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Randomized Controlled Trial
. 2021 Feb 24;16(2):e0244916.
doi: 10.1371/journal.pone.0244916. eCollection 2021.

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

Benjamin B Albert  1 , José G B Derraik  1   2 , Yin-Yin Xia  3 , Tom Norris  4 , Ting Zhang  5 , Ting-Li Han  5   6 , Chen Chang  5   6 , Angela Rowan  7 , Sophie Gallier  7 , Renato T Souza  8 , Judith J Hammond  9 , Wei Zhou  10 , Hua Zhang  5   6 , Hong-Bo Qi  5   6 , Philip N Baker  4   5   6
Affiliations
Randomized Controlled Trial

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

Benjamin B Albert et al. PLoS One. .

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.

Trial registration: Chinese Clinical Trial Register (ChiCTR-IOR-16007700).

Clinical trial registration: ChiCTR-IOR-16007700; www.chictr.org.cn/showprojen.aspx?proj=12972.

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Conflict of interest statement

The design and conception of the study was led by the principal investigators. The funders had no role in data collection, analysis, and interpretation, or decision to publish. When the study was undertaken, AR and SG were employed by Fonterra Co-operative Group Ltd; the other authors have no financial conflicts of interest to disclose that may be relevant to this work. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Flow of participants in the CLIMB trial (Chongqing, China).
See this image and copyright information in PMC

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