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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
Scientific title
Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health "(NiPPeR)"
Secondary ID [1] 0 0
34104
Secondary ID [2] 0 0
13597
Universal Trial Number (UTN)
Trial acronym
NiPPeR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperglycemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glucose tolerance during pregnancy
Timepoint [1] 0 0
Pregnancy Oral Glucose Tolerance Test (OGTT) measurement at 24 - 32 weeks gestation
Secondary outcome [1] 0 0
Duration of gestation
Timepoint [1] 0 0
Up to 43 weeks, derived from estimated date of conception from menstrual and ultrasound scan data and date of delivery
Secondary outcome [2] 0 0
Pregnancy weight gain and body composition
Timepoint [2] 0 0
Up to 36 weeks, between date of first pregnancy visit and late gestation
Secondary outcome [3] 0 0
Postpartum weight retention and body composition
Timepoint [3] 0 0
Up to 2 years, between date of delivery and 6,12 and 24 months postpartum
Secondary outcome [4] 0 0
Change in body composition before, during and after gestation
Timepoint [4] 0 0
Up to 4 years, between preconception, pregnancy and 2 years postpartum
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Between recruitment and delivery
Secondary outcome [6] 0 0
Gestational diabetes frequency
Timepoint [6] 0 0
Pregnancy OGTT measurement at 24 - 32 weeks gestation
Secondary outcome [7] 0 0
Hypertensive disorders of pregnancy (pregnancy-induced hypertension and pre-eclampsia/eclampsia)
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Nausea and vomiting frequency
Timepoint [8] 0 0
Up to 36 weeks, between 7 weeks of gestation and delivery
Secondary outcome [9] 0 0
Other antenatal, perinatal and postnatal complications
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
Preconception and antenatal maternal wellbeing/mood (Edinburgh Post-natal Depression Scale and State-Trait Anxiety Inventory)
Timepoint [10] 0 0
Up to 2 years, between preconception and delivery
Secondary outcome [11] 0 0
Postnatal maternal wellbeing/mood (Edinburgh Post-natal Depression Scale and State-Trait Anxiety Inventory)
Timepoint [11] 0 0
Up to 52 weeks, between date of delivery and infant age 1 year
Secondary outcome [12] 0 0
Mode of labour onset and delivery
Timepoint [12] 0 0
Delivery
Secondary outcome [13] 0 0
Neonatal complications and admission to neonatal care facilities
Timepoint [13] 0 0
Up to 4 weeks post-delivery
Secondary outcome [14] 0 0
Preconception maternal micronutrient status (blood analysis)
Timepoint [14] 0 0
Date of second preconception visit up to 1 year before pregnancy
Secondary outcome [15] 0 0
Antenatal maternal micronutrient status (blood analysis)
Timepoint [15] 0 0
Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
Secondary outcome [16] 0 0
Preconception maternal gut microbiota composition and activity profile (analysis of sequencing and transcription data)
Timepoint [16] 0 0
Up to 6 weeks from the start of intervention, date of preconception visit 2 which is up to 1 year before pregnancy
Secondary outcome [17] 0 0
Antenatal and postnatal maternal gut and epithelial microbiota composition profile (analysis of sequencing data)
Timepoint [17] 0 0
Up to 18 months, between 7 weeks gestation and post-delivery visits
Secondary outcome [18] 0 0
Maternal preconception biochemical, metabolic and molecular profiles
Timepoint [18] 0 0
Up to 6 weeks from the start of intervention, date of second preconception visit which is up to 1 year before pregnancy
Secondary outcome [19] 0 0
Maternal antenatal biochemical, metabolic and molecular profiles
Timepoint [19] 0 0
Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
Secondary outcome [20] 0 0
Placental and cord tissue, and their cellular derivatives: biochemical, metabolic and molecular profiles
Timepoint [20] 0 0
Birth
Secondary outcome [21] 0 0
Maternal postnatal biochemical, metabolic and molecular profiles
Timepoint [21] 0 0
6 months after delivery
Secondary outcome [22] 0 0
Maternal preconception epigenetic profile
Timepoint [22] 0 0
Preconception to up to 1 year before pregnancy
Secondary outcome [23] 0 0
Maternal antenatal epigenetic profile
Timepoint [23] 0 0
Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
Secondary outcome [24] 0 0
