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Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study

27. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

240

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Taiwan
      • New Taipei City, Taiwan
        • Rekruttering
        • Far Eastern Memorial Hospital
      • New Taipei City, Taiwan
        • Har ikke rekruttert ennå
        • Far Eastern Memorial Hospital
        • Ta kontakt med:
          • Far Eastern Memorial Hospital
          • Telefonnummer: +886 2 8966 7000

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

120 pregnant women and their 120 newborns/infants

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
FEMHPregnancy cohort
Throughout pregnancy, delivery, and infant follow-up at FEMH

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Ｍaternal methyl-nutrient and other nutrition status
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Plasma homocysteine concentration
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Dietary intake and diet quality
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Far Eastern Memorial Hospital

Samarbeidspartnere

Fu Jen Catholic University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. mai 2026

Primær fullføring (Antatt)

18. januar 2029

Studiet fullført (Antatt)

18. januar 2029

Datoer for studieregistrering

Først innsendt

20. april 2026

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. mai 2026

Sist bekreftet

1. januar 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 114224-F

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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