Turbić Alisa, Vandenput Liesbeth, Gandham Anoohya, Lorentzon Mattias
Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC 3000, Australia.
Sahlgrenska Osteoporosis Centre, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, University of Gothenburg, 41345 Gothenburg, Sweden.
Nutrients. 2024 Dec 6;16(23):4219. doi: 10.3390/nu16234219.
BACKGROUND/OBJECTIVES: Correction of decreased diversity of the gut microbiome, which is characteristic of menopause, by supplementation with a synbiotic may attenuate or prevent dysbiosis processes and preserve bone mass. We describe the rationale and design of the OsteoPreP trial aimed at evaluating the effects of 12 months of supplementation with a synbiotic on bone and metabolic health in postmenopausal Caucasian women.
This is a randomized, double-blinded, placebo-controlled trial among 160 Caucasian, postmenopausal women with no current diagnosis of osteoporosis or supplementation with pro- or prebiotics, and no medical treatment affecting bone turnover. Dual-energy X-ray absorptiometry scans will be conducted at screening to confirm absence of osteoporosis. The primary outcome is the relative change (%) in total bone mineral density of the distal tibia at 12 months post-treatment between the active and placebo groups, as determined via high-resolution peripheral quantitative computed tomography. Secondary outcomes are the effects on immune system modulation and cognition, gut microbiota composition, and musculoskeletal and metabolic functions, with particular emphasis on blood glucose regulation.
The trial will inform on the efficacy and safety of a synbiotic containing both aerobic and anerobic bacterial strains and a prebiotic fiber on reduction in bone loss and on indices of blood glucose regulation. This trial may pave the way for an exciting field of translational research and be the underpinnings of the prevention strategy of osteoporosis and the management of metabolic dysfunction in postmenopausal women. The trial is registered with clinicaltrials.gov (NCT05348694).
背景/目的：补充合生元可纠正肠道微生物群多样性降低（这是更年期的特征），可能减轻或预防生态失调过程并维持骨量。我们描述了OsteoPreP试验的基本原理和设计，该试验旨在评估补充合生元12个月对绝经后白人女性骨骼和代谢健康的影响。
这是一项针对160名白人绝经后女性的随机、双盲、安慰剂对照试验，这些女性目前未被诊断为骨质疏松症，未补充益生菌或益生元，且没有影响骨转换的药物治疗。在筛查时将进行双能X线吸收测定扫描以确认无骨质疏松症。主要结局是通过高分辨率外周定量计算机断层扫描确定的治疗后12个月时活性组和安慰剂组之间胫骨远端总骨密度的相对变化（%）。次要结局是对免疫系统调节和认知、肠道微生物群组成以及肌肉骨骼和代谢功能的影响，特别强调血糖调节。
该试验将为含有需氧和厌氧细菌菌株以及益生元纤维的合生元在减少骨质流失和血糖调节指标方面的疗效和安全性提供信息。该试验可能为一个令人兴奋的转化研究领域铺平道路，并成为绝经后女性骨质疏松症预防策略和代谢功能障碍管理的基础。该试验已在clinicaltrials.gov（NCT05348694）注册。
