Abstract
BackgroundImproved maternal nutrition and glycaemic control before and during pregnancy are thought to benefit the health of the mother, with consequent benefits for infant body composition and later obesity risk. Maternal insulin resistance and glycaemia around conception and in early pregnancy may be key determinants of maternal physiology and placental function, affecting fetal nutrient supply and maternal-feto-placental communications throughout gestation, with implications for later postnatal health.Methods/designThis double-blind randomised controlled trial will recruit up to 1800 women, aged 18–38 years, who are planning a pregnancy in the United Kingdom (UK), Singapore and New Zealand, with a view to studying 600 pregnancies. The primary outcome is maternal glucose tolerance at 28 weeks’ gestation following an oral glucose tolerance test. Secondary outcomes include metabolic, molecular and health-related outcomes in the mother and offspring, notably infant body composition. Participants will be randomly allocated to receive a twice-daily control nutritional drink, enriched with standard micronutrients, or a twice-daily intervention nutritional drink enriched with additional micronutrients, myo-inositol and probiotics, both demonstrated previously to assist in maintaining healthy glucose metabolism during pregnancy. Myo-inositol is a nutrient that enhances cellular glucose uptake. The additional micronutrients seek to address deficiencies of some B-group vitamins and vitamin D that are both common during pregnancy and that have been associated with maternal dysglycaemia, epigenetic changes and greater offspring adiposity. Women who conceive within a year of starting the nutritional drinks will be followed through pregnancy and studied with their infants at six time points during the first year of life. Blood, urine/stool, hair and cheek swabs will be collected from the mothers for genetic, epigenetic, hormone, nutrient and metabolite measurements, and assessments of the mother’s body composition, anthropometry, health, diet and lifestyle will be made. Infants will also undergo hair, cheek swab, urine and stool sampling for similar biological measurements; infant body composition will be assessed and feeding recorded.DiscussionThere is an increasing focus on the need to optimise maternal nutrition starting prior to conception. This trial will provide evidence on the potential for nutritional interventions beginning prior to conception to promote healthy maternal and offspring outcomes.Trial registrationClinicalTrials.gov, identifier: NCT02509988, Universal Trial Number U1111-1171-8056. Registered on 16 July 2015. This is an academic-led study by the EpiGen Global Research Consortium.
Highlights
Improved maternal nutrition and glycaemic control before and during pregnancy are thought to benefit the health of the mother, with consequent benefits for infant body composition and later obesity risk
This double-blind randomised controlled trial in groups of women from different ethnic groups in the United Kingdom (UK), Singapore and New Zealand is designed to examine the hypothesis that a nutritional drink, commencing before conception and continuing during pregnancy, will assist in the maintenance of healthy glucose metabolism in the mother and promote offspring health
The intervention group will receive a nutritional drink enriched with micronutrients, myo-inositol and probiotics, and the control group will receive a drink enriched with standard micronutrients
Summary
This double-blind randomised controlled trial in groups of women from different ethnic groups in the UK, Singapore and New Zealand is designed to examine the hypothesis that a nutritional drink, commencing before conception and continuing during pregnancy, will assist in the maintenance of healthy glucose metabolism in the mother and promote offspring health. A range of biological samples collected at multiple time points before, during and after pregnancy in the mother and offspring enables a systems biology approach to understanding the complex interaction of factors that determine maternal and infant wellbeing Both individually and collectively, the control and intervention arms will provide extensive information that will deliver new knowledge on how maternal nutrition and metabolic state can promote offspring health.
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