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Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study

27 de mayo de 2026 actualizado por: Chi-Man Kuok, Far Eastern Memorial Hospital

Maternal Methyl-Nutrient Status During Pregnancy and Its Association With Infant Neurodevelopment: Exploring Potential Mechanisms

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

240

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Taiwán
      • New Taipei City, Taiwán
        • Reclutamiento
        • Far Eastern Memorial Hospital
      • New Taipei City, Taiwán
        • Aún no reclutando
        • Far Eastern Memorial Hospital
        • Contacto:
          • Far Eastern Memorial Hospital
          • Número de teléfono: +886 2 8966 7000

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

120 pregnant women and their 120 newborns/infants

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
FEMHPregnancy cohort
Throughout pregnancy, delivery, and infant follow-up at FEMH

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Ｍaternal methyl-nutrient and other nutrition status
Periodo de tiempo: 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
From enrollment to delivery (approximately 9 months)
Birth anthropometric measurements of the newborn
Periodo de tiempo: 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).
At birth
Infant neurodevelopmental outcomes
Periodo de tiempo: 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
At 6, 12, and 24 months of age

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Plasma homocysteine concentration
Periodo de tiempo: During pregnancy (each trimester) and at birth (cord blood)
Plasma homocysteine levels (µmol/L) will be measured using standard enzymatic assays.
During pregnancy (each trimester) and at birth (cord blood)
Plasma trimethylamine N-oxide (TMAO) concentration
Periodo de tiempo: During pregnancy (each trimester) and at birth (cord blood)
Plasma TMAO levels (ng/mL, µmol/L)will be measured using enzyme-linked immunosorbent assay (ELISA) kit.
During pregnancy (each trimester) and at birth (cord blood)
Global DNA methylation levels
Periodo de tiempo: During pregnancy (each trimester) and at birth (cord blood)
DNA methylation status (%) will be assessed using LINE-1 methylation analysis
During pregnancy (each trimester) and at birth (cord blood)
Gut microbiota composition
Periodo de tiempo: During pregnancy (each trimester), at birth (meconium), and at 4, 6, 12, and 24 months of age
Gut microbiota composition will be analyzed using 16S rRNA gene sequencing and reported as relative abundance and diversity indices
During pregnancy (each trimester), at birth (meconium), and at 4, 6, 12, and 24 months of age
Genetic polymorphisms related to methyl metabolism
Periodo de tiempo: During pregnancy
Genetic polymorphisms (e.g., MTHFR, PEMT) will be assessed using genotyping methods and reported as genotype frequencies (%)
During pregnancy
Expression levels of neurodevelopment-related genes
Periodo de tiempo: During pregnancy (each trimester) and at birth (cord blood)
Gene expression levels will be measured using RT-qPCR and report as relative expression levels
During pregnancy (each trimester) and at birth (cord blood)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Dietary intake and diet quality
Periodo de tiempo: From enrollment through pregnancy to 4 months postpartum
Dietary intake will be assessed using a Food Frequency Questionnaire (FFQ) and 3-day dietary records, including assessment of nutrient intake (grams/day ,mg/day)and dietary patterns. Diet quality will be derived from these data
From enrollment through pregnancy to 4 months postpartum

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Far Eastern Memorial Hospital

Colaboradores

Fu Jen Catholic University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

27 de mayo de 2026

Finalización primaria (Estimado)

18 de enero de 2029

Finalización del estudio (Estimado)

18 de enero de 2029

Fechas de registro del estudio

Enviado por primera vez

20 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de abril de 2026

Publicado por primera vez (Actual)

6 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de mayo de 2026

Última verificación

1 de enero de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 114224-F

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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