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

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.

Associations of Gestational Weight Gain at Different Trimesters with Adverse Pregnancy Outcomes. A Prospective Study of 1273 Subjects

“…This trial was prospectively registered with the Chinese Clinical Trial Register (ChiCTR-IOR-16007700). The CLIMB study included a total of 1500 participants [21]. Women who dropped out of the study (n = 146), terminated their pregnancy (n = 29), miscarried (n = 12), or lost to follow-up (n = 40) were excluded from the analysis.…”

Investigating the impact of oral health on pregnancy and offspring outcomes: protocol for the Lifetime Impact of ORal heAlth (LIORA) cohort study

“…For a type I error of 0.05, a type II error of 0.2 and a power of 0.8, the sample size required is 32. To take into account a 20% loss rate in follow up,21 22 the required sample size increases to 40. With the prevalence of GDM in China estimated to be 17%,23 24 we expect our sample size of 1000 pregnant women will include 170 women with GDM, and, of these, there will be approximately 76 with periodontitis.…”

“…Information to Open access be collected from the women over the three prenatal visits will include past and present medical and health history, pregnancy and sociodemographic factors (age, education, occupation, family), along with lifestyle factors such as smoking and alcohol consumption. 21 25 Clinical assessments will be conducted at each visit, with a range of measurements (weight, height, waist circumference and blood pressure) recorded. Biological samples collected at these visits will include blood, urine, hair, saliva, dental plaque, buccal swabs and fingernail clippings.…”

An Investigation of the Relationship Between Dietary Patterns in Early Pregnancy and Maternal/Infant Health Outcomes in a Chinese Cohort

“…CLIMB participants were eligible for the current study if they completed a food frequency questionnaire (FFQ) at their first visit (between 11 and 14 weeks gestation). The CLIMB study included a total of 1,500 participants and the intervention did not have any significant effect on maternal or infant outcomes, including infant cognitive outcomes (17). The dietary patterns analyzed in the current study were not part of the intervention.…”