PLoS ONE (Jan 2021)

Supplementation with milk enriched with complex lipids during pregnancy: A double-blind randomized controlled trial.

  • Benjamin B Albert,
  • José G B Derraik,
  • Yin-Yin Xia,
  • Tom Norris,
  • Ting Zhang,
  • Ting-Li Han,
  • Chen Chang,
  • Angela Rowan,
  • Sophie Gallier,
  • Renato T Souza,
  • Judith J Hammond,
  • Wei Zhou,
  • Hua Zhang,
  • Hong-Bo Qi,
  • Philip N Baker

DOI
https://doi.org/10.1371/journal.pone.0244916
Journal volume & issue
Vol. 16, no. 2
p. e0244916

Abstract

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BackgroundGangliosides are a class of sphingolipids that are present in the cell membranes of vertebrates. Gangliosides influence a broad range of cellular processes through effects on signal transduction, being found abundantly in the brain, and having a role in neurodevelopment.ObjectiveWe aimed to assess the effects of maternal daily consumption of ganglioside-enriched milk vs non-enriched milk and a non-supplemented group of pregnant women on maternal ganglioside levels and pregnancy outcomes.DesignDouble-blind parallel randomized controlled trial.Methods1,500 women aged 20-40 years were recruited in Chongqing (China) between 11 and 14 weeks of a singleton pregnancy, and randomized into three groups: Control-received standard powdered milk formulation (≥4 mg gangliosides/day); Complex milk lipid-enhanced (CML-E) group-same formulation enriched with complex milk lipids (≥8 mg gangliosides/day) from milk fat globule membrane; Reference-received no milk. Serum ganglioside levels were measured in a randomly selected subsample of 250 women per group.ResultsCML-E milk was associated with marginally greater total gangliosides levels in maternal serum compared to Control (13.02 vs 12.69 μg/ml; p = 0.034) but not to Reference group. CML-E milk did not affect cord blood ganglioside levels. Among the 1500 women, CML-E milk consumption was associated with a lower rate of gestational diabetes mellitus than control milk [relative risk 0.80 (95% CI 0.64, 0.99)], but which was not different to the Reference group. CML-E milk supplementation had no other effects on maternal or newborn health.ConclusionsMaternal supplementation with milk fat globule membrane, as a source of gangliosides, was not associated with any adverse health outcomes, and did not increase serum gangliosides compared with the non-supplemented reference group.Trial registrationChinese Clinical Trial Register (ChiCTR-IOR-16007700).Clinical trial registrationChiCTR-IOR-16007700; www.chictr.org.cn/showprojen.aspx?proj=12972.