Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 2, 2021
Open Peer Review Period: May 2, 2021 - Jun 27, 2021
Date Accepted: Aug 10, 2021
(closed for review but you can still tweet)
Modulation of bone/joint biomarkers, gut microbiota and inflammation status by synbiotic (pre- and probiotics) and weight-bearing exercise; human study protocol for a randomised controlled trial COPES (COmbination of Physical Exercise and Synbiotics) 4 Bones
ABSTRACT
Background:
There is strong evidence suggesting that prebiotics and probiotics regulate the gut microbiota, reducing inflammation and thereby potentially improving bone health status. Likewise, mechanistic evidence suggests that either low impact or high impact weight-bearing exercises improve body composition and consequently bone mineral density (BMD) in osteoporosis and osteoarthritis.
Objective:
The objective of this randomised trial is to investigate the effect of a synbiotic (probiotic + prebiotic) supplementation, exercise intervention or a combination of both on the gut microbiota, inflammation and bone biomarkers in postmenopausal women.
Methods:
A total of 160 New Zealand postmenopausal women will be recruited and randomised to one of four interventions/treatments; control, synbiotic supplement, exercise intervention or synbiotic + exercise for 12 weeks. The primary outcome measure is the bone/joint biomarkers at baseline and week 12, while gut microbiota profile and inflammatory cytokine measurements will serve as the secondary outcome measures at baseline and week 12. Baseline data and exercise history will be used to assess, allocate and stratify participants into treatment measures.
Results:
No results yet.
Conclusions:
To the best of our knowledge, this will be the first randomized control trial to analyse the effect of both a synbiotic supplement and an exercise intervention in postmenopausal women. Depending on the results obtained; a combination of synbiotic supplement and exercise might serve as a non-invasive approach to manage and/or improve body composition and bone health in postmenopausal women. Clinical Trial: Australian New Zealand Clinical Trials Registry (ANZCTR)-ACTRN12620000998943p
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