NiPPeR
Research type
Research Study
Full title
Nutritional Intervention Preconception & during Pregnancy to maintain healthy glucosE metabolism & offspRing health.
IRAS ID
172958
Contact name
Keith Godfrey
Contact email
Sponsor organisation
University of Southamoton
Duration of Study in the UK
4 years, 7 months, 31 days
Research summary
The study aims to assess whether a nutritional drink taken before conception and continuing through pregnancy, assists in the maintenance of healthy glucose metabolism in the mother and promotes offspring health. We know that maternal insulin resistance and high blood glucose levels in early pregnancy alter the functioning of the placenta in ways that persistently affect the supply of nutrients and fat in the unborn baby. There is an increasing focus on the need to optimize pre-conception nutrition, but as yet there are no pre-conception interventions that are recognized as promoting health for the mother and her child.
We will recruit 1800 women, aged 18-38 years, who are planning a pregnancy in the UK, Singapore and New Zealand. They will be randomly allocated to receive a standard nutritional drink or one containing micronutrients (vitamins B2, B6, B12 and D, zinc), myo-inositol (naturally produced in the body but gut microbes from dietary fibres) and a probiotic (gut microbes). Women who conceive between one and twelve months after starting the nutritional drink will be followed through pregnancy and studied with their babies for the first year after delivery . Various testing will be carried out at relevant time points. Mothers will undergo blood, urine, hair and cheek swab sampling and DXA and MRI scans along with body measurements and health and lifestyle questionnaires. Infants will undergo hair, cheek swab, urine and stool sampling along with body measurements, measurements of body composition and DXA scan. The primary outcome will be the maintenance of healthy glucose tolerance during pregnancy.
The data collected will allow us to identify the contributions of nutritional and lifestyle factors, social and economic status, ethnicity, genetics and metabolomics and gut microbes to maintaining healthy glucose metabolism in pregnancy and promoting healthy growth, body composition and wellbeing in the children
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
15/SC/0142
Date of REC Opinion
22 Apr 2015
REC opinion
Further Information Favourable Opinion