Abstract:
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<jats:title>Background</jats:title>
<jats:p>Gangliosides 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.</jats:p>
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<jats:title>Objective</jats:title>
<jats:p>We 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.</jats:p>
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<jats:title>Design</jats:title>
<jats:p>Double-blind parallel randomized controlled trial.</jats:p>
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<jats:title>Methods</jats:title>
<jats:p>1,500 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.</jats:p>
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<jats:title>Results</jats:title>
<jats:p>CML-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.</jats:p>
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<jats:title>Conclusions</jats:title>
<jats:p>Maternal 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.</jats:p>
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<jats:title>Trial registration</jats:title>
<jats:p>Chinese Clinical Trial Register (ChiCTR-IOR-16007700).</jats:p>
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<jats:title>Clinical trial registration</jats:title>
<jats:p>ChiCTR-IOR-16007700; <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.chictr.org.cn/showprojen.aspx?proj=12972" xlink:type="simple">www.chictr.org.cn/showprojen.aspx?proj=12972</jats:ext-link>.</jats:p>
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