NiPPeR Clinical Trial
The collaboration between EpiGen and Société des Produits Nestlé SA in areas related to pregnancy, infancy and childhood growth and metabolic health has led to a randomised controlled trial at three sites (Southampton, Auckland, Singapore) of a nutrient intervention starting before conception and extending through pregnancy. This academic-led study has been given the acronym NiPPeR (Nutritional intervention preconception and during pregnancy to maintain healthy glucose metabolism and offspring health). The study started recruitment in August 2015 and recruitment of 1729 participants across the 3 sites has been completed by May 2017.
The study is still, to date, the largest nutritional intervention study starting in women prior to pregnancy with the aim of improving glucose metabolism in pregnancy and body composition in the infants. We are very proud to have completed our recruitment on schedule in May 2017. In total 586 NiPPeR babies have now delivered across the three sites in Southampton, Singapore and Auckland - the last baby was delivered in Singapore on 1st January 2019!
A lot of work is now going on to collate and analyse all the data and samples that our participants and their babies have kindly provided. The whole investigative team remained blinded to the intervention code until the primary outcome analysis on maternal glycemia was completed in mid-2019. We aim to publish the results in prominent journals to have the highest possible impact on clinical care globally. Work on other non-primary outcomes including the effect of the intervention on fertility, breastmilk composition, maternal mood, gut microbiome, infant adiposity and growth, are at advanced stages. Working with the EpiGen Science Management Group, many more studies to address pertinent clinical and research questions on other aspects of maternal and child health are in the pipeline.
The Trial Management Group are increasing publicity of the NiPPeR trial through presentations at upcoming conferences during 2019, namely the Diabetes in Pregnancy meeting in Florence, May 2019, and the International Diabetes Federation conference in South Korea, December 2019.
