An interventional study of Carbohydrate restricted diet and Plant-protein based diet in Diabetes, Gestational, Dietary Modification and Tissue Glucose, sponsored by Helsinki University Central Hospital. Terminated at 1 site in Finland. Open to female participants. Per ClinicalTrials.gov, last updated 2019-10-23.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
eMOM is a randomized, controlled trial to compare the effects of two different dietary interventions during pregnancy. The comparison is based on tissue glucose content (using continuous glucose monitoring system) in pregnant women and on neonate body composition. The recruited women (n=50) have early gestational diabetes mellitus (diagnosed before gestational weeks 13), are obese (BMI >30 kg/m²) and of Caucasian origin. Of the study diets, one is moderately carbohydrate restricted and the other one is high on plant-based protein with an emphasis on healthy Nordic foods. The study has three two-week study periods that are carried out on approximately gestational weeks 13-14 (period I), 24-25 (period II) and 34-35 (period III). Continuous glucose monitoring and other measurements (accelerometer, 3-day food record, gut microbiota, serum lipids, metabolomics, epigenetics etc.) are done during these study periods. At the beginning of the study, before study period I, the participants are randomized to either one of the intervention diets. The first study period consists of a crossover phase in which the participants receive three days' worth of food according to one of the intervention diets (according to the randomization) after which there is a three-day wash-out period. After the wash-out period, the participants receive three days' worth of food according to the other diet. After the first study period, a nutritionist advises the lastly followed intervention diet to the participant and the diet is followed until delivery. To ensure the diet is followed, the participant gets at least five personal counselling sessions, mobile reminders, recipes and food items. After delivery, the infant's body composition, epigenetic markers of cord blood and placenta, gut microbiome and urine metabolomics are measured.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 2 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
Dietary intervention: moderately carbohydrate restricted diet. Parallel phase starts after study period I and the diet is followed until labor.
Other: Carbohydrate restricted diet
Dietary intervention: plant-protein based diet, en emphasis on healthy Nordic foods. Parallel phase starts after study period I and the diet is followed until labor.
Other: Plant-protein based diet
The intervention is implemented by individual face-to-face counseling and mobile-phone counseling by a nutritionist, as well as food bags and recipes suitable for the diet. Targets: fruits and vegetables 500 g/d, fish 2 times/wk, low-fat instead of high-fat meat, red meat ≤ 3 times/wk, low-fat instead of high-fat dairy, high-fibre instead of low-fibre grains, vegetable oils (excluding palm oil and coconut oil) and soft margarine instead of animal fats, moderate reduction of carbohydrates (targets for macronutrients: carbohydrates 40 E%; fat 40 E%; protein 20 E%; dietary fiber 32g, energy intake approximately 2000 kcal/d; protein intake 20 E%; sucrose: \<10 E%; fatty acids: saturated fatty acids \< 10 E%, polyunsaturated fatty acids 5-10 E% and the rest of fat as monounsaturated fatty acids)
The intervention is implemented by individual face-to-face counseling and mobile-phone counseling by a nutritionist, as well as food bags and recipes suitable for the diet. Targets: fruits and vegetables 1 kg/d; fish 3/wk; high-fibre grains, mainly rye, oat and barley; plant protein instead of meat protein; low-fat fermented dairy instead of other dairy; rapeseed oil and rapeseed-based margarine instead of other fats; no carbohydrate restriction (targets for macronutrients: carbohydrates 55 E%; fat 25 E%; protein 20 E%; dietary fiber 36g, energy intake approximately 2000 kcal/d; protein intake 20 E%; sucrose: \<10 E%; fatty acids: saturated fatty acids \< 10 E%, polyunsaturated fatty acids 5-10 E% and the rest of fat as monounsaturated fatty acids)
Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l)
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Time frame: Study period II: during a 14 day period within gestational weeks 23-26
Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l)
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Time frame: Study period III: during a 14 day period within gestational weeks 33-36
Child: Neonatal body fat%
Neonatal body fat%; Measured with PEA POD Cosmed® Infant Body Composition Assessment system
Time frame: one measure within 0-2 days after birth of the child
Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l) in cross-over phase
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Time frame: Study period I: during a 3 day intervention-diet period within gestational weeks 12-15
Mother: Glycaemic variability in crossover phase
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Time frame: Study period I: during a 3 day intervention-diet period within gestational weeks 12-15
Mother: Glycaemic variability
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Time frame: Study period II: during a 14 day period within gestational weeks 23-26
Mother: Glycaemic variability
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Time frame: Study period III: during a 14 day period within gestational weeks 33-36
Percentage of participants on GDM medication
Time frame: Up to 42 gestational weeks
Plan to share: No
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This study is terminated, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Helsinki University Central Hospital