NCT03681054: eMOM

Dietary Management of Gestational Diabetes

Active, enrolled NA Last updated 24 September 2025

What this trial tests

NA trial testing Carbohydrate restricted diet in Diabetes, Gestational in 42 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

3 December 2018

Primary endpoint
5 June 2020

30 December 2027

Quick facts

Lead sponsor	Helsinki University Central Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	42
Start date	3 December 2018
Primary completion	5 June 2020
Estimated completion	30 December 2027
Sites	1 location across Finland

Drugs / interventions tested

• Carbohydrate restricted diet
• Plant-protein based diet

Conditions studied

• Diabetes, Gestational — all drugs for Diabetes, Gestational →
• Dietary Modification — all drugs for Dietary Modification →
• Glucose Intolerance During Pregnancy — all drugs for Glucose Intolerance During Pregnancy →
• Body Composition — all drugs for Body Composition →

Sponsor

Helsinki University Central Hospital

Who can join

Eligibility, female only, with Diabetes, Gestational or Dietary Modification. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Short-term effect of plant-based Nordic diet versus carbohydrate-restricted diet on glucose levels in gestational diabetes - the eMOM pilot study.
   Markussen LT, Kivelä J, Lindström J, Ashrafi RA, et al · · 2023 · cited 4× · PMID 37452403 · DOI 10.1186/s40795-023-00744-7
2. Glycemic control in women with GDM: insights from a randomized controlled pilot trial on plant-based Nordic healthy diet versus moderately carbohydrate restricted diet.
   Markussen LT, Kivelä J, Lindström J, Ollikainen M, et al · · 2025 · PMID 39815337 · DOI 10.1186/s40795-024-00988-x
3. Glycemic control in women with GDM: Insights from a randomized controlled pilot trial on plant-based Nordic Healthy diet versus moderately carbohydrate restricted diet
   Markussen LT, Kivelä J, Lindström J, Ollikainen M, et al · · 2023 · DOI 10.21203/rs.3.rs-3705373/v1
4. Short-term effect of plant-based Nordic diet versus carbohydrate-restricted diet on glucose levels in gestational diabetes – the eMOM pilot study
   Markussen LT, Kivelä J, Lindström J, Ashrafi RA, et al · · 2023 · DOI 10.21203/rs.3.rs-2502889/v1