HyperglycemiaNiPPeRNCT02509988
Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health
A study testing Study nutritional drink and Standard nutritional drink in people with Hyperglycemia, run by University of Southampton at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Study nutritional drink and Standard nutritional drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,729 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jul 2015to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-38 years
- Planning to conceive within 6 months
- Able to provide written, informed consent
- In Singapore: Chinese, Malay and Indian ethnicity or mixed Chinese/Malay/Indian ethnicity
Who cannot join
- Pregnant or lactating at recruitment
- Assisted fertility, apart from those taking clomiphene or letrozole alone
- Pre-existing diabetes (type 1 or type 2)
- Oral or implanted contraception currently or in the last month, or with an Intrauterine Contraceptive Device (IUCD) in situ
- On metformin or systemic steroids currently or in the last month
- Known serious food allergy
Show all 11Show fewer
- Not able to give informed consent
- Women on anticonvulsants (who are treated with high dose B vitamins in pregnancy) currently or in the last month
- On treatment for Human Immunodeficiency Virus (HIV), Hepatitis B or C currently or in the last month
- The partners of the women (over 16 years of age) will also be invited to participate in the study. After having gained written informed consent, fathers will have blood, urine, hair sampling, cheek swabs and body measurements taken and will complete a health and a lifestyle questionnaire at one of the visits during pregnancy.
- The mother will consent for their babies to have body measurements, buccal, hair, stool samples and allergy testing from birth to 3.5 years.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
About this study
Official title: Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health "(NiPPeR)"
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.
Read the 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
- Being tested
- Study nutritional drink, Standard nutritional drink
- Keywords
- Nutrition, Glucose metabolism, Body composition
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study nutritional drinkDietary supplement
Study nutritional drink containing a mix of micronutrients, probiotics and myo-inositol.
Standard nutritional drinkDietary supplement
Standard nutritional drink containing a mix of micronutrients.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (study nutritional drink) | Experimental | Study nutritional drink comes in the form of a sachet to mix with water \& take twice a day (once in the morning and once in the evening).
The drink will be taken before the participant becomes pregnant (for up to 1 year) and throughout pregnancy. Receives: Dietary Supplement: Study nutritional drink |
| Control (standard nutritional drink) | Active comparator | Standard nutritional drink comes in the form of a sachet to mix with water \& take twice a day (once in the morning and once in the evening).
The drink will be taken before the participant becomes pregnant (for up to 1 year) and throughout pregnancy. Receives: Dietary Supplement: Standard nutritional drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance during pregnancy
Measured: Pregnancy Oral Glucose Tolerance Test (OGTT) measurement at 24 - 32 weeks gestation
Secondary outcomes (44)
Duration of gestation
Measured: Up to 43 weeks, derived from estimated date of conception from menstrual and ultrasound scan data and date of delivery
Pregnancy weight gain and body composition
Measured: Up to 36 weeks, between date of first pregnancy visit and late gestation
Postpartum weight retention and body composition
Measured: Up to 2 years, between date of delivery and 6,12 and 24 months postpartum
Change in body composition before, during and after gestation
Measured: Up to 4 years, between preconception, pregnancy and 2 years postpartum
Clinical pregnancy, pregnancy loss and live birth rates, including median time to conception of those who conceive during the treatment period and proportions conceiving within 3 months, 6 months and a year of commencing the NiPPeR drink
Measured: Between recruitment and delivery
Gestational diabetes frequency
Measured: Pregnancy OGTT measurement at 24 - 32 weeks gestation
Hypertensive disorders of pregnancy (pregnancy-induced hypertension and pre-eclampsia/eclampsia)
Measured: Up to 49 weeks, between conception derived from estimated date of conception from menstrual and ultrasound scan data and date of delivery, and up to 6 weeks after delivery
Nausea and vomiting frequency
Measured: Up to 36 weeks, between 7 weeks of gestation and delivery
Other antenatal, perinatal and postnatal complications
