Abstract
BackgroundThere 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.ObjectiveThis 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.MethodsA 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.ResultsRecruitment of participants will begin in September 2021, and the anticipated completion date is June 2022.ConclusionsTo 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 RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12620000998943p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380336&isClinicalTrial=False
Highlights
IntroductionThe global incidence of postmenopausal osteoporosis is increasing [1,2]
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
Postmenopausal osteoporosis is characterized by increased low-grade inflammation that contributes to low bone mass and degradation of bone mineral content, resulting in postmenopausal bone loss [3,4,5]
Summary
The global incidence of postmenopausal osteoporosis is increasing [1,2]. Postmenopausal osteoporosis is characterized by increased low-grade inflammation that contributes to low bone mass and degradation of bone mineral content, resulting in postmenopausal bone loss [3,4,5]. The long-term use of HRT as an anabolic treatment and high doses of estrogen may not reduce the incidence of bone fracture [7] and are associated with long-term side effects. There is strong evidence suggesting that prebiotics and probiotics regulate gut microbiota, reducing inflammation and thereby potentially improving bone health status. Mechanistic evidence suggests that either low-impact or high-impact weight-bearing exercises improve body composition and increase bone mineral density in individuals with osteoporosis and osteoarthritis
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