Myo-inositol, probiotics and micronutrient supplementation from preconception for glycemia in pregnancy: NiPPeR international multi-center double-blind randomized controlled trial

Accepted/In Press date: 10 February 2021

e-pub ahead of print date: 29 March 2021

Published date: 1 May 2021

Additional Information: Funding Information: The authors thank the participants and their families for their enthu-siastic involvement in the study, the study research staff and hospital clinical staff at participating centers and operational support staff for contributions to the trial, and the members of the independent data monitoring and safety committee for invaluable contributions and for overseeing the conduct of the trial. Funding and Duality of Interest. Public good funding for this investigator-led study is through the Medical Research Council (U.K.) (MRC) 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 for Science, Technology and Research (SG) as part of the Growth, Development and Metabolism Programme of the Singapore Institute for Clinical Sciences (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 was provided by Soci?et?e Des Produits Nestl?e S.A. under a research agreement with the University of Southampton, Auckland UniServices Ltd., Singapore Institute for Clinical Sciences, National University Hospital Singapore PTE Ltd., and NUS. K.M.G. is supported by the National Institute for Health Research (NIHR) (Senior Investigator Award NF-SI-0515-10042), NIHR Southampton 1000DaysPlus Global Nutrition Research Group (17/63/154), and NIHR Southampton Biomedical Research Center (IS-BRC-1215-20004); the British Heart Foundation (RG/15/17/3174); and the European Union (Erasmus 1 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). S.-Y.C. is supported by a Singapore NMRC Clinician Scientist Award (NMRC/CSA-INV/0010/2016). K.M.G., Y.S.C., W.C., and S.-Y.C. report grants from Soci?et?e Des Produits Nestl?e S.A. during the conduct of the study and are co-inventors on patent filings by Nestl?e S.A. relating to the NiPPeR intervention or its components. K.M.G., S.J.B., Y.S.C., W.C., and S.-Y.C. are part of an academic consortium that has received grants from Abbott Nutrition, Nestl?e S.A., Danone, and BenevolentAI Bio Ltd. outside the submitted work. K.M.G. has received reimbursement for speaking at conferences sponsored by companies selling nutritional products. S.-Y.C. has received reimbursement and honoraria into her research funds from Nestl?e S.A. for a half-day consultancy and for speaking at a conference. No other potential conflicts of interest relevant to this article were reported.The funders had no role in the data collection and analysis and the decision to submit for publication. Funding Information: Acknowledgments. The authors thank the participants and their families for their enthusiastic involvement in the study, the study research staff and hospital clinical staff at participating centers and operational support staff for contributions to the trial, and the members of the independent data monitoring and safety committee for invaluable contributions and for overseeing the conduct of the trial. Funding and Duality of Interest. Public good funding for this investigator-led study is through the Medical Research Council (U.K.) (MRC) 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 for Science, Technology and Research (SG) as part of the Growth, Development and Metabolism Programme of the Singapore Institute for Clinical Sciences (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 was provided by Société Des Produits Nestlé S.A. under a research agreement with the University of Southampton, Auckland UniServices Ltd., Singapore Institute for Clinical Sciences, National University Hospital Singapore PTE Ltd., and NUS. K.M.G. is supported by the National Institute for Health Research (NIHR) (Senior Investigator Award NF-SI-0515-10042), NIHR Southampton 1000DaysPlus Global Nutrition Research Group (17/63/154), and NIHR Southampton Biomedical Research Center (IS-BRC-1215-20004); the British Heart Foundation (RG/15/17/3174); and the European Union (Erasmus 1 Programme Early Nutrition eAca-demy Southeast Asia 573651-EPP-1-2016-1-DE-EPPKA2-CBHE-JP and ImpENSA 598488-EPP-1-2018-1-DE-EPPKA2-CBHE-JP). S.-Y.C. is supported by a Singapore NMRC Clinician Scientist Award (NMRC/CSA-INV/0010/2016). K.M.G., Y.S.C., W.C., and S.-Y.C. report grants from Société Des Produits Nestlé S.A. during the conduct of the study and are co-inventors on patent filings by Nestlé S.A. relating to the NiPPeR intervention or its components. K.M.G., S.J.B., Y.S.C., W.C., and S.-Y.C. are part of an academic consortium that has received grants from Abbott Nutrition, Nestlé S.A., Da-none, and BenevolentAI Bio Ltd. outside the submitted work. K.M.G. has received reimbursement for speaking at conferences sponsored by companies selling nutritional products. S.-Y.C. has received reimbursement and honoraria into her research funds from Nestlé S.A. for a half-day consultancy and for speaking at a conference. No other potential conflicts of interest relevant to this article were reported. Publisher Copyright: © 2021 by the American Diabetes Association.

Local EPrints ID: 447043

URI: http://eprints.soton.ac.uk/id/eprint/447043

DOI: doi:10.2337/dc20-2515

ISSN: 1935-5548

PURE UUID: 1a66233b-2266-434b-8f2b-1084346b0d4b

ORCID for Keith Godfrey: orcid.org/0000-0002-4643-0618

ORCID for Sheila Barton: orcid.org/0000-0003-4963-4242

ORCID for Sarah El-Heis: orcid.org/0000-0003-4277-7187

Date deposited: 02 Mar 2021 17:31

Last modified: 17 Mar 2024 06:20