Measured: Up to 49 weeks, between conception from estimated date of conception derived from menstrual and ultrasound scan data, and up to 6 weeks after delivery
Preconception and antenatal maternal wellbeing/mood (Edinburgh Post-natal Depression Scale and State-Trait Anxiety Inventory)
Measured: Up to 2 years, between preconception and delivery
Postnatal maternal wellbeing/mood (Edinburgh Post-natal Depression Scale and State-Trait Anxiety Inventory)
Measured: Up to 52 weeks, between date of delivery and infant age 1 year
Mode of labour onset and delivery
Measured: Delivery
Neonatal complications and admission to neonatal care facilities
Measured: Up to 4 weeks post-delivery
Preconception maternal micronutrient status (blood analysis)
Measured: Date of second preconception visit up to 1 year before pregnancy
Antenatal maternal micronutrient status (blood analysis)
Measured: Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
Preconception maternal gut microbiota composition and activity profile (analysis of sequencing and transcription data)
Measured: Up to 6 weeks from the start of intervention, date of preconception visit 2 which is up to 1 year before pregnancy
Antenatal and postnatal maternal gut and epithelial microbiota composition profile (analysis of sequencing data)
Measured: Up to 18 months, between 7 weeks gestation and post-delivery visits
Maternal preconception biochemical, metabolic and molecular profiles
Measured: Up to 6 weeks from the start of intervention, date of second preconception visit which is up to 1 year before pregnancy
Maternal antenatal biochemical, metabolic and molecular profiles
Measured: Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
Placental and cord tissue, and their cellular derivatives: biochemical, metabolic and molecular profiles
Measured: Birth
Maternal postnatal biochemical, metabolic and molecular profiles
Measured: 6 months after delivery
Maternal preconception epigenetic profile
Measured: Preconception to up to 1 year before pregnancy
Maternal antenatal epigenetic profile
Measured: Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
Maternal postnatal epigenetic profile
Measured: 6 months after delivery
Breast milk macronutrient profile (subsample)
Measured: Up to 1 year, between date of delivery and 1 year postpartum
Breast milk micronutrient profile (subsample)
Measured: Up to 1 year, between date of delivery and 1 year postpartum
Breast milk immune factor profile (subsample)
Measured: Up to 1 year, between date of delivery and 1 year postpartum
Breast milk epigenetic profile (subsample)
Measured: Up to 1 year, between date of delivery and 1 year postpartum
Breast milk biochemical, metabolic, microbiome and molecular profiles (subsample)
Measured: Up to 1 year, between date of delivery and 1 year postpartum
Healthy lactogenesis
Measured: Up to 1 year, between date of delivery and 1 year postpartum
Maternal and infant transcriptomics (including of breastmilk)
Measured: Up to 34 months, between preconception, pregnancy and 1 year postpartum
Intrauterine growth and wellbeing as assessed by antenatal serial ultrasound scans
Measured: Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
Offspring birthweight and size at birth
Measured: At birth
Offspring size for gestational age at birth, less than the 10th, 10th - 90th, and above the 90th percentiles for gestational age
Measured: At birth
Offspring size for gestational age and sex at birth (percentile and standard deviation scores)
Measured: At birth
Offspring adiposity (skinfold thicknesses, regional, total and percentage fat mass)
Measured: Up to 3.5 years, between date of delivery and 3.5 years postpartum
Adiposity gain, body composition and linear growth during infancy and childhood
Measured: Up to 3.5 years, from birth to infant age 3.5 years
Cord blood C-peptide
Measured: At delivery
Offspring cardiometabolic profile
Measured: Up to 3.5 years, from birth to infant age 3.5 years
Offspring allergic wellbeing
Measured: Up to 3.5 years, from birth to infant age 3.5 years
Offspring biochemical, metabolic and molecular profiles
Measured: Up to 3.5 years, from birth to infant age 3.5 years
Offspring epigenetic profile
Measured: Up to 3.5 years, from birth to infant age 3.5 years
Infant gut microbiota composition and activity
Measured: Up to 3.5 years, from birth to infant age 3.5 years
Influence of parental and offspring genotype, sociodemography, body composition, metabolism, lifestyle and diet on the above primary and secondary outcomes at baseline and with the intervention
Measured: Up to 5.5 years, between preconception, pregnancy and 3.5 years postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2018
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,729 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- National University Hospital, Singapore, Auckland UniServices Ltd., Institute for Human Development and Potential (IHDP), Singapore, National University of Singapore, Nestec Ltd.
