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Myo-Inositol, Probiotics, and Micronutrient Supplementation From Preconception for Glycemia in Pregnancy: NiPPeR International Multicenter Double-Blind Randomized Controlled Trial

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posted on 26.03.2021, 06:10 by Keith M Godfrey, Sheila J Barton, Sarah El-Heis, Timothy Kenealy, Heidi Nield, Philip N Baker, Yap Seng Chong, Wayne Cutfield, Shiao-Yng Chan, NiPPeR Study Group
Objective: Better preconception metabolic and nutritional health are hypothesized to promote gestational normoglycemia and reduce preterm birth, but evidence supporting improved outcomes with nutritional supplementation starting preconception is limited.

Research Design and Methods: Double-blind randomized controlled trial recruited from the community 1729 UK, Singapore and New Zealand women aged 18-38 years planning conception. We investigated if a nutritional formulation containing myo-inositol, probiotics and multiple micronutrients (intervention), compared with a standard micronutrient supplement (control), taken preconception and throughout pregnancy, could improve pregnancy outcomes. The primary outcome was combined fasting, 1-hour and 2-hour post-load glycemia (28 weeks’ gestation oral glucose tolerance test).

Results: Between 2015-2017, participants were randomized to control (n=859) or intervention (n=870); 585 conceived within 1-year and completed the primary outcome (295 intervention, 290 control). In an intention-to-treat analysis adjusting for site, ethnicity and preconception glycemia with pre-specified p<0.017 for multiplicity, there were no differences in gestational fasting, 1-hour and 2-hour glycemia between groups (β [95%CI] loge mmol/L intervention versus control: -0·004 [-0·018, 0·011], 0·025 [-0·014, 0·064], 0·040 [0·004, 0·077], respectively). Between the intervention and control groups there were no significant differences in gestational diabetes (24·8% versus 22·6%, adjusted risk ratio aRR=1·22 [0·92, 1·62]), birthweight (adjusted β=0·05kg [-0·03, 0·13]), or gestational age at birth (mean 39.3 versus 39.2 weeks, adjusted β=0·20 [-0·06, 0·46]), but there were fewer preterm births (5·8% versus 9·2%, aRR=0·43 [0·22, 0·82]) adjusting for pre-specified covariates.

Conclusions: Supplementation with myo-inositol, probiotics and micronutrients preconception and in pregnancy did not lower gestational glycemia, but did reduce preterm birth.


Funding

Public good funding for this investigator-led study is through the UK Medical Research Council (as part of an MRC award to the MRC Lifecourse Epidemiology Unit (MC_UU_12011/4)); the Singapore National Research Foundation, National Medical Research Council (NMRC, NMRC/TCR/012-NUHS/2014); the National University of Singapore (NUS) and the Agency of Science, Technology and Research (as part of the Growth, Development and Metabolism Programme of the Singapore Institute for Clinical Sciences (SICS) (H17/01/a0/005); and as part of Gravida, a New Zealand Government Centre of Research Excellence. Funding for provision of the intervention and control drinks and to cover aspects of the fieldwork for the study has been provided by Société Des Produits Nestlé S.A under a Research Agreement with the University of Southampton, Auckland UniServices Ltd, SICS, National University Hospital Singapore PTE Ltd and NUS. KMG is supported by the National Institute for Health Research (NIHR Senior Investigator (NF-SI-0515-10042), NIHR Southampton 1000DaysPlus Global Nutrition Research Group (17/63/154) and NIHR Southampton Biomedical Research Center (IS-BRC-1215-20004)), British Heart Foundation (RG/15/17/3174) and the European Union (Erasmus+ Programme Early Nutrition eAcademy Southeast Asia-573651-EPP-1-2016-1-DE-EPPKA2-CBHE-JP and ImpENSA 598488-EPP-1-2018-1-DE-EPPKA2-CBHE-JP). SYC is supported by a Singapore NMRC Clinician Scientist Award (NMRC/CSA-INV/0010/2016). The funders had no role in the data collection and analysis, and the decision to submit for publication.

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