Clinical trial

Dietary Management of Gestational Diabetes

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT03681054

Active, not recruitingNot applicableInterventional

What this study is about

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=60) have been diagnosed with gestational diabetes mellitus, and are 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 two two-week study periods that are carried out on approximately gestational weeks 24-28 (period I) and 34-36 (period II). 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 participants gets at least three personal face-to-face counseling sessions, phone calls, 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

AgeNot listed to Not listed

SexFemale

Healthy volunteersAccepted

ConditionDiabetes, Gestational, Dietary Modification, Glucose Intolerance During Pregnancy, Body Composition, Birth Weight

Full registry criteria

Inclusion Criteria: \- Gestational diabetes at enrollment Exclusion Criteria: * Gestational weeks exceed 28+6 * Multiple pregnancy * Food allergies or restrictions (other than lactose intolerance) * Mother's or father's ethnic background other than Caucasian * Type 1 or type 2 diabetes * Medication which affects glucose metabolism * Cholesterol medication * Drug or alcohol abuse * Psychiatric illness which affects participation in the study * Factors hampering communication (e.g. lack of Finnish skills)

Treatments and study arms

Carbohydrate restricted diet

Other

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)

Plant-protein based diet

Other

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 50 E%; fat 30 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)

Primary outcomes

Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l) in cross-over phaseStudy period I: during a 3 day intervention-diet period within gestational weeks 24-28

Measured with FreeStyle®Libre, Continuous Glucose Monitoring system

Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l)Study period II: during a 14 day period within gestational weeks 34-36

Measured with FreeStyle®Libre, Continuous Glucose Monitoring system

Child: Neonatal body fat%one measure within 0-2 days after birth of the child

Neonatal body fat%; Measured with PEA POD Cosmed® Infant Body Composition Assessment system

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Helsinki university central hospital🇫🇮 Helsinki, Finland

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