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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02509988
Registration number
NCT02509988
Ethics application status
Date submitted
16/07/2015
Date registered
28/07/2015
Date last updated
15/05/2023
Titles & IDs
Public title
Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health
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Scientific title
Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health "(NiPPeR)"
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Secondary ID [1]
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34104
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Secondary ID [2]
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13597
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Universal Trial Number (UTN)
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Trial acronym
NiPPeR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hyperglycemia
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Condition category
Condition code
Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Study nutritional drink
Treatment: Other - Standard nutritional drink
Experimental: 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.
Active comparator: 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.
Treatment: Other: Study nutritional drink
Study nutritional drink containing a mix of micronutrients, probiotics and myo-inositol.
Treatment: Other: Standard nutritional drink
Standard nutritional drink containing a mix of micronutrients.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Glucose tolerance during pregnancy
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Assessment method [1]
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Timepoint [1]
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Pregnancy Oral Glucose Tolerance Test (OGTT) measurement at 24 - 32 weeks gestation
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Secondary outcome [1]
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Duration of gestation
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Assessment method [1]
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Timepoint [1]
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Up to 43 weeks, derived from estimated date of conception from menstrual and ultrasound scan data and date of delivery
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Secondary outcome [2]
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Pregnancy weight gain and body composition
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Assessment method [2]
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Timepoint [2]
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Up to 36 weeks, between date of first pregnancy visit and late gestation
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Secondary outcome [3]
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Postpartum weight retention and body composition
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Assessment method [3]
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Timepoint [3]
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Up to 2 years, between date of delivery and 6,12 and 24 months postpartum
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Secondary outcome [4]
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Change in body composition before, during and after gestation
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Assessment method [4]
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Timepoint [4]
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Up to 4 years, between preconception, pregnancy and 2 years postpartum
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Secondary outcome [5]
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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
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Assessment method [5]
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Timepoint [5]
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Between recruitment and delivery
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Secondary outcome [6]
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Gestational diabetes frequency
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Assessment method [6]
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Timepoint [6]
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Pregnancy OGTT measurement at 24 - 32 weeks gestation
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Secondary outcome [7]
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Hypertensive disorders of pregnancy (pregnancy-induced hypertension and pre-eclampsia/eclampsia)
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Assessment method [7]
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Timepoint [7]
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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
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Secondary outcome [8]
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Nausea and vomiting frequency
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Assessment method [8]
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Timepoint [8]
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Up to 36 weeks, between 7 weeks of gestation and delivery
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Secondary outcome [9]
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Other antenatal, perinatal and postnatal complications
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Assessment method [9]
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Timepoint [9]
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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
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Secondary outcome [10]
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Preconception and antenatal maternal wellbeing/mood (Edinburgh Post-natal Depression Scale and State-Trait Anxiety Inventory)
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Assessment method [10]
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Timepoint [10]
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Up to 2 years, between preconception and delivery
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Secondary outcome [11]
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Postnatal maternal wellbeing/mood (Edinburgh Post-natal Depression Scale and State-Trait Anxiety Inventory)
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Assessment method [11]
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Timepoint [11]
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Up to 52 weeks, between date of delivery and infant age 1 year
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Secondary outcome [12]
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Mode of labour onset and delivery
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Assessment method [12]
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Timepoint [12]
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Delivery
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Secondary outcome [13]
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Neonatal complications and admission to neonatal care facilities
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Assessment method [13]
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Timepoint [13]
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Up to 4 weeks post-delivery
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Secondary outcome [14]
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Preconception maternal micronutrient status (blood analysis)
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Assessment method [14]
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Timepoint [14]
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Date of second preconception visit up to 1 year before pregnancy
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Secondary outcome [15]
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Antenatal maternal micronutrient status (blood analysis)
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Assessment method [15]
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Timepoint [15]
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Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
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Secondary outcome [16]
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Preconception maternal gut microbiota composition and activity profile (analysis of sequencing and transcription data)
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Assessment method [16]
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Timepoint [16]
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Up to 6 weeks from the start of intervention, date of preconception visit 2 which is up to 1 year before pregnancy
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Secondary outcome [17]
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Antenatal and postnatal maternal gut and epithelial microbiota composition profile (analysis of sequencing data)
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Assessment method [17]
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Timepoint [17]
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Up to 18 months, between 7 weeks gestation and post-delivery visits
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Secondary outcome [18]
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Maternal preconception biochemical, metabolic and molecular profiles
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Assessment method [18]
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Timepoint [18]
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Up to 6 weeks from the start of intervention, date of second preconception visit which is up to 1 year before pregnancy
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Secondary outcome [19]
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Maternal antenatal biochemical, metabolic and molecular profiles
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Assessment method [19]
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Timepoint [19]
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Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
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Secondary outcome [20]
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Placental and cord tissue, and their cellular derivatives: biochemical, metabolic and molecular profiles
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Assessment method [20]
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Timepoint [20]
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Birth
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Secondary outcome [21]
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Maternal postnatal biochemical, metabolic and molecular profiles
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Assessment method [21]
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Timepoint [21]
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6 months after delivery
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Secondary outcome [22]
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Maternal preconception epigenetic profile
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Assessment method [22]
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Timepoint [22]
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Preconception to up to 1 year before pregnancy
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Secondary outcome [23]
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Maternal antenatal epigenetic profile
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Assessment method [23]
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Timepoint [23]
