Osteoporosis is a disease characterized by loss of bone mineral density (BMD) and deteriorated bone microstructure, resulting in reduced bone strength and increased risk of fracture. Loss of BMD occurs from the third decade of life, but women experience an accelerated bone loss following menopause. We have previously shown that daily supplementation with the probiotic Lactobacillus reuteri for 12 months reduces bone loss in older women with low bone mass(1), but the underlying mechanism remains to be elucidated. Recent studies in mice have demonstrated that short-chain fatty acids (SCFAs) produced by the gut microbiota regulate bone mass via induction of regulatory T cells resulting in increased bone formation and decreased bone resorption. The primary aim of the OsteoPreP trial is to investigate if daily consumption of a probiotic supplement containing inulin (a prebiotic soluble fibre) twice daily for 12 months can prevent the rapid bone loss in early postmenopausal women. Secondary aims will focus on intestinal SCFA levels, gut microbiota composition, immune system modulation as well as musculoskeletal and metabolic function as potential mediators.
One hundred and sixty postmenopausal women (aged 40-65 years, 1 to 4 years since final menses) will be recruited from the community to participate in this single-site, double-blind, placebo-controlled trial. Participants will be randomized to receive the active supplement or placebo. The percentage change from baseline in BMD and bone microarchitecture at 12 months will be measured with high-resolution peripheral quantitative computed tomography. Secondary endpoints include stool SCFA levels, gut microbiome analysis by shotgun metagenomics, blood regulatory T cell numbers, blood glucose and glycaemic variability, cognition, ambulatory blood pressure, and muscle tissue function.
If long-term consumption of this probiotic supplement can protect against bone loss in postmenopausal women, this intervention can be used to effectively prevent osteoporosis and potentially associated musculoskeletal and metabolic conditions.