NCT07568561

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started May 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 6, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2029

Last Updated

May 6, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

April 20, 2026

Last Update Submit

April 28, 2026

Conditions

Infant NeurodevelopmentNutritionMethylationBirth OutcomesPregnancyDietary QualityDietary Intake AssessmentHomocysteineTrimethylamine N-oxide (TMAO)

Outcome Measures

Primary Outcomes (3)

  • 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

    From enrollment to delivery (approximately 9 months)

  • 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).

    At birth

  • 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

    At 6, 12, and 24 months of age

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Other Outcomes (1)

  • Dietary intake and diet quality

    From enrollment through pregnancy to 4 months postpartum

Study Arms (1)

FEMHPregnancy cohort

Throughout pregnancy, delivery, and infant follow-up at FEMH

Eligibility Criteria

Age0 Days - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

120 pregnant women and their 120 newborns/infants

You may qualify if:

  • Aged 20-45 years
  • Singleton pregnancy
  • Receiving routine prenatal care at the study site and planning to deliver at Far Eastern Memorial Hospital

You may not qualify if:

  • 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
  • ● Newborns delivered by mothers who participate in this study
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Location

Central Study Contacts

CHI MAN KUOK

CONTACT

(+886) 952289592carmentoe@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neonatologist

Study Record Dates

First Submitted

April 20, 2026

First Posted

May 6, 2026

Study Start

May 6, 2026

Primary Completion (Estimated)

January 18, 2029

Study Completion (Estimated)

January 18, 2029

Last Updated

May 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)