- Responsible party
- Sponsor
- Investigators
- Wayne Cutfield, BHB MB ChB DCH MD FRACP, Principal investigator, The University of AucklandShiao-Yng Chan, MBBChir (UK), FRCOG (UK), PhD, Principal investigator, National University Hospital, SingaporeKeith Godfrey, BM PhD FRCP, Principal investigator, MRC Lifecourse Epidemiology Unit, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509988
- Sponsor's protocol ID
- 13597
- Other IDs
- 34104, 2015/00205, U1111-1171-8056, 2015
- Acronym
- NiPPeR
- Status last verified
- May 2023
- First submitted
- 16 Jul 2015
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Godfrey KM, Cutfield W, Chan SY, Baker PN, Chong YS; NiPPeR Study Group. Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health ("NiPPeR"): study protocol for a randomised controlled trial. Trials. 2017 Mar 20;18(1):131. doi: 10.1186/s13063-017-1875-x.
PubMed 28320484Lai JS, Lim SX, Barton SJ, Tham EH, El-Heis S, Albert BB, Childs CE, Conlon CA, Colega MT, Cox V, Nield H, Loy SL, Cutfield WS, Chong MF, Godfrey KM, Chan SY. Preconception dietary patterns and time-to-conception in the high-income multi-country NiPPeR study. Nutr J. 2026 Jan 23;25(1):23. doi: 10.1186/s12937-026-01283-0.
PubMed 41578268Han SM, Huang F, Derraik JGB, Vickers MH, Devaraj S, Redeuil K, Campos-Gimenez E, Pang WW, Godfrey KM, Chan SY, Thakkar SK, Cutfield WS; NiPPeR Study Group. A nutritional supplement during preconception and pregnancy increases human milk vitamin D but not B-vitamin concentrations. Clin Nutr. 2023 Dec;42(12):2443-2456. doi: 10.1016/j.clnu.2023.09.009. Epub 2023 Oct 5.
PubMed 38411017Lyons-Reid J, Derraik JGB, Kenealy T, Albert BB, Ramos Nieves JM, Monnard CR, Titcombe P, Nield H, Barton SJ, El-Heis S, Tham E, Godfrey KM, Chan SY, Cutfield WS; NiPPeR Study Group. Impact of preconception and antenatal supplementation with myo-inositol, probiotics, and micronutrients on offspring BMI and weight gain over the first 2 years. BMC Med. 2024 Jan 30;22(1):39. doi: 10.1186/s12916-024-03246-w.
PubMed 38287349Godfrey KM, Titcombe P, El-Heis S, Albert BB, Tham EH, Barton SJ, Kenealy T, Chong MF, Nield H, Chong YS, Chan SY, Cutfield WS; NiPPeR Study Group. Maternal B-vitamin and vitamin D status before, during, and after pregnancy and the influence of supplementation preconception and during pregnancy: Prespecified secondary analysis of the NiPPeR double-blind randomized controlled trial. PLoS Med. 2023 Dec 5;20(12):e1004260. doi: 10.1371/journal.pmed.1004260. eCollection 2023 Dec.
PubMed 38051700Han SM, Derraik JGB, Vickers MH, Devaraj S, Huang F, Pang WW, Godfrey KM, Chan SY, Thakkar SK, Cutfield WS; NiPPeR Study Group. A nutritional supplement taken during preconception and pregnancy influences human milk macronutrients in women with overweight/obesity and gestational diabetes mellitus. Front Nutr. 2023 Oct 17;10:1282376. doi: 10.3389/fnut.2023.1282376. eCollection 2023.
