Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-45
SponsorFar Eastern Memorial Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

240 Participants
are grouped into 1 trial group
Group A: FEMHPregnancy cohort

Trial outcomes

Primary outcomes

1

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

Time frame
From enrollment to delivery (approximately 9 months)
2

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).

Time frame
At birth
3

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

Time frame
At 6, 12, and 24 months of age

Secondary outcomes

1

Plasma homocysteine concentration

Plasma homocysteine levels (µmol/L) will be measured using standard enzymatic assays.

Time frame
During pregnancy (each trimester) and at birth (cord blood)
2

Plasma trimethylamine N-oxide (TMAO) concentration

Plasma TMAO levels (ng/mL, µmol/L)will be measured using enzyme-linked immunosorbent assay (ELISA) kit.

Time frame
During pregnancy (each trimester) and at birth (cord blood)
3

Global DNA methylation levels

DNA methylation status (%) will be assessed using LINE-1 methylation analysis

Time frame
During pregnancy (each trimester) and at birth (cord blood)
4

Gut microbiota composition

Gut microbiota composition will be analyzed using 16S rRNA gene sequencing and reported as relative abundance and diversity indices

Time frame
During pregnancy (each trimester), at birth (meconium), and at 4, 6, 12, and 24 months of age

Other outcomes

1

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

Time frame
From enrollment through pregnancy to 4 months postpartum

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Far Eastern Memorial Hospital

Lead sponsor

Fu Jen Catholic University

Collaborator