Effects of 12-month probiotic supplementation on bone mineral density and bone turnover markers in early postmenopausal females: A double-blind randomized controlled trial
Abstract
Background: Early postmenopausal females experience rapid bone loss, and modulation of the gut-bone axis has been proposed as a preventive strategy. However, the role of probiotics relative to established lifestyle factors such as nutrition and physical activity remains unclear.
Objectives: To evaluate whether 12 mo of supplementation with a lactobacilli-based probiotic attenuates bone loss in early postmenopausal females.
Methods: In this double-blind, randomized, placebo-controlled trial, 114 females 1 to 8 y postmenopause were allocated to a daily probiotic (Lactiplantibacillus plantarum DSM15312, DSM15313, and Lacticaseibacillus paracasei DSM13434) or placebo. The primary outcome was change in distal tibia total volumetric bone mineral density (BMD) assessed by high-resolution peripheral quantitative computed tomography. Secondary outcomes included additional high-resolution peripheral quantitative computed tomography parameters, areal BMD by dual-energy X-ray absorptiometry, and circulating biomarkers. Intention-to-treat analyses were conducted using linear mixed-effects models, adjusted for baseline covariates; secondary outcomes were corrected for multiple comparisons.
Results: A total of 114 participants were randomly assigned, and all available data were included in the analyses. Baseline characteristics were broadly comparable. Over 12 mo, both groups experienced modest declines in bone density. The primary analysis showed a modest but statistically significant…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 114 participants or records.
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