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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05934422
Other study ID # 79093
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 16, 2023
Est. completion date August 30, 2026

Study information

Verified date June 2023
Source University of Southampton
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 510
Est. completion date August 30, 2026
Est. primary completion date August 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 8 Years
Eligibility Inclusion Criteria: All children still participating in the NiPPeR study at 6-8 years. Exclusion Criteria: Known significant congenital anomaly or genetic condition that influences child growth or neurodevelopment.

Study Design


Intervention

Other:
Intervention (Study Nutritional Drink)
Study nutritional drink containing a mix of enriched micronutrients, probiotics and myo-inositol.
Control (Standard Nutritional Drink)
Control nutritional drink containing a standard mix of micronutrients

Locations

Country Name City State
New Zealand The University of Auckland Auckland
Singapore National University Hospital Singapore
United Kingdom University Hospital Southampton Southampton Hampshire

Sponsors (7)

Lead Sponsor Collaborator
University of Southampton Auckland UniServices Ltd., National University Health System, Singapore, National University Hospital, Singapore, National University of Singapore, Singapore Institute for Clinical Sciences, University of Auckland, New Zealand

Countries where clinical trial is conducted

New Zealand,  Singapore,  United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Healthcare utilisation (US$) Health economics analysis of child outcomes Up to age 8 years, from periconception to age 8 years
Primary Child Body Mass Index (kg/m2), derived from weight and height Child size and body composition Up to age 8 years, from periconception to age 8 years
Primary Intellectual function (WASI-II IQ [4 sub-test scores], higher score is a higher IQ) Child cognition Up to age 8 years, from periconception to age 8 years
Primary Child insulin resistance (HOMA2-IR [no units], higher value is greater insulin resistance) Child insulin resistance Up to age 8 years, from periconception to age 8 years
Primary Dimensional Change Card Sort Test (raw & T-scores) Child executive functioning - NIH Toolbox Cognition Battery component Up to age 8 years, from periconception to age 8 years
Primary Flanker Inhibitory Control & Attention Test (raw & T-scores) Child executive functioning - NIH Toolbox Cognition Battery Component Up to age 8 years, from periconception to age 8 years
Primary Strengths & Difficulties Questionnaire score (no units) Child neurobehavioural functioning Up to age 8 years, from periconception to age 8 years
Primary Child Behaviour Check List score (no units) Child neurobehavioural functioning Up to age 8 years, from periconception to age 8 years
Secondary Body fat mass (kg, % and indices) Obesity and body composition Up to age 8 years, from periconception to age 8 years
Secondary Change in body fat mass (kg) Adiposity gain Up to age 8 years, from periconception to age 8 years
Secondary Body lean mass (kg, % and indices) Child body composition - lean mass Up to age 8 years, from periconception to age 8 years
Secondary Change in lean mass (kg) Lean mass gain Up to age 8 years, from periconception to age 8 years
Secondary Body bone mass (kg, % and indices) Child body composition - bone mass Up to age 8 years, from periconception to age 8 years
Secondary Change in bone mass (kg) Bone mass gain Up to age 8 years, from periconception to age 8 years
Secondary Child height (cm) Child height Up to age 8 years, from periconception to age 8 years
Secondary Height growth (cm) Linear growth Up to age 8 years, from periconception to age 8 years
Secondary Change in body mass index (z-score & percentile) Change in BMI Up to age 8 years, from periconception to age 8 years
Secondary Change in weight (kg) Weight gain Up to age 8 years, from periconception to age 8 years
Secondary Child mid-upper arm circumference (cm) Child arm circumference Up to age 8 years, from periconception to age 8 years
Secondary Change in mid-upper circumference (z-score) Change in soft tissue mass Up to age 8 years, from periconception to age 8 years
Secondary Child waist circumference (cm) Child waist circumference Up to age 8 years, from periconception to age 8 years
Secondary Change in waist circumference (z-score) Adiposity gain Up to age 8 years, from periconception to age 8 years
Secondary Heart rate response to step test (beats per minute) Cardiovascular fitness and function Up to age 8 years, from periconception to age 8 years
Secondary Child blood pressure (mm Hg) Cardiovascular fitness and function Up to age 8 years, from periconception to age 8 years
Secondary Child resting heart rate (beats per minute) Cardiovascular fitness and function Up to age 8 years, from periconception to age 8 years
Secondary Child minutes to return to resting heart rate (minutes) Cardiovascular fitness and function Up to age 8 years, from periconception to age 8 years
Secondary 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 Up to age 8 years, from periconception to age 8 years
