Dietary Management of Gestational Diabetes in Obese Pregnant Women — eMOM  

Body Composition Clinical Trial

Official title: Effects of a Standardized Dietary Intake on Metabolic Outcomes in Obese Pregnant Women With Gestational Diabetes and on Offspring Body Composition

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Birth Weight
• Body Composition
• Diabetes Mellitus
• Diabetes, Gestational
• Dietary Modification
• Tissue Glucose

• NCT number: NCT03542071
• Study type: Interventional
• Source: Helsinki University Central Hospital
• Status: Terminated
• Phase: N/A
• Start date: July 20, 2018
• Completion date: March 23, 2019