About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 20-45 years
Singleton pregnancy
Receiving routine prenatal care at the study site and planning to deliver at Far Eastern Memorial Hospital
Disqualifiers
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
Diagnosed with congenital anomalies, epilepsy, or severe brain injury
Trial population
120 pregnant women and their 120 newborns/infants
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Maternal methyl-nutrient and other nutrition status
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
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
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
Secondary outcomes
Plasma homocysteine concentration
Plasma homocysteine levels (µmol/L) will be measured using standard enzymatic assays.
Plasma trimethylamine N-oxide (TMAO) concentration
Plasma TMAO levels (ng/mL, µmol/L)will be measured using enzyme-linked immunosorbent assay (ELISA) kit.
Global DNA methylation levels
DNA methylation status (%) will be assessed using LINE-1 methylation analysis
Gut microbiota composition
Gut microbiota composition will be analyzed using 16S rRNA gene sequencing and reported as relative abundance and diversity indices
Other outcomes
Dietary intake and diet quality
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
Sponsors and contacts
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Far Eastern Memorial Hospital
Lead sponsor
Fu Jen Catholic University
Collaborator