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Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health (NiPPeR)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02509988
First Posted: July 28, 2015
Last Update Posted: May 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National University Hospital, Singapore
Auckland UniServices Ltd.
Singapore Institute for Clinical Sciences
National University, Singapore
Nestec Ltd.
Information provided by (Responsible Party):
University of Southampton
  Purpose
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.

Condition Intervention
Hyperglycemia Dietary Supplement: Study nutritional drink Dietary Supplement: Standard nutritional drink

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health "(NiPPeR)"

Resource links provided by NLM:


Further study details as provided by University of Southampton:

Primary Outcome Measures:
  • Glucose tolerance during pregnancy [ Time Frame: Pregnancy Oral Glucose Tolerance Test (OGTT) measurement at 28 weeks gestation ]

Secondary Outcome Measures:
  • Duration of gestation [ Time Frame: Up to 43 weeks, between date of last menstrual period and date of delivery ]
  • Pregnancy weight gain [ Time Frame: Up to 95 weeks, between date of preconception visit and date of delivery ]
  • Gestational diabetes frequency [ Time Frame: Pregnancy OGTT measurement at 28 weeks gestation ]
  • Nausea and vomiting frequency [ Time Frame: Up to 12 weeks, between 7 and 19 weeks gestation ]
  • Antenatal maternal wellbeing/mood (Edinburgh Post-natal Depression Scale and State-Trait Anxiety Inventory) [ Time Frame: Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation ]
  • 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 delivery [ Time Frame: 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 profile (analysis of sequencing 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 maternal gut microbiota composition profile (analysis of sequencing data) [ Time Frame: Up to 36 weeks, between 7 weeks gestation and date of delivery ]
  • Maternal preconception metabolomic profile [ 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 metabolomic profile [ Time Frame: Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation ]
  • Maternal postnatal metabolomic profile [ Time Frame: 6 months after delivery ]
  • Maternal preconception epigenetic profile [ Time Frame: Second preconception visit 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 3 months, between date of delivery and 3 months postpartum ]
  • Breast milk micronutrient profile (subsample) [ Time Frame: Up to 3 months, between date of delivery and 3 months postpartum ]
  • Breast milk immune factor profile (subsample) [ Time Frame: Up to 3 months, between date of delivery and 3 months postpartum ]
  • Breast milk epigenetic profile (subsample) [ Time Frame: Up to 3 months, between date of delivery and 3 months postpartum ]
  • Breast milk metabolomic profile (subsample) [ Time Frame: Up to 3 months, between date of delivery and 3 months postpartum ]
  • Healthy lactogenesis (onset of lactation) [ Time Frame: Up to 3 months, between date of delivery and 3 months postpartum ]
  • Offspring birthweight 2,500-4,000 g [ Time Frame: At birth ]
  • Offspring size for gestational age size at birth (birthweight 10th-90th percentile for gestational age) [ Time Frame: At birth ]
  • Offspring size for gestational age size at birth (customised birthweight centile 10th-90th centile) [ Time Frame: At birth ]
  • Offspring adiposity (skinfold thicknesses, total and percentage fat mass) [ Time Frame: Up to 6 weeks, from date of birth to 6 weeks ]
  • Adiposity gain during infancy [ Time Frame: Up to 52 weeks, from birth to infant age 12 months ]
  • Cord blood C-peptide [ Time Frame: At delivery ]
  • Offspring healthy cardiometabolic risk factor profile [ Time Frame: Up to 52 weeks, from birth to infant age 12 months ]
  • Offspring allergic wellbeing (absence of allergic symptoms) [ Time Frame: Up to 52 weeks, from birth to infant age 12 months ]
  • Offspring metabolomic profile related to metabolic health [ Time Frame: Up to 52 weeks, from birth to infant age 12 months ]
  • Offspring metabolomic profile related to allergy [ Time Frame: Up to 52 weeks, from birth to infant age 12 months ]
  • Offspring epigenetic profile related to metabolic health [ Time Frame: Up to 52 weeks, from birth to infant age 12 months ]
  • Offspring epigenetic profile related to allergy [ Time Frame: Up to 52 weeks, from birth to infant age 12 months ]
  • Infant gut microbiota composition [ Time Frame: Up to 52 weeks, from birth to infant age 12 months ]

Other Outcome Measures:
  • Health economics analysis (Quality ‐ Adjusted Life Years) [ Time Frame: Composite analysis between preconception visit which is up to 1 year before pregnancy and infant age 12 months, assessed up to 34 months ]
  • Offspring neurocognitive development (relational binding analysis) [ Time Frame: Up to 52 weeks, from birth to infant age 12 months ]
  • Offspring respiratory development (absence of respiratory symptoms) [ Time Frame: Up to 52 weeks, from birth to infant age 12 months ]
  • Offspring allergic development (skin prick test reaction diameter) [ Time Frame: Up to 52 weeks, from birth to infant age 12 months ]

Enrollment: 1731
Actual Study Start Date: July 2015
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Dietary Supplement: Standard nutritional drink
Standard nutritional drink containing a mix of micronutrients.

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 1800 women, aged 18-38 years, who are planning a pregnancy in the United Kingdom, Singapore and New Zealand. 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 the first year 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.

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 and promoting healthy growth, body composition and wellbeing in the children.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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 12 months.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509988


Locations
New Zealand
The University of Auckland
Auckland, New Zealand, 1142
Singapore
National University Hospital
Singapore, Singapore, 119074
United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
Sponsors and Collaborators
University of Southampton
National University Hospital, Singapore
Auckland UniServices Ltd.
Singapore Institute for Clinical Sciences
National University, Singapore
Nestec Ltd.
Investigators
Principal Investigator: Wayne Cutfield, BHB MB ChB DCH MD FRACP The University of Auckland
Principal Investigator: Yap Seng Chong, MBBS MRCOG MMED MD FAMS National University Hospital, Singapore
Principal Investigator: Keith Godfrey, BM PhD FRCP MRC Lifecourse Epidemiology Unit, University of Southampton
  More Information

Additional Information:
Responsible Party: University of Southampton
ClinicalTrials.gov Identifier: NCT02509988     History of Changes
Other Study ID Numbers: 13597
34104 ( Other Identifier: Auckland UniServices Ltd. )
2015/00205 ( Other Identifier: National University Hospital Singapore )
U1111-1171-8056 ( Other Identifier: Universal Trial Number )
First Submitted: July 16, 2015
First Posted: July 28, 2015
Last Update Posted: May 16, 2017
Last Verified: May 2017

Keywords provided by University of Southampton:
Nutrition
Glucose metabolism
Body composition

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases