Obesity, ChildhoodNiPPeR ChildNCT05934422
NiPPeR Randomised Trial - Child Follow Up Study
A study testing Intervention (Study Nutritional Drink) in people with Obesity, Childhood and Cognition, run by University of Southampton at 3 sites in 3 countries.
Trial summary
There is an increasing focus on the need to optimise nutrition, lifestyle and metabolism of parents before and during pregnancy and of the infant after birth, but as yet there is limited understanding of the specific influences and of the underlying mechanisms. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Cognition, Neurobehavioral Manifestations
- What is being tested?
- Intervention (Study Nutritional Drink)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 16 Jun 2023to 14 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children still participating in the NiPPeR study at 6-8 years.
Who cannot join
- Known significant congenital anomaly or genetic condition that influences child growth or neurodevelopment.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
University Hospital Southampton
Southampton, Hampshire, SO16 6YD
About this study
Official title: Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health - Child Health and Well-being Follow Up Study
There is an increasing focus on the need to optimise nutrition, lifestyle and metabolism of parents before and during pregnancy and of the infant after birth, but as yet there is limited understanding of the specific influences and of the underlying mechanisms.
This study is a follow up of children from the NiPPeR trial of a nutritional drink enriched with micronutrients, myo-inositol and probiotics taken preconception and during pregnancy. In this setting we will examine the influence of parental nutrition, lifestyle and metabolism before and during pregnancy on child growth, development and well-being; ascertaining growth, adiposity, metabolism, neurobehavioural and health outcomes in the children, and characterising the underlying mechanisms.
The data collected will allow identification of the contributions of parental and offspring characteristics, nutritional, lifestyle and medical factors, social and economic status, ethnicity, genetics, metabolism and microbes to promoting healthy growth, body composition and wellbeing in the children.
- Conditions
- Obesity, Childhood, Cognition, Neurobehavioral Manifestations, Metabolic Disturbance, Growth Disorders, Allergy
- Being tested
- Intervention (Study Nutritional Drink), Control (Standard Nutritional Drink)
- Keywords
- Nutrition, Body composition, Neurodevelopment, Lifestyle, Endocrinology and metabolism, Preconception, Supplementation, Pregnancy, Infancy, Breast milk
- Medical subject headings
- Pediatric Obesity, Neurobehavioral Manifestations, Growth Disorders, Hypersensitivity, Dermatitis, Atopic, Communicable Diseases, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention (Study Nutritional Drink)Other
Study nutritional drink containing a mix of enriched micronutrients, probiotics and myo-inositol.
Control (Standard Nutritional Drink)Other
Control nutritional drink containing a standard mix of micronutrients
| Study group | Role | What they receive |
|---|---|---|
| Prior Intervention - enhanced micronutrients, probiotics, myo-inositol in preconception & pregnancy | Experimental | NiPPeR Study intervention drink containing a mix of micronutrients, probiotics and myo-inositol given to the mother during preconception \& pregnancy Receives: Other: Intervention (Study Nutritional Drink) |
| Prior Control - standard micronutrients in preconception & pregnancy | Active comparator | NiPPeR Study control nutritional drink containing a mix of micronutrients given to the mother during preconception \& pregnancy Receives: Other: Control (Standard Nutritional Drink) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Body Mass Index (kg/m2), derived from weight and height
Child size and body composition
Measured: Up to age 8 years, from periconception to age 8 years
Intellectual function (WASI-II IQ [4 sub-test scores], higher score is a higher IQ)
Child cognition
Measured: Up to age 8 years, from periconception to age 8 years
Child insulin resistance (HOMA2-IR [no units], higher value is greater insulin resistance)
Child insulin resistance
Measured: Up to age 8 years, from periconception to age 8 years
Dimensional Change Card Sort Test (raw & T-scores)
Child executive functioning - NIH Toolbox Cognition Battery component
Measured: Up to age 8 years, from periconception to age 8 years
Flanker Inhibitory Control & Attention Test (raw & T-scores)
Child executive functioning - NIH Toolbox Cognition Battery Component
Measured: Up to age 8 years, from periconception to age 8 years
Strengths & Difficulties Questionnaire score (no units)
Child neurobehavioural functioning
Measured: Up to age 8 years, from periconception to age 8 years
Child Behaviour Check List score (no units)
Child neurobehavioural functioning
Measured: Up to age 8 years, from periconception to age 8 years
Secondary outcomes (54)
Body fat mass (kg, % and indices)
Obesity and body composition
Measured: Up to age 8 years, from periconception to age 8 years
Change in body fat mass (kg)
Adiposity gain
Measured: Up to age 8 years, from periconception to age 8 years
Body lean mass (kg, % and indices)
Child body composition - lean mass
Measured: Up to age 8 years, from periconception to age 8 years
Change in lean mass (kg)
Lean mass gain
Measured: Up to age 8 years, from periconception to age 8 years
Body bone mass (kg, % and indices)
Child body composition - bone mass
Measured: Up to age 8 years, from periconception to age 8 years
Change in bone mass (kg)
Bone mass gain
Measured: Up to age 8 years, from periconception to age 8 years
Child height (cm)
Child height
Measured: Up to age 8 years, from periconception to age 8 years
Height growth (cm)
Linear growth
Measured: Up to age 8 years, from periconception to age 8 years
Change in body mass index (z-score & percentile)
Change in BMI
Measured: Up to age 8 years, from periconception to age 8 years
Change in weight (kg)
Weight gain
Measured: Up to age 8 years, from periconception to age 8 years
Child mid-upper arm circumference (cm)
Child arm circumference
Measured: Up to age 8 years, from periconception to age 8 years
Change in mid-upper circumference (z-score)
Change in soft tissue mass
Measured: Up to age 8 years, from periconception to age 8 years
Child waist circumference (cm)
Child waist circumference
Measured: Up to age 8 years, from periconception to age 8 years
Change in waist circumference (z-score)
Adiposity gain
Measured: Up to age 8 years, from periconception to age 8 years
Heart rate response to step test (beats per minute)
Cardiovascular fitness and function
Measured: Up to age 8 years, from periconception to age 8 years
Child blood pressure (mm Hg)
Cardiovascular fitness and function
Measured: Up to age 8 years, from periconception to age 8 years
Child resting heart rate (beats per minute)
Cardiovascular fitness and function
Measured: Up to age 8 years, from periconception to age 8 years
Child minutes to return to resting heart rate (minutes)
Cardiovascular fitness and function
Measured: Up to age 8 years, from periconception to age 8 years
Diagnosed medical conditions or disorders ascertained by questionnaire, including child medical conditions, infections, gastrointestinal, cardiovascular, respiratory, dermatological, neuropsychological, mental and musculoskeletal health and wellbeing
Child health and wellbeing
Measured: Up to age 8 years, from periconception to age 8 years
Dietary patterns ascertained by frequency questionnaires
Child diet
Measured: Up to age 8 years, from periconception to age 8 years
Child Eating Behaviour Questionnaire
Child eating behaviours
Measured: Up to age 8 years, from periconception to age 8 years
Parental Feeding Practices Questionnaire
Parental feeding practices
Measured: Up to age 8 years, from periconception to age 8 years
Children's Sleep Habits Questionnaire
Child sleep patterns
Measured: Up to age 8 years, from periconception to age 8 years
Children's actigraphy measurements of activity behaviours [minutes/day]
Child physical activity, sleep and sedentary behaviours
Measured: Up to age 8 years, from periconception to age 8 years
Child Movement Behaviour Questionnaire
Child activity behaviours
Measured: Up to age 8 years, from periconception to age 8 years
Skin pricks test results to allergens [mm]
Child atopic sensitisation
Measured: Up to age 8 years, from periconception to age 8 years
Child asthma, wheezing illnesses, eczema, rhinitis and food allergy by clinical examination & questionnaires
Child atopic and allergic wellbeing and disorders
Measured: Up to age 8 years, from periconception to age 8 years
Hair metabolome panel concentrations (pmol/L)
Biomarkers of health and wellbeing measured in hair samples
Measured: Up to age 8 years, from periconception to age 8 years
Urine micronutrient concentrations (nmol/L)
Child micronutrient status
Measured: Up to age 8 years, from periconception to age 8 years
Blood micronutrient concentrations (nmol/L)
