Soy Exposure on Bone Development and Gut Microbiota

NCT05213780 | Unknown

• 1 other identifier: NTEC-2021-0791
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Child Development

Keywords

Soy isoflavones; Bone development; Soy oligonucleotide; Gut microbiome; Prebiotics; Postbiotics; Early life exposure; Metabolomics; Short-chain fatty acid; Equol

Outcome Measures

Primary Outcomes (2)

• Dynamic bone formation parameters

  as important surrogate biomarkers for bone mineral density

  through study completion, an average of 1 year

• Messenger RNA expression of bone markers

  reflect changes in the mechanisms leading to altered bone mineral density

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Gut microbiome profile

  through study completion, an average of 1 year

• Correlation between soy-induced gut microbiota or metabolites and bone growth

  through study completion, an average of 1 year

• Metabolomic profile in serum, urine or feces

  through study completion, an average of 1 year

Interventions

No intervention is involved OTHER

No intervention is involved

Eligibility Criteria

• Age: 3 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

120 mother-child pairs

You may qualify if:

• Chinese mothers aged 18 - 45 years who were in the first trimester of pregnancy
• Singleton pregnancy
• Participate voluntarily and capable of giving informed consent
• \- The baby of enrolled pregnant women and parents signed written informed consent prior to the initiation of this study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

Department of Paediatrics, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin

Hong Kong, 0000, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

At around 36-month postpartum, mother and child will provide one urine sample (10-15 ml) for assessing equol production. Bone assessment will be performed when the child is at the age of 6 years old in a designated site at the Prince of Wales Hospital in Shatin: The child will undergo high-resolution peripheral quantitative computed tomography (HR-pQCT) to measure the cross-sectional geometry, volumetric bone mineral density, and bone microstructure at the distal radius of the non-dominant forearm. The scan region is 4% of the forearm length proximal to the lateral edge of the radial joint surface of the wrist. (Optional) The child will provide blood (2-3 ml) and urine sample (10-15 ml) for measuring bone markers.

Central Study Contacts

Ting-Fan Leung, MBChB, MD

CONTACT

35052981; tfleung@cuhk.edu.hk

Man-Sau Wong, PhD

CONTACT

man-sau.wong@polyu.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alice Ho Miu Ling Nethersole Charity Foundation Professor of Paediatrics

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 28, 2022
• Study Start: September 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2025
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 12 months following completion of this study
• Access Criteria: Upon contact with and agreement reached with the Principal Investigator

Locations

HK (1)