HealthyNCT05432180
Human Milk Nutrients and Infants' Health Outcomes in South China
An observational study of Healthy, run by Huilian Zhu at 1 site in China.
Trial summary
The purpose of this study is to investigate the associations between human milk nutrients and infants' health outcomes in China. Read more about this study
- Who is it for?
- Ages 4 to 5 years
- Conditions the study is for
- Healthy
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2022to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children of this study will be recruited from lactating women provided human milk samples before.
Who may be able to join
- age 4-5 years
- healthy children
- breastfeeding between 0 to 400 days of age
- human milk components in human milk being determined
- sign informed consent
Who cannot join
- children with severe chronic diseases, such as tumor, severe digestive diseases, kidney diseases
- gestational diabetes, hypertension and other metabolic diseases
- children with mental system diseases
- children with congenital and genetic diseases
- children with infectious diseases, eg, upper respiratory tract infection or diarrhea
- antibiotic or other drugs influencing intestinal flora being taken within 45 days
- Withdraw withdraw informed consent serious violation of the scheme no longer meet the research criteria because of health factors or accidents
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the associations between human milk nutrients and infants' health outcomes in China.
Read the detailed description
Human milk components are beneficial to the growth and development of infants, such as phospholipids, gangliosides, sialic acids, choline, oligosaccharide and so on. However, studies on the associations between human milk components and infants' outcomes are limited. Therefore, this study is designed to investigate the relationship between Chinese human milk components and the growth and development of infants.
- Conditions
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
The growth of children
The physical growth and body composition of children will be checked by physical examination.
Measured: 18 month
The cognitive development of children
The brain developments of children will be obtained by the Griffith Developmental Assessment Scale.
Measured: 18 month
Gut microbiota
Gut microbiota of children will be examined by the analysis of 16S rDNA and metagenomic.
Measured: 6 month
Secondary outcomes (5)
General demographic materials
The general demographic materials of parents and children will be obtained by questionnaire.
Measured: 14 month
Dietary and lifestyle information
Dietary and lifestyle information of children will be obtained by questionnaire.
Measured: 3 month
Behavior problems
The behavior problems are collected by Child Behavior Checklist.
Measured: 18 month
Allergic assessment
Allergic assessments of children will be conducted by questionnaire.
Measured: 18 month
Sleep assessment
Sleep assessment of infants will be conducted by The Children's Sleep Health Questionnaire.
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start6 Jun 2022
- Primary completion30 Oct 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huilian Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huilian Zhu, Sun Yat-sen University
- Investigators
- Huilian Zhu, Professor, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432180
- Sponsor's protocol ID
- MUAI-2022
- Status last verified
- Mar 2025
- First submitted
- 20 Jun 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang MT, Lan QY, Pan C, Huang SY, Huang ZH, Li MC, Li Z, Li F, Li X, Zou JP, Chen HQ, Qiu YZ, Song S, Mao YY, Zhu HL. Long-term cognitive benefits of human milk phospholipids in breastfed children at preschool age: results from MUAI study. Eur J Nutr. 2025 Sep 23;64(7):283. doi: 10.1007/s00394-025-03801-y.
PubMed 40986082
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Milk Nutrients and Infants' Health Outcomes in South China
- ClinicalTrials.gov ID
- NCT05432180
- Acronym / sponsor ID
- MUAI-2022
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Huilian ZhuUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 27 Jun 2022 (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.
The purpose of this study is to investigate the associations between human milk nutrients and infants' health outcomes in China.
Detailed description
Human milk components are beneficial to the growth and development of infants, such as phospholipids, gangliosides, sialic acids, choline, oligosaccharide and so on. However, studies on the associations between human milk components and infants' outcomes are limited. Therefore, this study is designed to investigate the relationship between Chinese human milk components and the growth and development of infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children of this study will be recruited from lactating women provided human milk samples before.
Key inclusion criteria (5 listed)
- age 4-5 years
- healthy children
- breastfeeding between 0 to 400 days of age
- human milk components in human milk being determined
- sign informed consent
Key exclusion criteria (7 listed)
- children with severe chronic diseases, such as tumor, severe digestive diseases, kidney diseases
- gestational diabetes, hypertension and other metabolic diseases
- children with mental system diseases
- children with congenital and genetic diseases
- children with infectious diseases, eg, upper respiratory tract infection or diarrhea
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
The growth of children
Time frame: 18 month
The physical growth and body composition of children will be checked by physical examination.
The cognitive development of children
Time frame: 18 month
The brain developments of children will be obtained by the Griffith Developmental Assessment Scale.
Gut microbiota
Time frame: 6 month
Gut microbiota of children will be examined by the analysis of 16S rDNA and metagenomic.
5 secondary outcomes
General demographic materials
Time frame: 14 month
Dietary and lifestyle information
Time frame: 3 month
Behavior problems
Time frame: 18 month
Allergic assessment
Time frame: 18 month
Sleep assessment
Time frame: 18 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Derived from this study: PubMed 40986082Yang MT, Lan QY, Pan C, Huang SY, Huang ZH, Li MC, Li Z, Li F, Li X, Zou JP, Chen HQ, Qiu YZ, Song S, Mao YY, Zhu HL. Long-term cognitive benefits of human milk phospholipids in breastfed children at preschool age: results from MUAI study. Eur J Nutr. 2025 Sep 23;64(7):283. doi: 10.1007/s00394-025-03801-y.
- 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. This study is not recruiting at the moment.
Huilian Zhu, Professor study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Huilian Zhu at 1 site in China.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The growth of children (time frame: 18 month). 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?
On the ClinicalTrials.gov record for NCT05432180, which also lists 1 linked publication.
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 6 Mar 2025.