Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study
27. Mai 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
240
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: CHI MAN KUOK
- Telefonnummer: (+886) 952289592
- E-Mail: carmentoe@hotmail.com
Studienorte
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New Taipei City, Taiwan
- Rekrutierung
- Far Eastern Memorial Hospital
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New Taipei City, Taiwan
- Noch keine Rekrutierung
- Far Eastern Memorial Hospital
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Kontakt:
- Far Eastern Memorial Hospital
- Telefonnummer: +886 2 8966 7000
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Ja
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
120 pregnant women and their 120 newborns/infants
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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FEMHPregnancy cohort
Throughout pregnancy, delivery, and infant follow-up at FEMH
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Ｍaternal methyl-nutrient and other nutrition status
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Plasma homocysteine concentration
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Dietary intake and diet quality
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
27. Mai 2026
Primärer Abschluss (Geschätzt)
18. Januar 2029
Studienabschluss (Geschätzt)
18. Januar 2029
Studienanmeldedaten
Zuerst eingereicht
20. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. April 2026
Zuerst gepostet (Tatsächlich)
6. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
29. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
27. Mai 2026
Zuletzt verifiziert
1. Januar 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 114224-F
Plan für individuelle Teilnehmerdaten (IPD)
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