Modulation of Bone and Joint Biomarkers, Gut Microbiota, and Inflammation Status by Synbiotic Supplementation and Weight-Bearing Exercise: Human Study Protocol for a Randomized Controlled Trial

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dc.citation.issue10
dc.citation.volume10
dc.contributor.authorIlesanmi-Oyelere BL
dc.contributor.authorRoy NC
dc.contributor.authorKruger MC
dc.contributor.editorEysenbach G
dc.coverage.spatialCanada
dc.date.accessioned2023-07-12T01:58:32Z
dc.date.accessioned2023-09-04T01:40:42Z
dc.date.available2021-10-26
dc.date.available2023-07-12T01:58:32Z
dc.date.available2023-09-04T01:40:42Z
dc.date.issued2021-10-26
dc.date.updated2023-07-11T04:38:10Z
dc.description(c) The Author/s
dc.description.abstractBACKGROUND: There is strong evidence suggesting that prebiotics and probiotics regulate gut microbiota, reducing inflammation and thereby potentially improving bone health status. Similarly, mechanistic evidence suggests that either low-impact or high-impact weight-bearing exercises improve body composition and consequently increase bone mineral density in individuals with osteoporosis and osteoarthritis. OBJECTIVE: This study aims to investigate the effects of a synbiotic (probiotic+prebiotic) supplementation, an exercise intervention, or a combination of both on gut microbiota, inflammation, and bone biomarkers in postmenopausal women. METHODS: A total of 160 postmenopausal women from New Zealand will be recruited and randomized to one of four interventions or treatments for 12 weeks: control, synbiotic supplementation, exercise intervention, or synbiotic supplementation and exercise. The primary outcome measure is the bone and joint biomarkers at baseline and week 12, whereas the 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: Recruitment of participants will begin in September 2021, and the anticipated completion date is June 2022. CONCLUSIONS: To the best of our knowledge, this will be the first randomized controlled trial to analyze the effects of both a synbiotic supplement and an exercise intervention in postmenopausal women. On the basis of the results obtained, a combination of synbiotic supplements and exercise might serve as a noninvasive approach to manage and/or improve body composition and bone health in postmenopausal women. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620000998943p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380336&isClinicalTrial=False.
dc.description.confidentialfalse
dc.edition.editionOctober 2021
dc.format.extente30131-
dc.identifiere30131
dc.identifierv10i10e30131
dc.identifierhttps://www.ncbi.nlm.nih.gov/pubmed/34698648
dc.identifier.citationIlesanmi-Oyelere BL, Roy NC, Kruger MC. (2021). Modulation of Bone and Joint Biomarkers, Gut Microbiota, and Inflammation Status by Synbiotic Supplementation and Weight-Bearing Exercise: Human Study Protocol for a Randomized Controlled Trial.. JMIR Res Protoc. 10. 10. (pp. e30131-).
dc.identifier.doi10.2196/30131
dc.identifier.eissn1929-0748
dc.identifier.elements-typejournal-article
dc.identifier.harvestedMassey_Dark
dc.identifier.issn1929-0748
dc.identifier.urihttp://hdl.handle.net/10179/19868
dc.languageeng
dc.publisherJMIR Publications
dc.publisher.urihttps://www.researchprotocols.org/2021/10/e30131
dc.relation.isPartOfJMIR Res Protoc
dc.rightsCC BY 4.0
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectBMD
dc.subjectbone and joint biomarkers
dc.subjectcytokines
dc.subjectgut microbiota
dc.subjectinflammation
dc.subjectsynbiotic (prebiotic+probiotic)
dc.subjectweight-bearing exercise
dc.titleModulation of Bone and Joint Biomarkers, Gut Microbiota, and Inflammation Status by Synbiotic Supplementation and Weight-Bearing Exercise: Human Study Protocol for a Randomized Controlled Trial
dc.typeJournal article
pubs.elements-id449206
pubs.organisational-groupOther
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