The University of Southampton
University of Southampton Institutional Repository

Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health ("NiPPeR"): study protocol for a randomised controlled trial.

Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health ("NiPPeR"): study protocol for a randomised controlled trial.
Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health ("NiPPeR"): study protocol for a randomised controlled trial.
Background
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. 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/design
This 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.

Discussion
There 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.
1745-6215
Godfrey, Keith
0931701e-fe2c-44b5-8f0d-ec5c7477a6fd
Cutfield, Wayne
a01589bd-5b82-49fa-89e1-137e6f59e24d
Chan, Shiao-Yng
3c9d8970-2cc4-430a-86a7-96f6029a5293
Baker, Philip N.
e1cd37f8-ad89-4ec9-852a-0de07468abab
Chong, Yap Seng
7043124b-e892-4d4b-8bb7-6d35ed94e136
Childs, Caroline
ea17ccc1-2eac-4f67-96c7-a0c4d9dfd9c5
NiPPeR Study Group
Godfrey, Keith
0931701e-fe2c-44b5-8f0d-ec5c7477a6fd
Cutfield, Wayne
a01589bd-5b82-49fa-89e1-137e6f59e24d
Chan, Shiao-Yng
3c9d8970-2cc4-430a-86a7-96f6029a5293
Baker, Philip N.
e1cd37f8-ad89-4ec9-852a-0de07468abab
Chong, Yap Seng
7043124b-e892-4d4b-8bb7-6d35ed94e136
Childs, Caroline
ea17ccc1-2eac-4f67-96c7-a0c4d9dfd9c5

Godfrey, Keith, Cutfield, Wayne, Chan, Shiao-Yng, Baker, Philip N. and Chong, Yap Seng , NiPPeR Study Group (2017) Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health ("NiPPeR"): study protocol for a randomised controlled trial. Trials, 18, [131]. (doi:10.1186/s13063-017-1875-x).

Record type: Article

Abstract

Background
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. 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/design
This 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.

Discussion
There 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.

Text
NiPPeR for Trials FINAL updated Revised Feb2017a clean - Accepted Manuscript
Available under License Creative Commons Attribution.
Download (93kB)
Text
NiPPeR for Trials Table 1
Available under License Creative Commons Attribution.
Download (33kB)
Slideshow
NiPPeR BMC Trials paper SPIRIT Figure
Available under License Creative Commons Attribution.
Download (111kB)

More information

Accepted/In Press date: 6 March 2017
e-pub ahead of print date: 20 March 2017
Published date: 20 March 2017
Organisations: Faculty of Medicine, Human Development & Health

Identifiers

Local EPrints ID: 407140
URI: http://eprints.soton.ac.uk/id/eprint/407140
ISSN: 1745-6215
PURE UUID: 11b0ee94-8c3f-46c4-afc8-b8e84fa94e6f
ORCID for Keith Godfrey: ORCID iD orcid.org/0000-0002-4643-0618
ORCID for Caroline Childs: ORCID iD orcid.org/0000-0001-6832-224X

Catalogue record

Date deposited: 30 Mar 2017 01:07
Last modified: 18 Feb 2021 17:11

Export record

Altmetrics

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×