Maternal postnatal epigenetic profile
Timepoint [24] 0 0
6 months after delivery
Secondary outcome [25] 0 0
Breast milk macronutrient profile (subsample)
Timepoint [25] 0 0
Up to 1 year, between date of delivery and 1 year postpartum
Secondary outcome [26] 0 0
Breast milk micronutrient profile (subsample)
Timepoint [26] 0 0
Up to 1 year, between date of delivery and 1 year postpartum
Secondary outcome [27] 0 0
Breast milk immune factor profile (subsample)
Timepoint [27] 0 0
Up to 1 year, between date of delivery and 1 year postpartum
Secondary outcome [28] 0 0
Breast milk epigenetic profile (subsample)
Timepoint [28] 0 0
Up to 1 year, between date of delivery and 1 year postpartum
Secondary outcome [29] 0 0
Breast milk biochemical, metabolic, microbiome and molecular profiles (subsample)
Timepoint [29] 0 0
Up to 1 year, between date of delivery and 1 year postpartum
Secondary outcome [30] 0 0
Healthy lactogenesis
Timepoint [30] 0 0
Up to 1 year, between date of delivery and 1 year postpartum
Secondary outcome [31] 0 0
Maternal and infant transcriptomics (including of breastmilk)
Timepoint [31] 0 0
Up to 34 months, between preconception, pregnancy and 1 year postpartum
Secondary outcome [32] 0 0
Intrauterine growth and wellbeing as assessed by antenatal serial ultrasound scans
Timepoint [32] 0 0
Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation
Secondary outcome [33] 0 0
Offspring birthweight and size at birth
Timepoint [33] 0 0
At birth
Secondary outcome [34] 0 0
Offspring size for gestational age at birth, less than the 10th, 10th - 90th, and above the 90th percentiles for gestational age
Timepoint [34] 0 0
At birth
Secondary outcome [35] 0 0
Offspring size for gestational age and sex at birth (percentile and standard deviation scores)
Timepoint [35] 0 0
At birth
Secondary outcome [36] 0 0
Offspring adiposity (skinfold thicknesses, regional, total and percentage fat mass)
Timepoint [36] 0 0
Up to 3.5 years, between date of delivery and 3.5 years postpartum
Secondary outcome [37] 0 0
Adiposity gain, body composition and linear growth during infancy and childhood
Timepoint [37] 0 0
Up to 3.5 years, from birth to infant age 3.5 years
Secondary outcome [38] 0 0
Cord blood C-peptide
Timepoint [38] 0 0
At delivery
Secondary outcome [39] 0 0
Offspring cardiometabolic profile
Timepoint [39] 0 0
Up to 3.5 years, from birth to infant age 3.5 years
Secondary outcome [40] 0 0
Offspring allergic wellbeing
Timepoint [40] 0 0
Up to 3.5 years, from birth to infant age 3.5 years
Secondary outcome [41] 0 0
Offspring biochemical, metabolic and molecular profiles
Timepoint [41] 0 0
Up to 3.5 years, from birth to infant age 3.5 years
Secondary outcome [42] 0 0
Offspring epigenetic profile
Timepoint [42] 0 0
Up to 3.5 years, from birth to infant age 3.5 years
Secondary outcome [43] 0 0
Infant gut microbiota composition and activity
Timepoint [43] 0 0
Up to 3.5 years, from birth to infant age 3.5 years
Secondary outcome [44] 0 0
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
Timepoint [44] 0 0
Up to 5.5 years, between preconception, pregnancy and 3.5 years postpartum

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
Minimum age
18 Years
Maximum age
38 Years
Sex
Females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2022
Sample size
Target
Accrual to date
Final
1729
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
Singapore
State/province [2] 0 0
Singapore
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Hampshire

Funding & Sponsors
Primary sponsor type
Other
Name
University of Southampton
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National University Hospital, Singapore
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Auckland UniServices Ltd.
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Institute for Human Development and Potential (IHDP), Singapore
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
National University of Singapore
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Commercial sector/industry
Name [5] 0 0
Nestec Ltd.
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02509988
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.
Public notes

Contacts
Principal investigator
Name 0 0
Wayne Cutfield, BHB MB ChB DCH MD FRACP
Address 0 0
The University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02509988