Study of the Effects of Soy Exposure in Early Life on Bone Development and Gut Microbiota
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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 development of osteoporosis by 13 years. The determinants of peak bone mass include both genetic (such as gender and race) which accounts for up to 75% of bone mass, and lifestyle factors (such as diet and physical activities) which accounts for the remaining 25%. Lifestyle factors play important roles in optimizing bone accrual during growth, for example, dietary Ca was shown to predict 10-15% of skeletal Ca retention during adolescence while exercise could enhance the effects of dietary Ca via enhancing bone geometry.
Recent studies suggest that gut microbiota is a key regulator of bone mass. Experimental studies showed that bone mineral density (BMD) was altered by ablation of gut microbiota in germ-free mice as well as in mice treated with antibiotics. Moreover, administration of antibiotic either at birth or at weaning was shown to exert a longer-lasting effect on BMD in female C57BL/6 mice at 20 weeks of age but not in male mice. This finding suggests altering microbiota at a critical developmental window has a long-term impact on bone health. Indeed, the establishment of gut microbiota in human is believed to take place beginning at birth in which bacteria from mother will immediately colonize the gastrointestinal (GI) tract of the newborn until its stabilization towards an adult-like configuration during the 3-year period after birth. The development of gut microbiota during this critical period is likely to be affected by different environmental factors, including breastfeeding, diet and antibiotic treatment. Thus, establishing optimal gut microbiota during critical developmental period is a potential mean for enhancing bone health.
The composition of the gut microbiota has been reported to be altered by animal-based diet, Mediterranean diet as well as different dietary factors such as dietary/prebiotic fiber and probiotics. For example, galacto-oligosaccharides is a prebiotic fiber that could increase the proportion of bifidobacteria in GI tract, increase short-chain fatty acids (SCFAs) and decrease cecal pH, thereby increasing mineral absorption, bone biomechanical strength as well as BMD of growing male rats. Similarly, the probiotics Lactobacillus rhamnosus GG was shown to reduce gut permeability, decrease intestinal and bone marrow inflammation, and completely protect against sex steroid-deficiency associated bone loss. The differences in gut microbiota composition is also thought to contribute to the differences in the person's ability to produce equol, a nonsteroidal estrogen metabolized by bacteria from soy isoflavones, that account for the estrogenic actions of soy in bone. Such differences might account for effectiveness of soy isoflavones for protection against bone loss in Asian, but not Western, populations. The ability to produce equol in healthy infants was found to be developmentally regulated and affected by diet composition, in which only trace amounts of equol could be detected in infant plasma at 6 months of age possibly due to the lack of developed gut microflora. Subsequent studies indicate the importance of habitual diets in contributing to equol production in which equol-producers appear to have a higher intake of carbohydrate and dietary fiber, soy and plant protein and lower intake of fat than non-producers. Thus, it is of high importance to identify dietary factors that can optimize the development of gut microbiota and the production of equol for optimizing bone health.
Soy-containing diets are reported to be dietary factors in early life that optimize bone acquisition. Early-life soy exposure was found to promote bone growth and neonatal administration of soy isoflavones could attenuate bone deterioration during adulthood. However, the impact of soy components on gut microbiota in these studies was not characterized, and it is unclear if these bone acquisition effects are related to the actions of soy on gut microbiota composition. Moreover, it should be noted that different soy preparations were being used in different preclinical and clinical studies, including soy isoflavones extract or purified compounds (genistein and daidzein), soy protein isolates with isoflavones, whole soy products (soymilk and other soybean products). The differences in soy preparations might have different effects on the gut microflora, and hence on bone. Indeed, apart from being dietary sources of protein and isoflavones, soybeans are also rich in fibers (polysaccharides and oligosaccharides). Soybean oligosaccharides (SBOS), have been reported to increase the population of bifidobacteria in human fecal samples. In addition, soluble fibers from soy could be fermented by colonic bacteria, leading to SCFAs formation, thereby potentially exerting beneficial effects on bone. Thus, it will be important to identify which dietary components of soy (soy fiber or soy isoflavones) exposed at early life will achieve optimal bone acquisition and gut microbiota.
Alteration of the composition of gut microbiota at early life by dietary soy appears to be a promising approach for enhancing bone growth. However, more studies are needed to address the following questions before any dietary advice for the use of soy in optimizing bone growth can be made: When will be the best time (before birth, nursing or after weaning) for dietary soy exposure for optimal gut microbiota and bone growth? Which component in soy (fiber or isoflavones, or both) offer(s) better effects on bone growth via the modulation of gut microbiome? Which microbes altered by soy are associated with optimal bone growth? Which biomarkers/metabolites (SCFAs, equol, or novel metabolites) can account for the optimal bone growth upon soy exposure?
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Wing Wa Ho, bachelor
- Phone Number: 85234008806
- Email: wing-wa.ho@polyu.edu.hk
Study Contact Backup
- Name: Ka Hei Kenneth Lo
- Phone Number: 85234008778
- Email: kenneth.kh.lo@polyu.edu.hk
Study Locations
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-
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Hong Kong, China
- The Hong Kong Polytechnic University
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone mineral density
Time Frame: through study completion, an average of 1 year
|
dynamic bone formation parameters; mRNA expression of bone markers
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through study completion, an average of 1 year
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gut microbiome profile
Time Frame: through study completion, an average of 1 year
|
metabolomic profile in serum, urine or feces; correlation between soy-induced gut microbiota or metabolites and bone growth.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Man Sau Wong, PhD, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- NTEC-2021-0791
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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