Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study
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- Состояния в реестре: Infant Neurodevelopment, Nutrition, Methylation, Birth Outcomes. Базовые параметры: 0 Days — 45 лет · Все.
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Официальное название
Maternal Methyl-Nutrient Status During Pregnancy and Its Association With Infant Neurodevelopment: Exploring Potential Mechanisms
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Ｍaternal methyl-nutrient and other nutrition status [Срок оценки: From enrollment to delivery (approximately 9 months)]
- Birth anthropometric measurements of the newborn [Срок оценки: At birth]
- Infant neurodevelopmental outcomes [Срок оценки: At 6, 12, and 24 months of age]
Вторичные конечные точки (6)
- Plasma homocysteine concentration [Срок оценки: During pregnancy (each trimester) and at birth (cord blood)]
- Plasma trimethylamine N-oxide (TMAO) concentration [Срок оценки: During pregnancy (each trimester) and at birth (cord blood)]
- Global DNA methylation levels [Срок оценки: During pregnancy (each trimester) and at birth (cord blood)]
- Gut microbiota composition [Срок оценки: During pregnancy (each trimester), at birth (meconium), and at 4, 6, 12, and 24 months of age]
- Genetic polymorphisms related to methyl metabolism [Срок оценки: During pregnancy]
- Expression levels of neurodevelopment-related genes [Срок оценки: During pregnancy (each trimester) and at birth (cord blood)]
Критерии участия
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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Тайвань · 2 центра
- Far Eastern Memorial Hospital — New Taipei City
- Far Eastern Memorial Hospital — New Taipei City
Идентификаторы
NCT: NCT07568561 · 114224-F