Effect of supplementation of complex milk lipids in pregnancy on fetal growth: results from the Complex Lipids in Mothers and Babies (CLIMB) randomized controlled trial

Background: Gangliosides (GAs) are important for neuronal function and development of the brain, accumulating rapidly in the fetal brain during the last trimester of pregnancy. No study in humans has investigated whether maternal supplementation of GAs during pregnancy has an effect on fetal growth, particularly of the head circumference.

Objective: To evaluate the effect of maternal dietary supplementation of complex milk lipids (CML; gangliosides and phospholipids) from the milk fat globule membrane (MFGM) during pregnancy on fetal growth.

Design: Double-blind three-arm parallel randomized controlled trial of 1500 pregnant women from the Chongqing Municipality of China, recruited between 11 and 14 weeks of pregnancy. Intervention was in the form of supplementation with: control maternal milk formulation containing a minimum of 2 mg GA per serving (4 mg GA per day) versus a CML-enriched (CML-E) maternal milk formulation containing a minimum of 4 mg GA per serving (8 mg GA per day) versus no maternal milk supplementation, but with standard obstetric care including prenatal folic acid supplementation. Main outcomes and measures were ultrasonographically-derived estimates of fetal growth in head circumference (HC) & biparietal diameter (BPD) (primary outcomes); and abdominal circumference (AC), femur length (FL) and estimated fetal weight (EFW) (secondary outcomes) (Clinical trial registry: ChiCTR-IOR-16007700).

Results: Supplementation with CML-E milk had no effects on size at midpregnancy or growth trajectories in any of the fetal biometric dimensions.

Conclusions: Supplementation of CML from the MFGM from the end of the first trimester did not have any effects on fetal growth. The absence of any adverse growth outcomes suggests that maternal MFGM supplementation during pregnancy is safe and using CML-E milk formula can be a method of providing an increased GA and phospholipid supply in early life, which has been associated with neurodevelopmental benefits.

Clinical trial registry: ChiCTR-IOR-16007700 (http://www.chictr.org.cn/enindex.aspx)