Child circulating micronutrient profile
Measured: Up to age 8 years, from periconception to age 8 years
Blood trace element concentrations (pmol/L)
Child circulating trace element profile
Measured: Up to age 8 years, from periconception to age 8 years
Urine trace element concentrations (pmol/L)
Child trace element status
Measured: Up to age 8 years, from periconception to age 8 years
Stool metagenomic profile (abundance)
Child gut microbiota composition
Measured: Up to age 8 years, from periconception to age 8 years
Skin metagenomic profile (abundance)
Child skin microbiota composition
Measured: Up to age 8 years, from periconception to age 8 years
Stool metatranscriptomic profile (relative activity)
Child gut microbiota activity profile
Measured: Up to age 8 years, from periconception to age 8 years
Skin metatranscriptomic profile (relative activity)
Child skin microbiota activity profile
Measured: Up to age 8 years, from periconception to age 8 years
Stool metabolomic profile (pmol/L)
Child gut microbiota metabolite profile
Measured: Up to age 8 years, from periconception to age 8 years
Skin metabolomic profile (pmol/L)
Child skin microbiota metabolite profile
Measured: Up to age 8 years, from periconception to age 8 years
Blood molecular profile (% methylation)
Child blood epigenetic profile
Measured: Up to age 8 years, from periconception to age 8 years
Buccal molecular profile (% methylation)
Child buccal cell epigenetic profile
Measured: Up to age 8 years, from periconception to age 8 years
Blood transcriptomic profile (relative expression)
Child blood transcriptomic profile
Measured: Up to age 8 years, from periconception to age 8 years
Buccal transcriptomic profile (relative expression)
Child buccal cell transcriptomic profile
Measured: Up to age 8 years, from periconception to age 8 years
Genetic variation (DNA sequence analysis)
Genetic variant analysis
Measured: Up to age 8 years, from periconception to age 8 years
Circulating chemocytokine measurements (nmol/L)
Child chemocytokine profile
Measured: Up to age 8 years, from periconception to age 8 years
Circulating adipokine measurements (nmol/L)
Child adipokine profile
Measured: Up to age 8 years, from periconception to age 8 years
Circulating inflammatory marker measurement (nmol/L)
Child inflammatory factor profile
Measured: Up to age 8 years, from periconception to age 8 years
Plasma glucose concentration (mmol/L)
Child's plasma glycemia
Measured: Up to age 8 years, from periconception to age 8 years
Plasma lipid concentrations (mmol/L)
Child's metabolic profile - lipid concentrations
Measured: Up to age 8 years, from periconception to age 8 years
Plasma high-sensitivity C-reactive protein concentrations (mmol/L)
Child's inflammatory marker status
Measured: Up to age 8 years, from periconception to age 8 years
Blood metabolome panel concentrations (pmol/L)
Child's blood metabolomic status
Measured: Up to age 8 years, from periconception to age 8 years
Urine metabolome panel concentrations (pmol/L)
Child's urine metabolomic status
Measured: Up to age 8 years, from periconception to age 8 years
Urine measurement of environmental pollutant exposure (pmol/L)
Urine exposome pollutant profile
Measured: Up to age 8 years, from periconception to age 8 years
Blood measurement of environmental pollutant exposure (ng/gm lipid)
Blood exposome pollutant profile
Measured: Up to age 8 years, from periconception to age 8 years
Hair measurement of environmental pollutant exposure (pmol/L)
Hair exposome pollutant profile
Measured: Up to age 8 years, from periconception to age 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start16 Jun 2023
- Primary completion14 Aug 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- National University Hospital, Singapore, Auckland UniServices Ltd., Institute for Human Development and Potential (IHDP), Singapore, National University of Singapore, National University Health System, Singapore, University of Auckland, New Zealand
- Responsible party
- Sponsor
- Investigators
- Wayne S Cutfield, MB MD FRACP, Principal investigator, The University of AucklandShiao-Yng Chan, MD PhD FRCOG, Principal investigator, National University of SingaporeKeith M Godfrey, BM PhD FRCP, Principal investigator, MRC Lifecourse Epidemiology Centre, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934422
- Sponsor's protocol ID
- 79093
- Acronym
- NiPPeR Child
- Status last verified
- Dec 2024
- First submitted
- 4 May 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28320484Godfrey 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.
PubMed 33782086
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health - Child Health and Well-being Follow Up Study
- ClinicalTrials.gov ID
- NCT05934422
- Acronym / sponsor ID
- NiPPeR Child / 79093
- Conditions
- Obesity, Childhood, Cognition, Neurobehavioral Manifestations, Metabolic Disturbance, Growth Disorders, Allergy
- Keywords
- Nutrition, Body composition, Neurodevelopment, Lifestyle, Endocrinology and metabolism, Preconception, Supplementation, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- National University Hospital, Singapore, Auckland UniServices Ltd., Institute for Human Development and Potential (IHDP), Singapore, National University of Singapore, National University Health System, Singapore, University of Auckland, New Zealand
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is an increasing focus on the need to optimise nutrition, lifestyle and metabolism of parents before and during pregnancy and of the infant after birth, but as yet there is limited understanding of the specific influences and of the underlying mechanisms.
This study is a follow up of children from the NiPPeR trial of a nutritional drink enriched with micronutrients, myo-inositol and probiotics taken preconception and during pregnancy. In this setting we will examine the influence of parental nutrition, lifestyle and metabolism before and during pregnancy on child growth, development and well-being; ascertaining growth, adiposity, metabolism, neurobehavioural and health outcomes in the children, and characterising the underlying mechanisms.
The data collected will allow identification of the contributions of parental and offspring characteristics, nutritional, lifestyle and medical factors, social and economic status, ethnicity, genetics, metabolism and microbes to promoting healthy growth, body composition and wellbeing in the children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prior Intervention - enhanced micronutrients, probiotics, myo-inositol in preconception & pregnancy | Experimental | Other: Intervention (Study Nutritional Drink)NiPPeR Study intervention drink containing a mix of micronutrients, probiotics and myo-inositol given to the mother during preconception \& pregnancy |
| Prior Control - standard micronutrients in preconception & pregnancy | Active comparator | Other: Control (Standard Nutritional Drink)NiPPeR Study control nutritional drink containing a mix of micronutrients given to the mother during preconception \& pregnancy |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children still participating in the NiPPeR study at 6-8 years.
Key exclusion criteria (1 listed)
- Known significant congenital anomaly or genetic condition that influences child growth or neurodevelopment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention (Study Nutritional Drink)Study nutritional drink containing a mix of enriched micronutrients, probiotics and myo-inositol. | Other | Prior Intervention - enhanced micronutrients, probiotics, myo-inositol in preconception & pregnancy |
| Control (Standard Nutritional Drink)Control nutritional drink containing a standard mix of micronutrients | Other | Prior Control - standard micronutrients in preconception & pregnancy |
Primary outcome
Child Body Mass Index (kg/m2), derived from weight and height
Time frame: Up to age 8 years, from periconception to age 8 years
Child size and body composition
Intellectual function (WASI-II IQ [4 sub-test scores], higher score is a higher IQ)
Time frame: Up to age 8 years, from periconception to age 8 years
Child cognition
Child insulin resistance (HOMA2-IR [no units], higher value is greater insulin resistance)
Time frame: Up to age 8 years, from periconception to age 8 years
Child insulin resistance
Dimensional Change Card Sort Test (raw & T-scores)
Time frame: Up to age 8 years, from periconception to age 8 years
Child executive functioning - NIH Toolbox Cognition Battery component
Flanker Inhibitory Control & Attention Test (raw & T-scores)
Time frame: Up to age 8 years, from periconception to age 8 years
Child executive functioning - NIH Toolbox Cognition Battery Component
Strengths & Difficulties Questionnaire score (no units)
Time frame: Up to age 8 years, from periconception to age 8 years
Child neurobehavioural functioning
Child Behaviour Check List score (no units)
Time frame: Up to age 8 years, from periconception to age 8 years
Child neurobehavioural functioning
54 secondary outcomes
Body fat mass (kg, % and indices)
Time frame: Up to age 8 years, from periconception to age 8 years
Change in body fat mass (kg)
Time frame: Up to age 8 years, from periconception to age 8 years
Body lean mass (kg, % and indices)
Time frame: Up to age 8 years, from periconception to age 8 years
Change in lean mass (kg)
Time frame: Up to age 8 years, from periconception to age 8 years
Body bone mass (kg, % and indices)
Time frame: Up to age 8 years, from periconception to age 8 years
Change in bone mass (kg)
Time frame: Up to age 8 years, from periconception to age 8 years