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Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
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Secondary outcome [24]
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Maternal postnatal epigenetic profile
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Assessment method [24]
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Timepoint [24]
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6 months after delivery
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Secondary outcome [25]
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Breast milk macronutrient profile (subsample)
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Assessment method [25]
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Timepoint [25]
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Up to 1 year, between date of delivery and 1 year postpartum
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Secondary outcome [26]
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Breast milk micronutrient profile (subsample)
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Assessment method [26]
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Timepoint [26]
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Up to 1 year, between date of delivery and 1 year postpartum
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Secondary outcome [27]
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Breast milk immune factor profile (subsample)
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Assessment method [27]
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Timepoint [27]
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Up to 1 year, between date of delivery and 1 year postpartum
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Secondary outcome [28]
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Breast milk epigenetic profile (subsample)
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Assessment method [28]
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Timepoint [28]
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Up to 1 year, between date of delivery and 1 year postpartum
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Secondary outcome [29]
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Breast milk biochemical, metabolic, microbiome and molecular profiles (subsample)
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Assessment method [29]
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Timepoint [29]
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Up to 1 year, between date of delivery and 1 year postpartum
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Secondary outcome [30]
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Healthy lactogenesis
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Assessment method [30]
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Timepoint [30]
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Up to 1 year, between date of delivery and 1 year postpartum
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Secondary outcome [31]
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Maternal and infant transcriptomics (including of breastmilk)
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Assessment method [31]
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Timepoint [31]
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Up to 34 months, between preconception, pregnancy and 1 year postpartum
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Secondary outcome [32]
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Intrauterine growth and wellbeing as assessed by antenatal serial ultrasound scans
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Assessment method [32]
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Timepoint [32]
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Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
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Secondary outcome [33]
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Offspring birthweight and size at birth
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Assessment method [33]
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Timepoint [33]
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At birth
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Secondary outcome [34]
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Offspring size for gestational age at birth, less than the 10th, 10th - 90th, and above the 90th percentiles for gestational age
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Assessment method [34]
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Timepoint [34]
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At birth
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Secondary outcome [35]
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Offspring size for gestational age and sex at birth (percentile and standard deviation scores)
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Assessment method [35]
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Timepoint [35]
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At birth
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Secondary outcome [36]
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Offspring adiposity (skinfold thicknesses, regional, total and percentage fat mass)
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Assessment method [36]
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Timepoint [36]
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Up to 3.5 years, between date of delivery and 3.5 years postpartum
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Secondary outcome [37]
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Adiposity gain, body composition and linear growth during infancy and childhood
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Assessment method [37]
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Timepoint [37]
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Up to 3.5 years, from birth to infant age 3.5 years
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Secondary outcome [38]
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Cord blood C-peptide
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Assessment method [38]
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Timepoint [38]
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At delivery
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Secondary outcome [39]
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Offspring cardiometabolic profile
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Assessment method [39]
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Timepoint [39]
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Up to 3.5 years, from birth to infant age 3.5 years
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Secondary outcome [40]
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Offspring allergic wellbeing
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Assessment method [40]
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Timepoint [40]
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Up to 3.5 years, from birth to infant age 3.5 years
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Secondary outcome [41]
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Offspring biochemical, metabolic and molecular profiles
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Assessment method [41]
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Timepoint [41]
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Up to 3.5 years, from birth to infant age 3.5 years
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Secondary outcome [42]
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Offspring epigenetic profile
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Assessment method [42]
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Timepoint [42]
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Up to 3.5 years, from birth to infant age 3.5 years
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Secondary outcome [43]
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Infant gut microbiota composition and activity
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Assessment method [43]
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Timepoint [43]
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Up to 3.5 years, from birth to infant age 3.5 years
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Secondary outcome [44]
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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
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Assessment method [44]
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Timepoint [44]
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Up to 5.5 years, between preconception, pregnancy and 3.5 years postpartum
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Eligibility
Key inclusion criteria
* 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
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Minimum age
18
Years
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Maximum age
38
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* 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
* 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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2022
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Sample size
Target
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Accrual to date
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Final
1729
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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Singapore
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State/province [2]
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Singapore
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Country [3]
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United Kingdom
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State/province [3]
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Hampshire
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Southampton
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National University Hospital, Singapore
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/industry
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Name [2]
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Auckland UniServices Ltd.
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Institute for Human Development and Potential (IHDP), Singapore
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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National University of Singapore
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Address [4]
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Country [4]
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Other collaborator category [5]
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Commercial sector/industry
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Name [5]
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Nestec Ltd.
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Address [5]
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Country [5]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT02509988
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Trial related presentations / 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Wayne Cutfield, BHB MB ChB DCH MD FRACP
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Address
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The University of Auckland
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Country
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Phone
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Fax
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0
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02509988
Download to PDF