Effects of soy on bone growth and gut health in infants
Study of the Effects of Soy Exposure in Early Life on Bone Development and Gut Microbiota
Chinese University of Hong Kong · NCT05213780
This study is testing whether eating soy during pregnancy can help improve bone growth and gut health in infants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 3 Years to 45 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05213780 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how early-life exposure to soy affects gut microbiota and bone development in infants. Researchers will analyze clinical samples from mother-child pairs to explore the relationship between maternal soy intake and the child's bone growth and gut microbiome composition. The primary outcomes include measuring bone mineral density and dynamic bone formation parameters, while secondary outcomes focus on gut microbiome profiles and metabolomic analyses. The study aims to provide insights into the potential benefits of soy consumption during early life for optimizing bone health.
Who should consider this trial
Good fit: Ideal candidates include healthy Chinese pregnant women aged 18-45 in their first trimester and their infants.
Not a fit: Patients with significant medical conditions or pregnancy complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for using soy preparations in early life to enhance bone growth and gut health.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated a link between gut microbiota and bone health, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for healthy pregnant women: * Chinese mothers aged 18 - 45 years who were in the first trimester of pregnancy * Singleton pregnancy * Participate voluntarily and capable of giving informed consent Inclusion Criteria for babies: - The baby of enrolled pregnant women and parents signed written informed consent prior to the initiation of this study. Exclusion Criteria: * Significant medical conditions especially those required long term medications, such as oral steroid, antihypertensive drugs, diabetic medications and lipid-lowering agents, during or before pregnancy * History of chronic inflammatory or neoplastic diseases involving the gastrointestinal tract (e.g. inflammatory bowel disease, coeliac disease, colorectal cancer) * Significant pregnancy complications, such as intrauterine foetal demise/stillbirth, extreme prematurity, or pre-labour rupture of membranes before 24 weeks * Mother with mental incapacity such that they are not able to give informed consent * Foetal chromosomal or clinically significant structural abnormalities * The current pregnancy is a conception through either sperm or ovum donation
Where this trial is running
Hong Kong
- Department of Paediatrics, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Study coordinator: Ting-Fan Leung, MBChB, MD
- Email: tfleung@cuhk.edu.hk
- Phone: 35052981
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Child Development, Soy isoflavones, Bone development, Soy oligonucleotide, Gut microbiome, Prebiotics, Postbiotics, Early life exposure