Infant NeurodevelopmentNCT07568561
Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study
An observational study of Infant Neurodevelopment and Nutrition, run by Far Eastern Memorial Hospital at 2 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 days to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Infant Neurodevelopment, Nutrition, Methylation
- How many people
- 240 participants
- Where
- 2 sitesTaiwan
- Study dates
- 27 May 2026to 18 Jan 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 120 pregnant women and their 120 newborns/infants
Who may be able to join
- Aged 20-45 years
- Singleton pregnancy
- Receiving routine prenatal care at the study site and planning to deliver at Far Eastern Memorial Hospital
- ● Newborns delivered by mothers who participate in this study
Who cannot join
- 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
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Not yet recruiting
Far Eastern Memorial Hospital
New Taipei City
Far Eastern Memorial Hospital, +886 2 8966 7000
- Recruiting
Far Eastern Memorial Hospital
New Taipei City
About this study
Official title: 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.
Read the detailed description
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FEMHPregnancy cohort | Throughout pregnancy, delivery, and infant follow-up at FEMH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ｍaternal methyl-nutrient and other nutrition status
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
Measured: From enrollment to delivery (approximately 9 months)
Birth anthropometric measurements of the newborn
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).
Measured: At birth
Infant neurodevelopmental outcomes
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
Measured: At 6, 12, and 24 months of age
Secondary outcomes (6)
Plasma homocysteine concentration
Plasma homocysteine levels (µmol/L) will be measured using standard enzymatic assays.
Measured: During pregnancy (each trimester) and at birth (cord blood)
Plasma trimethylamine N-oxide (TMAO) concentration
Plasma TMAO levels (ng/mL, µmol/L)will be measured using enzyme-linked immunosorbent assay (ELISA) kit.
Measured: During pregnancy (each trimester) and at birth (cord blood)
Global DNA methylation levels
DNA methylation status (%) will be assessed using LINE-1 methylation analysis
Measured: During pregnancy (each trimester) and at birth (cord blood)
Gut microbiota composition
Gut microbiota composition will be analyzed using 16S rRNA gene sequencing and reported as relative abundance and diversity indices
Measured: During pregnancy (each trimester), at birth (meconium), and at 4, 6, 12, and 24 months of age
Genetic polymorphisms related to methyl metabolism
Genetic polymorphisms (e.g., MTHFR, PEMT) will be assessed using genotyping methods and reported as genotype frequencies (%)
Measured: During pregnancy
Expression levels of neurodevelopment-related genes
Gene expression levels will be measured using RT-qPCR and report as relative expression levels
Measured: During pregnancy (each trimester) and at birth (cord blood)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start27 May 2026
- Primary completion18 Jan 2029 (estimated)
- Study completion18 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant NeurodevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fu Jen Catholic University
- Responsible party
- Principal investigator, Chi-Man Kuok, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568561
- Sponsor's protocol ID
- 114224-F
- Status last verified
- Jan 2026
- First submitted
- 20 Apr 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Methyl-Nutrient Status During Pregnancy and Its Association With Infant Neurodevelopment: Exploring Potential Mechanisms
- ClinicalTrials.gov ID
- NCT07568561
- Acronym / sponsor ID
- 114224-F
- Conditions
- Infant Neurodevelopment, Nutrition, Methylation, Birth Outcomes, Pregnancy, Dietary Quality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Collaborators
- Fu Jen Catholic University
- Study start
- 27 May 2026 (actual)
- Primary completion
- 18 Jan 2029 (estimated)
- Study completion
- 18 Jan 2029 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FEMHPregnancy cohort | – | –Throughout pregnancy, delivery, and infant follow-up at FEMH |
Who may qualify
- Ages
- 0 days to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 120 pregnant women and their 120 newborns/infants
Key inclusion criteria (4 listed)
- Aged 20-45 years
- Singleton pregnancy
- Receiving routine prenatal care at the study site and planning to deliver at Far Eastern Memorial Hospital
- ● Newborns delivered by mothers who participate in this study
Key exclusion criteria (6 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ｍaternal methyl-nutrient and other nutrition status
Time frame: 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
Birth anthropometric measurements of the newborn
Time frame: 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).
Infant neurodevelopmental outcomes
Time frame: 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
6 secondary outcomes
Plasma homocysteine concentration
Time frame: During pregnancy (each trimester) and at birth (cord blood)
Plasma trimethylamine N-oxide (TMAO) concentration
Time frame: During pregnancy (each trimester) and at birth (cord blood)
Global DNA methylation levels
Time frame: During pregnancy (each trimester) and at birth (cord blood)
Gut microbiota composition
Time frame: During pregnancy (each trimester), at birth (meconium), and at 4, 6, 12, and 24 months of age
Genetic polymorphisms related to methyl metabolism
Time frame: During pregnancy
Expression levels of neurodevelopment-related genes
Time frame: During pregnancy (each trimester) and at birth (cord blood)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Neurodevelopment and Nutrition, run by Far Eastern Memorial Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHI MAN KUOK ((+886) 952289592, carmentoe@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ｍaternal methyl-nutrient and other nutrition status (time frame: From enrollment to delivery (approximately 9 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.