METHODS: Seventy-four elderly (60-85 years) participants will be randomized in a double-blind, placebo-controlled fashion to either an intervention or control group. The intervention group (n = 37) will receive oral synbiotic formulation daily for 16 weeks. The control group (n = 37) will receive placebo. Assessments of physical performance (including Short Physical Performance Battery, handgrip strength and timed up-and-go tests) and muscle ultrasonography will be performed at 4 time points (baseline and weeks 8, 16 and 20). Likewise, body composition via bioelectric impedance analysis and blood and stool samples will be collected at each time point. Dual-energy X-ray absorptiometry will be performed at baseline and week 16. The primary outcomes will be between-group changes in physical performance from baseline to 16 weeks. Secondary outcomes include changes in body composition, muscle mass and architecture, fecal microbiota composition and diversity, and fecal and plasma metabolomics.
CONCLUSIONS: Gut-modulating supplements appear to be effective in modifying gut microbiota composition in healthy older adults. However, it is unclear whether these changes translate into functional and/or health improvements. In the present study, we will investigate the effects of a synbiotic formulation on measures of physical performance, strength and muscle health in healthy older populations.
BACKGROUND: This study was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622000652774) in May 2022.
方法:74名老年(60-85岁)参与者将被随机双盲,对干预组或对照组进行安慰剂对照。干预组(n=37)将每天接受口服合生元制剂,持续16周。对照组(n=37)将接受安慰剂。物理性能评估(包括短物理性能电池,将在4个时间点(基线和第8周,第16周和第20周)进行手握力量和定时上行测试)和肌肉超声检查。同样,通过生物电阻抗分析和血液和粪便样本将在每个时间点收集身体成分。将在基线和第16周进行双能X射线吸收测定。主要结果将是从基线到16周的身体表现的组间变化。次要结果包括身体成分的变化,肌肉质量和结构,粪便微生物群组成和多样性,粪便和血浆代谢组学。
结论:肠道调节补充剂似乎可有效改变健康老年人的肠道菌群组成。然而,目前尚不清楚这些变化是否转化为功能和/或健康改善.在本研究中,我们将研究合生元配方对身体性能测量的影响,健康老年人群的力量和肌肉健康。
背景:这项研究于2022年5月在澳大利亚新西兰临床试验注册中心(ACTRN12622000652774)进行了前瞻性注册。