NCT02509988

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,729

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

3.3 years

First QC Date

July 16, 2015

Last Update Submit

May 12, 2023

Conditions

Hyperglycemia

Keywords

NutritionGlucose metabolismBody composition

Outcome Measures

Primary Outcomes (1)

  • Glucose tolerance during pregnancy

    Pregnancy Oral Glucose Tolerance Test (OGTT) measurement at 24 - 32 weeks gestation

Secondary Outcomes (44)

  • Duration of gestation

    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

    Up to 36 weeks, between date of first pregnancy visit and late gestation

  • Postpartum weight retention and body composition

    Up to 2 years, between date of delivery and 6,12 and 24 months postpartum

  • Change in body composition before, during and after gestation

    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

    Between recruitment and delivery

  • +39 more secondary outcomes

Other Outcomes (6)

  • Health economics analysis (cost benefit analysis)

    Composite analysis between preconception visit which is up to 1 year before pregnancy and infant age 3.5 years, assessed up to 5.5 years

  • Offspring neurocognitive and behavioural development (behavioural and Ages & Stages questionnaires)

    Up to 3.5 years, from birth to infant age 3.5 years

  • Offspring respiratory development (absence of respiratory symptoms)

    Up to 3.5 years, from birth to infant age 3.5 years

  • +3 more other outcomes

Study Arms (2)

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.

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.

Dietary Supplement: Standard nutritional drink

Interventions

Study nutritional drinkDIETARY_SUPPLEMENT

Study nutritional drink containing a mix of micronutrients, probiotics and myo-inositol.

Intervention (study nutritional drink)
Standard nutritional drinkDIETARY_SUPPLEMENT

Standard nutritional drink containing a mix of micronutrients.

Control (standard nutritional drink)

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The University of Auckland

Auckland, 1142, New Zealand

Location

National University Hospital

Singapore, 119074, Singapore

Location

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (10)

  • 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.

    PMID: 28320484BACKGROUND

  • 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.

    PMID: 38411017DERIVED

  • 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.

    PMID: 38287349DERIVED

  • 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.

    PMID: 38051700DERIVED

  • 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.

    PMID: 37915619DERIVED

  • 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.

    PMID: 36866469DERIVED

  • 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.

    PMID: 36754158DERIVED

  • 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.

    PMID: 36704795DERIVED

  • 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.

    PMID: 36628060DERIVED

  • 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.

    PMID: 33782086DERIVED

Related Links

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Wayne Cutfield, BHB MB ChB DCH MD FRACP

    The University of Auckland

    PRINCIPAL INVESTIGATOR

  • Shiao-Yng Chan, MBBChir (UK), FRCOG (UK), PhD

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

  • Keith Godfrey, BM PhD FRCP

    MRC Lifecourse Epidemiology Unit, University of Southampton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 28, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2018

Study Completion

June 1, 2022

Last Updated

May 15, 2023

Record last verified: 2023-05

Locations

GB(1)NZ(1)SG(1)