Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery
- Conditions
- Gestational Diabetes
- Interventions
- Dietary Supplement: WheyDietary Supplement: Placebo
- Registration Number
- NCT04856800
- Lead Sponsor
- University of Aarhus
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 48
- GDM (OGTT level of blood glucose ≥ 9 mmol/L)
- Normal blood pressure
- Age > 18 years
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Whey Whey 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. Placebo Placebo The placebo will be ingested 30 min. prior to breakfast from diagnosis of GDM (around week 28) and until delivery.
- Primary Outcome Measures
Name Time Method Maternal glycemic variability (GV) 24 hours Standard deviation (SD), power n = 18
- Secondary Outcome Measures
Name Time Method Concentration differences in lactate (mother) at diagnosis, week 32 and week 36 Concentration differences in grehlin (mother) at diagnosis, week 32 and week 36 Concentration differences in Insulin like growth factor I (IGF-1) (mother) at diagnosis, week 32 and week 36 Birth weight (offspring) at delivery 24 hours interstitial fluid glucose measures 24 hours Continuous glucose monitoring
mean glucose 24 hours Continuous glucose monitoring
maximum glucose 24 hours Continuous glucose monitoring
Oxidation rates of lipid, carbohydrate and protein Performed for 20 minutes Indirect calorimetry
Concentration differences in CD163 (mother) at diagnosis, week 32 and week 36 Concentration differences in lipids (cholesterol, triglyceride) (mother) at diagnosis, week 32 and week 36 RNA-Seq transcriptome profiling at delivery Up and down-regulated genes associated with the intervention will be assessed
Concentration differences in Insulin (cord blood, offspring) at delivery non-targeted metabolomics analysis (cord blood, offspring) at delivery Analysis generating metabolites from pathways on amino acids, peptides, carbohydrates, lipids and energy measured in folds rise/fall in when comparing placebo with whey
Concentration differences in estradiol (mother) at diagnosis, week 32 and week 36 Concentration differences in hb1ac (mother) at diagnosis, week 32 and week 36 Concentration differences in c-peptide (cord blood, offspring) at delivery Concentration differences in glucagon (cord blood, offspring) at delivery DNA methylations measured with 850K-Illumina Infinium assay. at delivery Differentially methylated sites or regions associated with the intervention will be assessed.
Interstitial fluid glucose concentrations 3 hours following breakfast Continuous glucose monitoring
Differences in pH (cord blood, offspring) at delivery 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.
Body fat (offspring) at delivery Sum of skinfolds measured with a caliper
Heart rate 24 hours Measured with a combined accelerometer and heart rate monitor, reported in beats per minute
Gestational weight change at diagnosis, week 32 and week 36 Medications from diagnosis to delivery number of participants prescribed insulin, dose of insulin, time to insulin. Methyldopa, nifidipin or labetalol (medication to lower blood pressure)
Concentration differences in Leptin (mother) at diagnosis, week 32 and week 36 Concentration differences in Adiponectin (mother) at diagnosis, week 32 and week 36 Self-reported appetite 3,5 hours following intake of whey/placebo at diagnosis, week 32 and week 36 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).
Concentration differences in FGF-21 (mother) at diagnosis, week 32 and week 36 Concentration differences in Prolactin (mother) at diagnosis, week 32 and week 36 Concentration differences in Cortisol (mother) at diagnosis, week 32 and week 36 Concentration differences in Free Fatty Acids (mother) at diagnosis, week 32 and week 36 Total energy expenditure 24 hours Measured with a combined accelerometer and heart rate monitor, reported in kcal
Activity energy expenditure 24 hours Measured with a combined accelerometer and heart rate monitor, reported in kcal
Activity count 24 hours Measured with a combined accelerometer and heart rate monitor, reported in counts
Respiratory quotient (RQ) Performed for 20 minutes Indirect calorimetry
Diet diary 24 hours Total energy intake, composition of macronutrients
Pregnancy data from diagnosis to delivery Number of participants with hypertension, preeclampsia, maternal weight gain
Delivery data at delivery Number of patients with cesarean section, shoulder dystocia, induction of labour
Non-targeted metabolomics will be performed on a sample of breast milk using Nuclear Magnetic Resonance Day 1 postpartum Analysis generating metabolites from pathways on amino acids, peptides, carbohydrates and lipids measured in folds increase/decrease when comparing placebo with whey
abdominal circumference (offspring) at delivery Number of infants with icterus through hospital admission immediately after delivery Concentration differences in IGF-binding protein 1 (IGFBP-1) (mother) at diagnosis, week 32 and week 36 Apgar-score at delivery Apgar score, range from 0-10, with the higher score the better outcome.
Concentration differences in Insulin (mother) at diagnosis, week 32 and week 36 Concentration differences in glucagon like peptide 1 (GLP-1) (mother) at diagnosis, week 32 and week 36 Concentration differences in c-peptide (mother) at diagnosis, week 32 and week 36 Concentration differences in inflammatory markers (IL-6, IL-10, IL-1α, IFN-γ, TNF-α)(mother) at diagnosis, week 32 and week 36 Concentration differences in glucose independent peptide (GIP) (mother) at diagnosis, week 32 and week 36 Concentration differences in glucagon (mother) at diagnosis, week 32 and week 36 Concentration differences in amino acids (AA) (mother) at diagnosis, week 32 and week 36 Concentration differences in osteocalcin (OCN) (mother) at diagnosis, week 32 and week 36 Concentration differences in progesterone (mother) at diagnosis, week 32 and week 36 Concentration differences in Pro-collagen I, N-term. pro-peptide (PINP) (mother) at diagnosis, week 32 and week 36 Concentration differences in Human chorionic gonadotropin (HCG) (mother) at diagnosis, week 32 and week 36 Concentration differences in glucose (cord blood, offspring) at delivery Concentration differences in lactate (cord blood, offspring) at delivery Head circumference (offspring) at delivery Length (offspring) at delivery number of patients needing early feeding through hospital admission immediately after delivery Number of days admitted immediately after delivery through hospital admission immediately after delivery Number of infants with hypoglycemia at delivery Weight of placenta at delivery Concentration differences in steroid hormone binding protein (SHBP) (mother) at diagnosis, week 32 and week 36 Concentration differences in carboxy-terminal collagen crosslinks (CTx) (mother) at diagnosis, week 32 and week 36 Resting energy expenditure (REE) (Resting Metabolic Rate) Performed for 20 minutes Indirect calorimetry
Body Mass Index at diagnosis, week 32 and week 36 weight and height will be combined to report BMI in kg/m\^2
Blood pressure at diagnosis, week 32 and week 36 Systolic and diastolic blood pressure
Concentration differences in IGF-binding protein 3 (IGFBP-3) (mother) at diagnosis, week 32 and week 36 Concentration differences in CRP (mother) at diagnosis, week 32 and week 36
Trial Locations
- Locations (1)
Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital
🇩🇰Aarhus, Denmark