Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Infant Neurodevelopment, Nutrition, Methylation, Birth Outcomes. Basic parameters: 0 Days — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Maternal Methyl-Nutrient Status During Pregnancy and Its Association With Infant Neurodevelopment: Exploring Potential Mechanisms
Overview
This prospective cohort study examines the relationship between maternal methyl-nutrient status during pregnancy and offspring neurodevelopment. It integrates maternal dietary, biomarker, genetic, and microbiome data and follows children up to 24 months.
Detailed description
Evidence regarding the association between maternal methyl-nutrient status during pregnancy and offspring neurodevelopment remains inconsistent. To address this gap, the present study is designed to comprehensively evaluate maternal methyl-nutrient status-specifically dietary intake and concentrations of choline, folate, betaine, and vitamin B12-at different gestational stages, and to examine their associations with infant and early childhood neurodevelopmental outcomes. This prospective mother-child cohort will recruit pregnant women aged 20-45 years from the Department of Obstetrics and Gynecology at Far Eastern Memorial Hospital who are receiving routine prenatal care and intend to deliver at the study site. At each trimester, maternal dietary intake will be assessed using a semi-quantitative food frequency questionnaire and three-day dietary records, accompanied by the collection of blood and stool specimens. These samples will be analyzed for metabolic biomarkers (e.g., homocysteine, trimethylamine N-oxide \[TMAO\], and gut microbiota composition). Furthermore, genetic polymorphisms in one-carbon metabolism-related genes (e.g., MTHFR, PEMT), maternal DNA methylation status, and the expression of neurodevelopment-related genes will be measured to investigate potential mechanistic pathways. Infant outcomes will include neonatal anthropometrics (gestational age, birth weight, length, and head circumference) and longitudinal neurodevelopmental assessments at 6 months, 12 months, and 24 months using the Bayley Scales of Infant and Toddler Development. In addition, meconium and cord blood samples at birth and stool samples during infancy will be collected for analysis. By integrating multi-dimensional data on maternal nutrition, genetics, metabolism, and the gut microbiome, this study seeks to construct a comprehensive model linking maternal methyl-nutrient status during pregnancy with offspring neurodevelopment. The findings are expected to inform evidence-based recommendations for optimal methyl-nutrient intake during pregnancy in Taiwan, thereby contributing to prenatal nutrition guidelines and early preventive strategies against developmental delays.
Primary outcome measures
- Ｍaternal methyl-nutrient and other nutrition status [Time frame: From enrollment to delivery (approximately 9 months)]
- Birth anthropometric measurements of the newborn [Time frame: At birth]
- Infant neurodevelopmental outcomes [Time frame: At 6, 12, and 24 months of age]
Secondary outcome measures (6)
- Plasma homocysteine concentration [Time frame: During pregnancy (each trimester) and at birth (cord blood)]
- Plasma trimethylamine N-oxide (TMAO) concentration [Time frame: During pregnancy (each trimester) and at birth (cord blood)]
- Global DNA methylation levels [Time frame: During pregnancy (each trimester) and at birth (cord blood)]
- Gut microbiota composition [Time frame: During pregnancy (each trimester), at birth (meconium), and at 4, 6, 12, and 24 months of age]
- Genetic polymorphisms related to methyl metabolism [Time frame: During pregnancy]
- Expression levels of neurodevelopment-related genes [Time frame: During pregnancy (each trimester) and at birth (cord blood)]
Eligibility criteria
Inclusion Criteria for Pregnant Women
- Aged 20-45 years
- Singleton pregnancy
- Receiving routine prenatal care at the study site and planning to deliver at Far Eastern Memorial Hospital
Exclusion Criteria for Pregnant Women
- Diagnosed with major chronic diseases, including renal disease (defined as chronic kidney disease stage 3 or above or history of renal transplantation), liver disease (defined as liver cirrhosis or history of liver transplantation), or malignancy
- Alcohol consumption during pregnancy
- Diagnosed with eating disorders or psychiatric conditions that may impair the assessment of nutritional status
Inclusion Criteria for Newborns
● Newborns delivered by mothers who participate in this study
Exclusion Criteria for Newborns
- Diagnosed with congenital anomalies, epilepsy, or severe brain injury
- Inability to complete neurodevelopmental assessments at 6 months, 1 year, and 2 years of age at the study site
- Infants whose mothers are diagnosed with eating disorders or psychiatric conditions that may impair the assessment of nutritional status
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Taiwan · 2 centers
- Far Eastern Memorial Hospital — New Taipei City
- Far Eastern Memorial Hospital — New Taipei City
Identifiers
NCT: NCT07568561 · 114224-F