Ilesanmi-Oyelere Bolaji Lilian, Roy Nicole C, Kruger Marlena C
College of Health, Massey University, Palmerston North, New Zealand.
Department of Human Nutrition, University of Otago, Dunedin, New Zealand.
JMIR Res Protoc. 2021 Oct 26;10(10):e30131. doi: 10.2196/30131.
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.
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.
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.
Recruitment of participants will begin in September 2021, and the anticipated completion date is June 2022.
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.
Australian New Zealand Clinical Trials Registry ACTRN12620000998943p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380336&isClinicalTrial=False.
有强有力的证据表明，益生元和益生菌可调节肠道微生物群，减轻炎症，从而有可能改善骨骼健康状况。同样，从机制方面的证据来看，低强度或高强度负重运动可改善身体成分，进而增加骨质疏松症和骨关节炎患者的骨矿物质密度。
本研究旨在调查补充合生制剂（益生菌+益生元）、运动干预或两者结合对绝经后女性肠道微生物群、炎症和骨生物标志物的影响。
将招募160名来自新西兰的绝经后女性，并将她们随机分为四种干预措施或治疗组之一，为期12周：对照组、补充合生制剂、运动干预或补充合生制剂并运动。主要结局指标是基线和第12周时的骨与关节生物标志物，而肠道微生物群谱和炎症细胞因子测量将作为基线和第12周时的次要结局指标。基线数据和运动史将用于评估、分配和分层参与者的治疗措施。
参与者招募将于2021年9月开始，预计完成日期为2022年6月。
据我们所知，这将是第一项分析补充合生制剂和运动干预对绝经后女性影响的随机对照试验。根据所得结果，合生制剂补充剂与运动相结合可能是一种管理和/或改善绝经后女性身体成分和骨骼健康的非侵入性方法。
澳大利亚新西兰临床试验注册中心ACTRN12620000998943p；https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380336&isClinicalTrial=False。