Child height (cm)
Time frame: Up to age 8 years, from periconception to age 8 years
Height growth (cm)
Time frame: Up to age 8 years, from periconception to age 8 years
Change in body mass index (z-score & percentile)
Time frame: Up to age 8 years, from periconception to age 8 years
Change in weight (kg)
Time frame: Up to age 8 years, from periconception to age 8 years
Child mid-upper arm circumference (cm)
Time frame: Up to age 8 years, from periconception to age 8 years
Change in mid-upper circumference (z-score)
Time frame: Up to age 8 years, from periconception to age 8 years
Child waist circumference (cm)
Time frame: Up to age 8 years, from periconception to age 8 years
Change in waist circumference (z-score)
Time frame: Up to age 8 years, from periconception to age 8 years
Heart rate response to step test (beats per minute)
Time frame: Up to age 8 years, from periconception to age 8 years
Child blood pressure (mm Hg)
Time frame: Up to age 8 years, from periconception to age 8 years
Child resting heart rate (beats per minute)
Time frame: Up to age 8 years, from periconception to age 8 years
Child minutes to return to resting heart rate (minutes)
Time frame: Up to age 8 years, from periconception to age 8 years
Diagnosed medical conditions or disorders ascertained by questionnaire, including child medical conditions, infections, gastrointestinal, cardiovascular, respiratory, dermatological, neuropsychological, mental and musculoskeletal health and wellbeing
Time frame: Up to age 8 years, from periconception to age 8 years
Dietary patterns ascertained by frequency questionnaires
Time frame: Up to age 8 years, from periconception to age 8 years
Child Eating Behaviour Questionnaire
Time frame: Up to age 8 years, from periconception to age 8 years
Parental Feeding Practices Questionnaire
Time frame: Up to age 8 years, from periconception to age 8 years
Children's Sleep Habits Questionnaire
Time frame: Up to age 8 years, from periconception to age 8 years
Children's actigraphy measurements of activity behaviours [minutes/day]
Time frame: Up to age 8 years, from periconception to age 8 years
Child Movement Behaviour Questionnaire
Time frame: Up to age 8 years, from periconception to age 8 years
Skin pricks test results to allergens [mm]
Time frame: Up to age 8 years, from periconception to age 8 years
Child asthma, wheezing illnesses, eczema, rhinitis and food allergy by clinical examination & questionnaires
Time frame: Up to age 8 years, from periconception to age 8 years
Hair metabolome panel concentrations (pmol/L)
Time frame: Up to age 8 years, from periconception to age 8 years
Urine micronutrient concentrations (nmol/L)
Time frame: Up to age 8 years, from periconception to age 8 years
Blood micronutrient concentrations (nmol/L)
Time frame: Up to age 8 years, from periconception to age 8 years
Blood trace element concentrations (pmol/L)
Time frame: Up to age 8 years, from periconception to age 8 years
Urine trace element concentrations (pmol/L)
Time frame: Up to age 8 years, from periconception to age 8 years
Stool metagenomic profile (abundance)
Time frame: Up to age 8 years, from periconception to age 8 years
Skin metagenomic profile (abundance)
Time frame: Up to age 8 years, from periconception to age 8 years
Stool metatranscriptomic profile (relative activity)
Time frame: Up to age 8 years, from periconception to age 8 years
Skin metatranscriptomic profile (relative activity)
Time frame: Up to age 8 years, from periconception to age 8 years
Stool metabolomic profile (pmol/L)
Time frame: Up to age 8 years, from periconception to age 8 years
Skin metabolomic profile (pmol/L)
Time frame: Up to age 8 years, from periconception to age 8 years
Blood molecular profile (% methylation)
Time frame: Up to age 8 years, from periconception to age 8 years
Buccal molecular profile (% methylation)
Time frame: Up to age 8 years, from periconception to age 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Background: PubMed 28320484Godfrey 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.
- Background: PubMed 33782086Godfrey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne S Cutfield, MB MD FRACP principal investigator
The University of Auckland
Shiao-Yng Chan, MD PhD FRCOG principal investigator
National University of Singapore
Keith M Godfrey, BM PhD FRCP principal investigator
MRC Lifecourse Epidemiology Centre, University of Southampton
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention (Study Nutritional Drink) in people with Obesity, Childhood and Cognition, run by University of Southampton at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in New Zealand, Singapore, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Body Mass Index (kg/m2), derived from weight and height (time frame: Up to age 8 years, from periconception to age 8 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05934422, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025; AzTrials last refreshed its copy on 27 Oct 2026.