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Study of the Effects of Soy Exposure in Early Life on Bone Development and Gut Microbiota

StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Trial completed
    • Final enrollment: 105 participants (planned 240)
    • Eligibility criteria expanded, about 9 words
  2. Primary and study completion dates: Jun 30, 2025 to May 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  3. Primary completion date: Jun 30, 2024 to Jun 30, 2025v4
  4. Primary completion date: Jun 30, 2023 to Jun 30, 2024v3
  5. Study description shortened, about 4 wordsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 exposure to soy optimize bone growth via the alteration of gut microbiota composition. Clinical samples from mother-child pairs recruited into the SMART Gen Hong Kong cohort will be used to examine the association between maternal soy intake with infant gut microbiota and child's bone development. Primary outcome: Bone mineral density; dynamic bone formation parameters; messenger ribonucleic acid (mRNA) expression of bone markers. Secondary outcome: Gut microbiome profile; metabolomic profile in serum, urine or feces; correlation between soy-induced gut microbiota or metabolites and bone growth. The investigators expect that early life exposure to soy will improve bone growth via gut microbiota and provide scientific evidences for the use of soy preparation in early life as a preventive measure for optimizing bone health.
Trial Details
NCT Number NCT05763589
Lead Sponsor The Hong Kong Polytechnic University
Collaborators: Chinese University of Hong Kong
Conditions
(from sponsor)		 Child Development
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov