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

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Albert, Benjamin B., Derraik, José G. B., Xia, Yin-Yin, Norris, Tom, Zhang, Ting, Han, Ting-Li, Chang, Chen, Rowan, Angela, Gallier, Sophie, Souza, Renato T., Hammond, Judith J., Zhou, Wei, Zhang, Hua, Qi, Hong-Bo and Baker, Philip N. (2021) Supplementation with milk enriched with complex lipids during pregnancy: A double-blind randomized controlled trial. PLoS One, 16 (2). ISSN 1932-6203

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Abstract

Background 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. Objective 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. Design Double-blind parallel randomized controlled trial. Methods 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. Results 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. Conclusions 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.

Item Type: Article
Additional Information: Data Availability: The clinical data cannot be made available in a public repository according to the strict conditions of the study's ethics approval. Nonetheless, anonymized and unidentifiable data could be made available to other investigators upon request, pending approval from the ethics committee. For any queries, please contact Mr Dean Adam (dean.adam@auckland.ac.nz). Funding: This work was supported by the New Zealand Primary Growth Partnership post-farm gate dairy programme, funded by the New Zealand Ministry for Primary Industries and Fonterra Co-operative Group Ltd. New Zealand. Fonterra Co-operative Group Ltd. provided support in the form of salaries for authors [AR and SG], but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors [AR and SG] are articulated in the ‘author contributions’ section. BBA was supported by a Rutherford Fellowship from the Royal Society of New Zealand and a Maurice & Phyllis Paykel Trust Fellowship.
Uncontrolled Keywords: sdg 3 - good health and well-being ,/dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_being
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Centres > Metabolic Health
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Depositing User: LivePure Connector
Date Deposited: 11 Jun 2025 13:30
Last Modified: 11 Jun 2025 13:30
URI: https://ueaeprints.uea.ac.uk/id/eprint/99465
DOI: 10.1371/journal.pone.0244916

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