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Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study

2026年5月27日 更新者：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.

調査の概要

状態

募集

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

240

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 台湾
      • New Taipei City、台湾
        • 募集
        • Far Eastern Memorial Hospital
      • New Taipei City、台湾
        • まだ募集していません
        • Far Eastern Memorial Hospital
        • コンタクト：
          • Far Eastern Memorial Hospital
          • 電話番号：+886 2 8966 7000

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

120 pregnant women and their 120 newborns/infants

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
FEMHPregnancy cohort
Throughout pregnancy, delivery, and infant follow-up at FEMH

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Ｍaternal methyl-nutrient and other nutrition status
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Plasma homocysteine concentration
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

その他の成果指標

結果測定
メジャーの説明
時間枠
Dietary intake and diet quality
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Far Eastern Memorial Hospital

協力者

Fu Jen Catholic University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月27日

一次修了 (推定)

2029年1月18日

研究の完了 (推定)

2029年1月18日

試験登録日

最初に提出

2026年4月20日

QC基準を満たした最初の提出物

2026年4月28日

最初の投稿 (実際)

2026年5月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月29日

QC基準を満たした最後の更新が送信されました

2026年5月27日

最終確認日

2026年1月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 114224-F

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いいえ

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