PubMed 37915619Lyons-Reid J, Derraik JGB, Kenealy T, Albert BB, Nieves JMR, Monnard CR, Titcombe P, Nield H, Barton SJ, El-Heis S, Tham E, Godfrey KM, Chan SY, Cutfield WS. The effect of a preconception and antenatal nutritional supplement on children's BMI and weight gain over the first 2 years of life: findings from the NiPPeR randomised controlled trial. Lancet Glob Health. 2023 Mar;11 Suppl 1:S11-S12. doi: 10.1016/S2214-109X(23)00095-5.
PubMed 36866469Chan SY, Barton SJ, Loy SL, Chang HF, Titcombe P, Wong JT, Ebreo M, Ong J, Tan KM, Nield H, El-Heis S, Kenealy T, Chong YS, Baker PN, Cutfield WS, Godfrey KM; NiPPeR Study Group. Time-to-conception and clinical pregnancy rate with a myo-inositol, probiotics, and micronutrient supplement: secondary outcomes of the NiPPeR randomized trial. Fertil Steril. 2023 Jun;119(6):1031-1042. doi: 10.1016/j.fertnstert.2023.01.047. Epub 2023 Feb 6.
PubMed 36754158Han SM, Devaraj S, Derraik JGB, Vickers MH, Huang F, Dubascoux S, Godfrey KM, Chan SY, Pang WW, Thakkar SK, Cutfield WS; NiPPeR Study Group. A nutritional supplement containing zinc during preconception and pregnancy increases human milk zinc concentrations. Front Nutr. 2023 Jan 10;9:1034828. doi: 10.3389/fnut.2022.1034828. eCollection 2022.
PubMed 36704795Lim SX, Cox V, Rodrigues N, Colega MT, Barton SJ, Childs CE, Conlon CA, Wall CR, Cutfield WS, Chan SY, Godfrey KM, Chong MF; NiPPeR Study Group. Evaluation of Preconception Dietary Patterns in Women Enrolled in a Multisite Study. Curr Dev Nutr. 2022 Jun 25;6(7):nzac106. doi: 10.1093/cdn/nzac106. eCollection 2022 Jul.
PubMed 36628060Godfrey KM, Barton SJ, El-Heis S, Kenealy T, Nield H, Baker PN, Chong YS, Cutfield W, Chan SY; NiPPeR Study Group. Myo-Inositol, Probiotics, and Micronutrient Supplementation From Preconception for Glycemia in Pregnancy: NiPPeR International Multicenter Double-Blind Randomized Controlled Trial. Diabetes Care. 2021 May;44(5):1091-1099. doi: 10.2337/dc20-2515. Epub 2021 Mar 29.
PubMed 33782086
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health "(NiPPeR)"
- ClinicalTrials.gov ID
- NCT02509988
- Acronym / sponsor ID
- NiPPeR / 13597
- Conditions
- Hyperglycemia
- Keywords
- Nutrition, Glucose metabolism, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,729 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- National University Hospital, Singapore, Auckland UniServices Ltd., Institute for Human Development and Potential (IHDP), Singapore, National University of Singapore, Nestec Ltd.
- Study start
- Jul 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 28 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (study nutritional drink) | Experimental | Dietary Supplement: Study nutritional drinkStudy nutritional drink comes in the form of a sachet to mix with water \& take twice a day (once in the morning and once in the evening). The drink will be taken before the participant becomes pregnant (for up to 1 year) and throughout pregnancy. |
| Control (standard nutritional drink) | Active comparator | Dietary Supplement: Standard nutritional drinkStandard nutritional drink comes in the form of a sachet to mix with water \& take twice a day (once in the morning and once in the evening). The drink will be taken before the participant becomes pregnant (for up to 1 year) and throughout pregnancy. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-38 years
- Planning to conceive within 6 months
- Able to provide written, informed consent
- In Singapore: Chinese, Malay and Indian ethnicity or mixed Chinese/Malay/Indian ethnicity
Key exclusion criteria (11 listed)
- Pregnant or lactating at recruitment
- Assisted fertility, apart from those taking clomiphene or letrozole alone
- Pre-existing diabetes (type 1 or type 2)
- Oral or implanted contraception currently or in the last month, or with an Intrauterine Contraceptive Device (IUCD) in situ
- On metformin or systemic steroids currently or in the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study nutritional drinkStudy nutritional drink containing a mix of micronutrients, probiotics and myo-inositol. | Dietary supplement | Intervention (study nutritional drink) |
| Standard nutritional drinkStandard nutritional drink containing a mix of micronutrients. | Dietary supplement | Control (standard nutritional drink) |
Primary outcome
Glucose tolerance during pregnancy
Time frame: Pregnancy Oral Glucose Tolerance Test (OGTT) measurement at 24 - 32 weeks gestation
44 secondary outcomes
Duration of gestation
Time frame: Up to 43 weeks, derived from estimated date of conception from menstrual and ultrasound scan data and date of delivery
Pregnancy weight gain and body composition
Time frame: Up to 36 weeks, between date of first pregnancy visit and late gestation
Postpartum weight retention and body composition
Time frame: Up to 2 years, between date of delivery and 6,12 and 24 months postpartum
Change in body composition before, during and after gestation
Time frame: Up to 4 years, between preconception, pregnancy and 2 years postpartum
Clinical pregnancy, pregnancy loss and live birth rates, including median time to conception of those who conceive during the treatment period and proportions conceiving within 3 months, 6 months and a year of commencing the NiPPeR drink
Time frame: Between recruitment and delivery
Gestational diabetes frequency
Time frame: Pregnancy OGTT measurement at 24 - 32 weeks gestation
Hypertensive disorders of pregnancy (pregnancy-induced hypertension and pre-eclampsia/eclampsia)
Time frame: Up to 49 weeks, between conception derived from estimated date of conception from menstrual and ultrasound scan data and date of delivery, and up to 6 weeks after delivery
Nausea and vomiting frequency
Time frame: Up to 36 weeks, between 7 weeks of gestation and delivery
Other antenatal, perinatal and postnatal complications
Time frame: Up to 49 weeks, between conception from estimated date of conception derived from menstrual and ultrasound scan data, and up to 6 weeks after delivery
Preconception and antenatal maternal wellbeing/mood (Edinburgh Post-natal Depression Scale and State-Trait Anxiety Inventory)
Time frame: Up to 2 years, between preconception and delivery
Postnatal maternal wellbeing/mood (Edinburgh Post-natal Depression Scale and State-Trait Anxiety Inventory)
Time frame: Up to 52 weeks, between date of delivery and infant age 1 year
Mode of labour onset and delivery
Time frame: Delivery
Neonatal complications and admission to neonatal care facilities
Time frame: Up to 4 weeks post-delivery
Preconception maternal micronutrient status (blood analysis)
Time frame: Date of second preconception visit up to 1 year before pregnancy
Antenatal maternal micronutrient status (blood analysis)
Time frame: Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
Preconception maternal gut microbiota composition and activity profile (analysis of sequencing and transcription data)
Time frame: Up to 6 weeks from the start of intervention, date of preconception visit 2 which is up to 1 year before pregnancy
Antenatal and postnatal maternal gut and epithelial microbiota composition profile (analysis of sequencing data)
Time frame: Up to 18 months, between 7 weeks gestation and post-delivery visits
