (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in Prolactin (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in Cortisol (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in Insulin (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in Free Fatty Acids (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in lactate (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in grehlin (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in inflammatory markers (IL-6, IL-10, IL-1α, IFN-γ, TNF-α)(mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in glucose independent peptide (GIP) (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in glucagon like peptide 1 (GLP-1) (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in glucagon (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in c-peptide (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in amino acids (AA) (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in progesterone (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in steroid hormone binding protein (SHBP) (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in carboxy-terminal collagen crosslinks (CTx) (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in osteocalcin (OCN) (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in Pro-collagen I, N-term. pro-peptide (PINP) (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in Human chorionic gonadotropin (HCG) (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in CD163 (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in estradiol (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in hb1ac (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in lipids (cholesterol, triglyceride) (mother)
Measured: at diagnosis, week 32 and week 36
Concentration differences in Insulin (cord blood, offspring)
Measured: at delivery
Concentration differences in c-peptide (cord blood, offspring)
Measured: at delivery
Concentration differences in glucagon (cord blood, offspring)
Measured: at delivery
Concentration differences in glucose (cord blood, offspring)
Measured: at delivery
Concentration differences in lactate (cord blood, offspring)
Measured: at delivery
Differences in pH (cord blood, offspring)
Measurement of acidity of the blood. Standard measurement performed on a sample of cord blood when a baby is delivered to evaluate possible oxygen deficiency during delivery.
Measured: at delivery
non-targeted metabolomics analysis (cord blood, offspring)
Analysis generating metabolites from pathways on amino acids, peptides, carbohydrates, lipids and energy measured in folds rise/fall in when comparing placebo with whey
Measured: at delivery
DNA methylations measured with 850K-Illumina Infinium assay.
Differentially methylated sites or regions associated with the intervention will be assessed.
Measured: at delivery
RNA-Seq transcriptome profiling
Up and down-regulated genes associated with the intervention will be assessed
Measured: at delivery
Body fat (offspring)
Sum of skinfolds measured with a caliper
Measured: at delivery
Birth weight (offspring)
Measured: at delivery
Head circumference (offspring)
Measured: at delivery
abdominal circumference (offspring)
Measured: at delivery
Length (offspring)
Measured: at delivery
Number of infants with icterus
Measured: through hospital admission immediately after delivery
Apgar-score
Apgar score, range from 0-10, with the higher score the better outcome.
Measured: at delivery
number of patients needing early feeding
Measured: through hospital admission immediately after delivery
Number of days admitted immediately after delivery
Measured: through hospital admission immediately after delivery
Number of infants with hypoglycemia
Measured: at delivery
Weight of placenta
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Dec 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856800
- Sponsor's protocol ID
- 1-10-72-326-20
- Status last verified
- May 2022
- First submitted
- 23 Mar 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery
- ClinicalTrials.gov ID
- NCT04856800
- Acronym / sponsor ID
- 1-10-72-326-20
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 23 Apr 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 the study is to investigate the metabolic effects of whey protein (whey protein isolate, WPI, (Lacprodan® ISO.Water. from Arla Foods Ingredients) compared with placebo when consumed by women with gestational diabetes mellitus (GDM) from diagnosis (around gestational week 28) to delivery. Any changes in substrate metabolism and energy expenditure using indirect calorimetry will also be investigated. Differences in hunger and satiety parameters as well as blood pressure and gestational weight gain will also be assessed. Furthermore, analysis on the glucose response when the women consume the intervention (whey or placebo) at home in their own environment 30 minutes before breakfast at time of diagnosis (earliest week 28) and week 36 (four days following each time point) will be made. The women will be monitored with continuous glucose monitors, activity monitors and all meals will be provided for two days following the study days in the laboratory. At delivery cord blood will be sampled for analysis on metabolic parameters and investigations on epigenetics/DNA methylations. Complications to the delivery, neonatal outcomes, anthropometrics of the child will also be assessed. Breast milk composition will also be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey | Experimental | Dietary Supplement: WheyWhey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients). 20 g of whey protein will be ingested 30 min. prior to breakfast from diagnosis of GDM (around week 28) and until delivery. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo will be ingested 30 min. prior to breakfast from diagnosis of GDM (around week 28) and until delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- GDM (OGTT level of blood glucose ≥ 9 mmol/L)
- Normal blood pressure
- Age > 18 years
Key exclusion criteria (13 listed)
- Special dietary regimes > 1 month at time of inclusion e.g. ketogenic diet
- Daily intake of protein supplements
- Milk allergy or phenylketonuria
- Medication with effect on glucose metabolism e.g. steroids
- Do not speak or understand Danish
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 |
|---|---|---|
| Whey20 g protein of 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
Maternal glycemic variability (GV)
Time frame: 24 hours
The Coefficient of Variation, power: n = 50
Maternal glycemic variability (GV)
Time frame: 24 hours
Interquartile range (IQR), power n = 40
Maternal glycemic variability (GV)
Time frame: 24 hours
Standard deviation (SD), power n = 18
69 secondary outcomes
24 hours interstitial fluid glucose measures
Time frame: 24 hours
mean glucose
Time frame: 24 hours
maximum glucose
Time frame: 24 hours
Interstitial fluid glucose concentrations
Time frame: 3 hours following breakfast
Total energy expenditure
Time frame: 24 hours
Activity energy expenditure
Time frame: 24 hours
Activity count
Time frame: 24 hours
Heart rate
Time frame: 24 hours
Resting energy expenditure (REE) (Resting Metabolic Rate)
Time frame: Performed for 20 minutes
Respiratory quotient (RQ)
Time frame: Performed for 20 minutes
Oxidation rates of lipid, carbohydrate and protein
Time frame: Performed for 20 minutes
Diet diary
Time frame: 24 hours
Self-reported appetite
Time frame: 3,5 hours following intake of whey/placebo at diagnosis, week 32 and week 36
Body Mass Index
Time frame: at diagnosis, week 32 and week 36
Gestational weight change
Time frame: at diagnosis, week 32 and week 36
Medications
Time frame: from diagnosis to delivery
Pregnancy data
Time frame: from diagnosis to delivery
Delivery data
Time frame: at delivery
Non-targeted metabolomics will be performed on a sample of breast milk using Nuclear Magnetic Resonance
Time frame: Day 1 postpartum
Blood pressure
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Insulin like growth factor I (IGF-1) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in IGF-binding protein 3 (IGFBP-3) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in IGF-binding protein 1 (IGFBP-1) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in FGF-21 (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Leptin (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Adiponectin (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in CRP (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Prolactin (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Cortisol (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Insulin (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in Free Fatty Acids (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in lactate (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in grehlin (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in inflammatory markers (IL-6, IL-10, IL-1α, IFN-γ, TNF-α)(mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in glucose independent peptide (GIP) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in glucagon like peptide 1 (GLP-1) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in glucagon (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in c-peptide (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in amino acids (AA) (mother)
Time frame: at diagnosis, week 32 and week 36
Concentration differences in progesterone (mother)
Time frame: at diagnosis, week 32 and week 36
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 3 inclusion and 13 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?
Maternal glycemic variability (GV) (time frame: 24 hours). The study lists 3 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 12 Dec 2023.