Secondary Dietary patterns ascertained by frequency questionnaires Child diet Up to age 8 years, from periconception to age 8 years
Secondary Child Eating Behaviour Questionnaire Child eating behaviours Up to age 8 years, from periconception to age 8 years
Secondary Parental Feeding Practices Questionnaire Parental feeding practices Up to age 8 years, from periconception to age 8 years
Secondary Children's Sleep Habits Questionnaire Child sleep patterns Up to age 8 years, from periconception to age 8 years
Secondary Children's actigraphy measurements of activity behaviours [minutes/day] Child physical activity, sleep and sedentary behaviours Up to age 8 years, from periconception to age 8 years
Secondary Child Movement Behaviour Questionnaire Child activity behaviours Up to age 8 years, from periconception to age 8 years
Secondary Skin pricks test results to allergens [mm] Child atopic sensitisation Up to age 8 years, from periconception to age 8 years
Secondary Child asthma, wheezing illnesses, eczema, rhinitis and food allergy by clinical examination & questionnaires Child atopic and allergic wellbeing and disorders Up to age 8 years, from periconception to age 8 years
Secondary Hair metabolome panel concentrations (pmol/L) Biomarkers of health and wellbeing measured in hair samples Up to age 8 years, from periconception to age 8 years
Secondary Urine micronutrient concentrations (nmol/L) Child micronutrient status Up to age 8 years, from periconception to age 8 years
Secondary Blood micronutrient concentrations (nmol/L) Child circulating micronutrient profile Up to age 8 years, from periconception to age 8 years
Secondary Blood trace element concentrations (pmol/L) Child circulating trace element profile Up to age 8 years, from periconception to age 8 years
Secondary Urine trace element concentrations (pmol/L) Child trace element status Up to age 8 years, from periconception to age 8 years
Secondary Stool metagenomic profile (abundance) Child gut microbiota composition Up to age 8 years, from periconception to age 8 years
Secondary Skin metagenomic profile (abundance) Child skin microbiota composition Up to age 8 years, from periconception to age 8 years
Secondary Stool metatranscriptomic profile (relative activity) Child gut microbiota activity profile Up to age 8 years, from periconception to age 8 years
Secondary Skin metatranscriptomic profile (relative activity) Child skin microbiota activity profile Up to age 8 years, from periconception to age 8 years
Secondary Stool metabolomic profile (pmol/L) Child gut microbiota metabolite profile Up to age 8 years, from periconception to age 8 years
Secondary Skin metabolomic profile (pmol/L) Child skin microbiota metabolite profile Up to age 8 years, from periconception to age 8 years
Secondary Blood molecular profile (% methylation) Child blood epigenetic profile Up to age 8 years, from periconception to age 8 years
Secondary Buccal molecular profile (% methylation) Child buccal cell epigenetic profile Up to age 8 years, from periconception to age 8 years
Secondary Blood transcriptomic profile (relative expression) Child blood transcriptomic profile Up to age 8 years, from periconception to age 8 years
Secondary Buccal transcriptomic profile (relative expression) Child buccal cell transcriptomic profile Up to age 8 years, from periconception to age 8 years
Secondary Genetic variation (DNA sequence analysis) Genetic variant analysis Up to age 8 years, from periconception to age 8 years
Secondary Circulating chemocytokine measurements (nmol/L) Child chemocytokine profile Up to age 8 years, from periconception to age 8 years
Secondary Circulating adipokine measurements (nmol/L) Child adipokine profile Up to age 8 years, from periconception to age 8 years
Secondary Circulating inflammatory marker measurement (nmol/L) Child inflammatory factor profile Up to age 8 years, from periconception to age 8 years
Secondary Plasma glucose concentration (mmol/L) Child's plasma glycemia Up to age 8 years, from periconception to age 8 years
Secondary Plasma lipid concentrations (mmol/L) Child's metabolic profile - lipid concentrations Up to age 8 years, from periconception to age 8 years
Secondary Plasma high-sensitivity C-reactive protein concentrations (mmol/L) Child's inflammatory marker status Up to age 8 years, from periconception to age 8 years
Secondary Blood metabolome panel concentrations (pmol/L) Child's blood metabolomic status Up to age 8 years, from periconception to age 8 years
Secondary Urine metabolome panel concentrations (pmol/L) Child's urine metabolomic status Up to age 8 years, from periconception to age 8 years
Secondary Urine measurement of environmental pollutant exposure (pmol/L) Urine exposome pollutant profile Up to age 8 years, from periconception to age 8 years
Secondary Blood measurement of environmental pollutant exposure (ng/gm lipid) Blood exposome pollutant profile Up to age 8 years, from periconception to age 8 years
Secondary Hair measurement of environmental pollutant exposure (pmol/L) Hair exposome pollutant profile Up to age 8 years, from periconception to age 8 years
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