Maternal preconception biochemical, metabolic and molecular profiles
Time frame: Up to 6 weeks from the start of intervention, date of second preconception visit which is up to 1 year before pregnancy
Maternal antenatal biochemical, metabolic and molecular profiles
Time frame: Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
Placental and cord tissue, and their cellular derivatives: biochemical, metabolic and molecular profiles
Time frame: Birth
Maternal postnatal biochemical, metabolic and molecular profiles
Time frame: 6 months after delivery
Maternal preconception epigenetic profile
Time frame: Preconception to up to 1 year before pregnancy
Maternal antenatal epigenetic profile
Time frame: Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
Maternal postnatal epigenetic profile
Time frame: 6 months after delivery
Breast milk macronutrient profile (subsample)
Time frame: Up to 1 year, between date of delivery and 1 year postpartum
Breast milk micronutrient profile (subsample)
Time frame: Up to 1 year, between date of delivery and 1 year postpartum
Breast milk immune factor profile (subsample)
Time frame: Up to 1 year, between date of delivery and 1 year postpartum
Breast milk epigenetic profile (subsample)
Time frame: Up to 1 year, between date of delivery and 1 year postpartum
Breast milk biochemical, metabolic, microbiome and molecular profiles (subsample)
Time frame: Up to 1 year, between date of delivery and 1 year postpartum
Healthy lactogenesis
Time frame: Up to 1 year, between date of delivery and 1 year postpartum
Maternal and infant transcriptomics (including of breastmilk)
Time frame: Up to 34 months, between preconception, pregnancy and 1 year postpartum
Intrauterine growth and wellbeing as assessed by antenatal serial ultrasound scans
Time frame: Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
Offspring birthweight and size at birth
Time frame: At birth
Offspring size for gestational age at birth, less than the 10th, 10th - 90th, and above the 90th percentiles for gestational age
Time frame: At birth
Offspring size for gestational age and sex at birth (percentile and standard deviation scores)
Time frame: At birth
Offspring adiposity (skinfold thicknesses, regional, total and percentage fat mass)
Time frame: Up to 3.5 years, between date of delivery and 3.5 years postpartum
Adiposity gain, body composition and linear growth during infancy and childhood
Time frame: Up to 3.5 years, from birth to infant age 3.5 years
Cord blood C-peptide
Time frame: At delivery
Offspring cardiometabolic profile
Time frame: Up to 3.5 years, from birth to infant age 3.5 years
Offspring allergic wellbeing
Time frame: Up to 3.5 years, from birth to infant age 3.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Background: PubMed 28320484Godfrey KM, Cutfield W, Chan SY, Baker PN, Chong YS; NiPPeR Study Group. Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health ("NiPPeR"): study protocol for a randomised controlled trial. Trials. 2017 Mar 20;18(1):131. doi: 10.1186/s13063-017-1875-x.
- Derived from this study: PubMed 41578268Lai JS, Lim SX, Barton SJ, Tham EH, El-Heis S, Albert BB, Childs CE, Conlon CA, Colega MT, Cox V, Nield H, Loy SL, Cutfield WS, Chong MF, Godfrey KM, Chan SY. Preconception dietary patterns and time-to-conception in the high-income multi-country NiPPeR study. Nutr J. 2026 Jan 23;25(1):23. doi: 10.1186/s12937-026-01283-0.
- Derived from this study: PubMed 38411017Han SM, Huang F, Derraik JGB, Vickers MH, Devaraj S, Redeuil K, Campos-Gimenez E, Pang WW, Godfrey KM, Chan SY, Thakkar SK, Cutfield WS; NiPPeR Study Group. A nutritional supplement during preconception and pregnancy increases human milk vitamin D but not B-vitamin concentrations. Clin Nutr. 2023 Dec;42(12):2443-2456. doi: 10.1016/j.clnu.2023.09.009. Epub 2023 Oct 5.
- Derived from this study: PubMed 38287349Lyons-Reid J, Derraik JGB, Kenealy T, Albert BB, Ramos Nieves JM, Monnard CR, Titcombe P, Nield H, Barton SJ, El-Heis S, Tham E, Godfrey KM, Chan SY, Cutfield WS; NiPPeR Study Group. Impact of preconception and antenatal supplementation with myo-inositol, probiotics, and micronutrients on offspring BMI and weight gain over the first 2 years. BMC Med. 2024 Jan 30;22(1):39. doi: 10.1186/s12916-024-03246-w.
- Derived from this study: PubMed 38051700Godfrey KM, Titcombe P, El-Heis S, Albert BB, Tham EH, Barton SJ, Kenealy T, Chong MF, Nield H, Chong YS, Chan SY, Cutfield WS; NiPPeR Study Group. Maternal B-vitamin and vitamin D status before, during, and after pregnancy and the influence of supplementation preconception and during pregnancy: Prespecified secondary analysis of the NiPPeR double-blind randomized controlled trial. PLoS Med. 2023 Dec 5;20(12):e1004260. doi: 10.1371/journal.pmed.1004260. eCollection 2023 Dec.
