NCT02509988

Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health

Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health "(NiPPeR)"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,729 (actual)
• Sponsor: University of Southampton · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Accepted

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.

Detailed description

It is known 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 optimise preconception nutrition but as yet, limited preconception interventions that are recognized as promoting health for the mother and her child. The Investigators will recruit up to 1800 women, aged 18-38 years, who are planning a pregnancy in the United Kingdom, Singapore and New Zealand with the aim of securing 600 or more pregnancies. The participants will be randomly allocated to receive the standard nutritional drink or the study nutritional drink. Women who conceive between one and twelve months after starting the nutritional drink will be followed through pregnancy and studied with their babies for three years after delivery. Various testing will be carried out at relevant time points. Mothers will undergo blood, urine, hair and cheek swab sampling, dual-energy X-ray absorptiometry (DXA) 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 a DXA scan. Placental, cord and other perinatal tissues/samples will be collected. The data collected will allow identification of 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, enhancing fertility, mood and reproductive outcomes in the mother, and promoting healthy growth, body composition and wellbeing in the children. The effect of the intervention on the primary outcome will be examined in two special interest groups; i) women who are overweight or obese prior to conception \& ii) women with documented evidence of dysglycemia prior to conception.

Conditions

• Hyperglycemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Study nutritional drink	Study nutritional drink containing a mix of micronutrients, probiotics and myo-inositol.
DIETARY_SUPPLEMENT	Standard nutritional drink	Standard nutritional drink containing a mix of micronutrients.

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-10-01
• Completion: 2022-06-01
• First posted: 2015-07-28
• Last updated: 2023-05-15

Locations

3 sites across 3 countries: New Zealand, Singapore, United Kingdom