Human Milk Nutrients and Infants' Health Outcomes in South China
1 other identifier
observational
80
1 country
1
Brief Summary
The purpose of this study is to investigate the associations between human milk nutrients and infants' health outcomes in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 6, 2022
CompletedFirst Submitted
Initial submission to the registry
June 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedMarch 6, 2025
March 1, 2025
1.4 years
June 20, 2022
March 3, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
The growth of children
The physical growth and body composition of children will be checked by physical examination.
18 month
The cognitive development of children
The brain developments of children will be obtained by the Griffith Developmental Assessment Scale.
18 month
Gut microbiota
Gut microbiota of children will be examined by the analysis of 16S rDNA and metagenomic.
6 month
Secondary Outcomes (5)
General demographic materials
14 month
Dietary and lifestyle information
3 month
Behavior problems
18 month
Allergic assessment
18 month
Sleep assessment
18 month
Eligibility Criteria
Children of this study will be recruited from lactating women provided human milk samples before.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huilian Zhulead
Study Sites (1)
Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Related Publications (1)
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.
PMID: 40986082DERIVED
Biospecimen
Faeces were retented.
Study Officials
- STUDY CHAIR
Huilian Zhu, Professor
Sun Yat-sen University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 20, 2022
First Posted
June 27, 2022
Study Start
June 6, 2022
Primary Completion
October 30, 2023
Study Completion
December 30, 2023
Last Updated
March 6, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share