Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health
NCT ID: NCT02509988
Last Updated: 2023-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1729 participants
INTERVENTIONAL
2015-07-31
2022-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Intervention (study nutritional drink)
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.
Study nutritional drink
Study nutritional drink containing a mix of micronutrients, probiotics and myo-inositol.
Control (standard nutritional drink)
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.
Standard nutritional drink
Standard nutritional drink containing a mix of micronutrients.
Interventions
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Study nutritional drink
Study nutritional drink containing a mix of micronutrients, probiotics and myo-inositol.
Standard nutritional drink
Standard nutritional drink containing a mix of micronutrients.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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.
18 Years
38 Years
FEMALE
Yes
Sponsors
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National University Hospital, Singapore
OTHER
Auckland UniServices Ltd.
INDUSTRY
Institute for Human Development and Potential (IHDP), Singapore
OTHER
National University of Singapore
OTHER
Nestec Ltd.
INDUSTRY
University of Southampton
OTHER
Responsible Party
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Principal Investigators
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Wayne Cutfield, BHB MB ChB DCH MD FRACP
Role: PRINCIPAL_INVESTIGATOR
The University of Auckland
Shiao-Yng Chan, MBBChir (UK), FRCOG (UK), PhD
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Keith Godfrey, BM PhD FRCP
Role: PRINCIPAL_INVESTIGATOR
MRC Lifecourse Epidemiology Unit, University of Southampton
Locations
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The University of Auckland
Auckland, , New Zealand
National University Hospital
Singapore, , Singapore
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
Countries
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References
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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.
Han 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.
Lyons-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.
Godfrey 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.
Han 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.
Lyons-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.
Chan 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.
Han 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.
Lim 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.
Godfrey 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.
Related Links
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Study Website
Other Identifiers
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34104
Identifier Type: OTHER
Identifier Source: secondary_id
2015/00205
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1171-8056
Identifier Type: OTHER
Identifier Source: secondary_id
13597
Identifier Type: -
Identifier Source: org_study_id
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