A Randomized, Double-Blind, Placebo-Controlled, Clinical Food Trial of Probiotic/Prebiotic Medical Food for the Dietary Management of Age Related Bone Loss
Hebrew SeniorLife
Summary
This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination ("synbiotic") on the skeleton in older women.
Description
There are currently no consistent guidelines on how middle aged and older adults can maintain healthy bone mass as they age. Hence, there is an unmet need for safe and effective dietary interventions for the metabolic processes underlying bone loss. The objective of this project, is to test the efficacy of a probiotic/prebiotic combination or synbiotic i.e. Solarea Bio defined microbial assemblage 111 (SBD111) medical food on the skeleton of older women. Aim 1: To determine the effect of 18 months of daily intake of SBD111 medical food on the primary outcome of lumbar spine dual energy x-ray…
Eligibility
- Age range
- 60+ years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * 1\. Provided written informed consent. * 2\. Stated availability throughout entire study period and willingness to fulfill all details of the protocol. * 3\. Age 60 years and above. * 4\. 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 use of osteoporosis medications for the entire duration of their participation in the study. * 5\. Women with a history of major low-trauma fragility fractures (hip, forearm, hume…
Interventions
- OtherSBD111 medical food
SBD111 medical food is a defined microbial assemblage (DMA) consisting of oligofructose and dried berry powder (prebiotics), a Pseudomonas fluorescens, a Lactobacillus brevis, a Leuconostoc mesenteroides, a Lactobacillus plantarum, and a Pichia kudriavzevii (yeast).
- OtherPlacebo
Placebo
Location
- Hebrew SeniorLifeRoslindale, Massachusetts