Effects of early life soy exposure on bone growth and gut health
Study of the Effects of Soy Exposure in Early Life on Bone Development and Gut Microbiota
The Hong Kong Polytechnic University · NCT05763589
This study looks at how eating soy during early life affects bone growth and gut health in infants by examining samples from mothers and their children.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 3 Years to 45 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05763589 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how soy consumption during early life influences gut microbiota and bone development in infants. Researchers will analyze clinical samples from mother-child pairs in the SMART Gen Hong Kong cohort to explore the relationship between maternal soy intake and the child's bone growth and gut microbiome composition. The primary outcomes include measurements of bone mineral density and markers of bone formation, while secondary outcomes focus on gut microbiome profiles and metabolites. The study aims to provide insights into the potential benefits of soy in 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 newborns.
Not a fit: Patients with significant medical conditions or chronic gastrointestinal diseases 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 relationship between gut microbiota and bone health is being explored, this specific approach focusing on early life soy exposure is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for healthy pregnant women: 1. Chinese mothers aged 18 - 45 years who were in the first trimester of pregnancy 2. Singleton pregnancy 3. 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: 1. 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 2. History of chronic inflammatory or neoplastic diseases involving the gastrointestinal tract (e.g. inflammatory bowel disease, coeliac disease, colorectal cancer) 3. Significant pregnancy complications, such as intrauterine foetal demise/stillbirth, extreme prematurity, or pre-labour rupture of membranes before 24 weeks 4. Mother with mental incapacity such that they are not able to give informed consent 5. Foetal chromosomal or clinically significant structural abnormalities 6. The current pregnancy is a conception through either sperm or ovum donation
Where this trial is running
Hong Kong
- The Hong Kong Polytechnic University — Hong Kong, China (RECRUITING)
Study contacts
- Principal investigator: Man Sau Wong, PhD — The Hong Kong Polytechnic University
- Study coordinator: Wing Wa Ho, bachelor
- Email: wing-wa.ho@polyu.edu.hk
- Phone: 85234008806
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