Maternal Methyl-Nutrient Status During Pregnancy and Its Association With Infant Neurodevelopment: Exploring Potential Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Ｍaternal methyl-nutrient and other nutrition status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
FEMHPregnancy cohort
Throughout pregnancy, delivery, and infant follow-up at FEMH
结局指标
主要结局
Ｍaternal methyl-nutrient and other nutrition status
时间窗: From enrollment to delivery (approximately 9 months)
Maternal methyl-nutrient status will be assessed using the following measurements: * Blood biomarkers: plasma or serum concentrations of choline(µmol/L), betaine(µmol/L), RBC and serum folate(ng/mL), vitamin B12 (pg/mL) measured using by standard laboratory assays * Dietary intake: assessed using a validated Food Frequency Questionnaire (FFQ) and 3-day dietary records
Birth anthropometric measurements of the newborn
时间窗: At birth
This outcome will be assessed using medical records, including birth weight (grams), birth length (centimeters) , birth head circumference (centimeters), and gestational age at birth (weeks).
Infant neurodevelopmental outcomes
时间窗: At 6, 12, and 24 months of age
Infant neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-IV), including composite scores for cognitive, language, motor and social-emotional domains
次要结局
- Plasma homocysteine concentration(During pregnancy (each trimester) and at birth (cord blood))
- Plasma trimethylamine N-oxide (TMAO) concentration(During pregnancy (each trimester) and at birth (cord blood))
- Global DNA methylation levels(During pregnancy (each trimester) and at birth (cord blood))
- Gut microbiota composition(During pregnancy (each trimester), at birth (meconium), and at 4, 6, 12, and 24 months of age)
- Genetic polymorphisms related to methyl metabolism(During pregnancy)
- Expression levels of neurodevelopment-related genes(During pregnancy (each trimester) and at birth (cord blood))
研究者
Chi-Man Kuok
Neonatologist
Far Eastern Memorial Hospital