- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07568561
Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study
27. maj 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
240
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: CHI MAN KUOK
- Telefonnummer: (+886) 952289592
- E-mail: carmentoe@hotmail.com
Studiesteder
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New Taipei City, Taiwan
- Rekruttering
- Far Eastern Memorial Hospital
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New Taipei City, Taiwan
- Ikke rekrutterer endnu
- Far Eastern Memorial Hospital
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Kontakt:
- Far Eastern Memorial Hospital
- Telefonnummer: +886 2 8966 7000
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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FEMHPregnancy cohort
Throughout pregnancy, delivery, and infant follow-up at FEMH
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Maternal methyl-nutrient and other nutrition status
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Plasma homocysteine concentration
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Dietary intake and diet quality
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. maj 2026
Primær færdiggørelse (Anslået)
18. januar 2029
Studieafslutning (Anslået)
18. januar 2029
Datoer for studieregistrering
Først indsendt
20. april 2026
Først indsendt, der opfyldte QC-kriterier
28. april 2026
Først opslået (Faktiske)
6. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. maj 2026
Sidst verificeret
1. januar 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 114224-F
Plan for individuelle deltagerdata (IPD)
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Kliniske forsøg med Graviditet
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King's College Hospital NHS TrustEuropean Association for the Study of the LiverRekrutteringCirrhose, lever | HELLP syndrom | Intrahepatisk kolestase af graviditet | Graviditetssygdom | AFLP - Acute Fatty Lever of PregnancyDet Forenede Kongerige