Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study
27 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Stimato)
240
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: CHI MAN KUOK
- Numero di telefono: (+886) 952289592
- Email: carmentoe@hotmail.com
Luoghi di studio
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New Taipei City, Taiwan
- Reclutamento
- Far Eastern Memorial Hospital
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New Taipei City, Taiwan
- Non ancora reclutamento
- Far Eastern Memorial Hospital
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Contatto:
- Far Eastern Memorial Hospital
- Numero di telefono: +886 2 8966 7000
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Sì
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
120 pregnant women and their 120 newborns/infants
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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FEMHPregnancy cohort
Throughout pregnancy, delivery, and infant follow-up at FEMH
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Ｍaternal methyl-nutrient and other nutrition status
Lasso di tempo: From enrollment to delivery (approximately 9 months)
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Maternal methyl-nutrient status will be assessed using the following measurements:
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From enrollment to delivery (approximately 9 months)
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Birth anthropometric measurements of the newborn
Lasso di tempo: At birth
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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).
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At birth
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Infant neurodevelopmental outcomes
Lasso di tempo: At 6, 12, and 24 months of age
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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
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At 6, 12, and 24 months of age
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Plasma homocysteine concentration
Lasso di tempo: During pregnancy (each trimester) and at birth (cord blood)
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Plasma homocysteine levels (µmol/L) will be measured using standard enzymatic assays.
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During pregnancy (each trimester) and at birth (cord blood)
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Plasma trimethylamine N-oxide (TMAO) concentration
Lasso di tempo: During pregnancy (each trimester) and at birth (cord blood)
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Plasma TMAO levels (ng/mL, µmol/L)will be measured using enzyme-linked immunosorbent assay (ELISA) kit.
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During pregnancy (each trimester) and at birth (cord blood)
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Global DNA methylation levels
Lasso di tempo: During pregnancy (each trimester) and at birth (cord blood)
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DNA methylation status (%) will be assessed using LINE-1 methylation analysis
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During pregnancy (each trimester) and at birth (cord blood)
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Gut microbiota composition
Lasso di tempo: During pregnancy (each trimester), at birth (meconium), and at 4, 6, 12, and 24 months of age
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Gut microbiota composition will be analyzed using 16S rRNA gene sequencing and reported as relative abundance and diversity indices
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During pregnancy (each trimester), at birth (meconium), and at 4, 6, 12, and 24 months of age
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Genetic polymorphisms related to methyl metabolism
Lasso di tempo: During pregnancy
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Genetic polymorphisms (e.g., MTHFR, PEMT) will be assessed using genotyping methods and reported as genotype frequencies (%)
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During pregnancy
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Expression levels of neurodevelopment-related genes
Lasso di tempo: During pregnancy (each trimester) and at birth (cord blood)
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Gene expression levels will be measured using RT-qPCR and report as relative expression levels
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During pregnancy (each trimester) and at birth (cord blood)
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Dietary intake and diet quality
Lasso di tempo: From enrollment through pregnancy to 4 months postpartum
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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
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From enrollment through pregnancy to 4 months postpartum
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
27 maggio 2026
Completamento primario (Stimato)
18 gennaio 2029
Completamento dello studio (Stimato)
18 gennaio 2029
Date di iscrizione allo studio
Primo inviato
20 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
28 aprile 2026
Primo Inserito (Effettivo)
6 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 maggio 2026
Ultimo verificato
1 gennaio 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 114224-F
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .