Status:
UNKNOWN
Soy Exposure on Bone Development and Gut Microbiota
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
The Hong Kong Polytechnic University
Conditions:
Child Development
Eligibility:
All Genders
3-45 years
Brief Summary
In this project, the investigators aim to investigate the effects of soy consumption at early life on the development of gut microbiota and bone growth. The hypothesis to be tested is that early-life ...
Detailed Description
Peak bone mass, achieved at the end of growth period, plays a critical role in the risk of osteoporotic fractures occurring later in life. A 10% increase in peak bone mass was predicted to delay the d...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05213780
Start Date
September 1 2022
End Date
August 31 2025
Last Update
October 4 2023
Active Locations (1)
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1
Department of Paediatrics, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin
Hong Kong, Hong Kong, 0000