- Derived from this study: PubMed 37915619Han SM, Derraik JGB, Vickers MH, Devaraj S, Huang F, Pang WW, Godfrey KM, Chan SY, Thakkar SK, Cutfield WS; NiPPeR Study Group. A nutritional supplement taken during preconception and pregnancy influences human milk macronutrients in women with overweight/obesity and gestational diabetes mellitus. Front Nutr. 2023 Oct 17;10:1282376. doi: 10.3389/fnut.2023.1282376. eCollection 2023.
- Derived from this study: PubMed 36866469Lyons-Reid J, Derraik JGB, Kenealy T, Albert BB, Nieves JMR, Monnard CR, Titcombe P, Nield H, Barton SJ, El-Heis S, Tham E, Godfrey KM, Chan SY, Cutfield WS. The effect of a preconception and antenatal nutritional supplement on children's BMI and weight gain over the first 2 years of life: findings from the NiPPeR randomised controlled trial. Lancet Glob Health. 2023 Mar;11 Suppl 1:S11-S12. doi: 10.1016/S2214-109X(23)00095-5.
- Derived from this study: PubMed 36754158Chan SY, Barton SJ, Loy SL, Chang HF, Titcombe P, Wong JT, Ebreo M, Ong J, Tan KM, Nield H, El-Heis S, Kenealy T, Chong YS, Baker PN, Cutfield WS, Godfrey KM; NiPPeR Study Group. Time-to-conception and clinical pregnancy rate with a myo-inositol, probiotics, and micronutrient supplement: secondary outcomes of the NiPPeR randomized trial. Fertil Steril. 2023 Jun;119(6):1031-1042. doi: 10.1016/j.fertnstert.2023.01.047. Epub 2023 Feb 6.
- Derived from this study: PubMed 36704795Han SM, Devaraj S, Derraik JGB, Vickers MH, Huang F, Dubascoux S, Godfrey KM, Chan SY, Pang WW, Thakkar SK, Cutfield WS; NiPPeR Study Group. A nutritional supplement containing zinc during preconception and pregnancy increases human milk zinc concentrations. Front Nutr. 2023 Jan 10;9:1034828. doi: 10.3389/fnut.2022.1034828. eCollection 2022.
- Derived from this study: PubMed 36628060Lim SX, Cox V, Rodrigues N, Colega MT, Barton SJ, Childs CE, Conlon CA, Wall CR, Cutfield WS, Chan SY, Godfrey KM, Chong MF; NiPPeR Study Group. Evaluation of Preconception Dietary Patterns in Women Enrolled in a Multisite Study. Curr Dev Nutr. 2022 Jun 25;6(7):nzac106. doi: 10.1093/cdn/nzac106. eCollection 2022 Jul.
- Derived from this study: PubMed 33782086Godfrey KM, Barton SJ, El-Heis S, Kenealy T, Nield H, Baker PN, Chong YS, Cutfield W, Chan SY; NiPPeR Study Group. Myo-Inositol, Probiotics, and Micronutrient Supplementation From Preconception for Glycemia in Pregnancy: NiPPeR International Multicenter Double-Blind Randomized Controlled Trial. Diabetes Care. 2021 May;44(5):1091-1099. doi: 10.2337/dc20-2515. Epub 2021 Mar 29.
- Study WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne Cutfield, BHB MB ChB DCH MD FRACP principal investigator
The University of Auckland
Shiao-Yng Chan, MBBChir (UK), FRCOG (UK), PhD principal investigator
National University Hospital, Singapore
Keith Godfrey, BM PhD FRCP principal investigator
MRC Lifecourse Epidemiology Unit, University of Southampton
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study nutritional drink and Standard nutritional drink in people with Hyperglycemia, run by University of Southampton at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in New Zealand, Singapore, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose tolerance during pregnancy (time frame: Pregnancy Oral Glucose Tolerance Test (OGTT) measurement at 24 - 32 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02509988, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.