A Randomized, Double-Blind, Placebo-Controlled, Clinical Food Trial of Probiotic/Prebiotic Medical Food for the Dietary Management of Age Related Bone Loss
This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination (synbiotic) on the skeleton in older women.
• Provide written informed consent
• Stated availability throughout entire study period and willingness to fulfill all details of the protocol
• Age 60 years and above
• DXA-BMD of the hip and spine (T-score) \> -2.5. Women with a BMD T score ≤ -2.5 (i.e. women with low BMD indicating osteoporosis) will also be considered if they have decided not to accept the standard of care with use of osteoporosis medications for the entire duration of their participation in the study.
• 25-hydroxy vitamin D ≥ 20 ng/mL
• Normal renal function (eGFR \>50 ml/min)
• Have chosen to not accept the standard of care with use of osteoporosis medications for the duration of the study.
• Willing to comply with protocol and report on compliance and side effects during study period.