Synbiotic to Attenuate Resorption of the Skeleton

Eligibility Criteria

• 1. Provide 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 with use of osteoporosis medications for the entire duration of their participation in the study.
• 5. 25-hydroxy vitamin D ≥ 20 ng/mL
• 6. Normal renal function (eGFR \>50 ml/min)
• 7. Have chosen to not accept the standard of care with use of osteoporosis medications for the duration of the study.
• 8. Willing to comply with protocol and report on compliance and side effects during study period.
• 1. BMI greater than equal to 35 kg/m2.
• 2. Participants consuming dietary supplements (fish oil, probiotics/prebiotics, and fiber) in the prior month, and and unwilling to avoid these supplements for the duration of the study.
• 3. Known or suspected allergies to probiotics, gelatin, rice, edible fruit extract or berries.
• 4. We will exclude women using antibiotics in the past 3 months but those placed on an antibiotic after enrollment, will be retained.
• 5. History of drug and/or alcohol abuse at the time of enrolment.
• 6. Presence of any of the following:
• 1. History of other bone disorders (e.g. Paget's disease)
• 2. History of major low-trauma fragility fractures (hip, forearm, humerus, spine) since the age of 50 years
• 3. History of cancer other than skin cancer \<5 years in remission, autoimmune disease, immune problems such as AIDS, type 1 or 2 diabetes, gastrointestinal disorders (ulcerative colitis, inflammatory bowel disease)
• 4. History of colon resection, any disease that could interfere with the intestinal barrier function such as ulcerative colitis, irritable bowel syndrome or Crohn's disease
• 5. Women with untreated hyperparathyroidism
• 6. History of chronic antibiotic use
• 7. History of bariatric surgery
• 8. History of partial colectomy
• 9. History of problems with pancreas
• 10. History of history of chronic Hepatitis B or Hepatitis C, cirrhosis, fatty liver (nonalcoholic steatohepatitis; NASH) or chronic liver disease
• 11. History of problems with your heart valves, endocarditis, or previously had a valve replacement
• 12. Currently have problems with bone marrow such as myelodysplastic syndrome or anemia requiring transfusions
• 13. Women with spine abnormalities that would interfere with the assessment of BMD
• 14. Current smoking or use of nicotine products within the past 6-months
• 15. Major surgery or endoscopy within last 3 months
• 16. Coloscopy planned in the next 18-months and unwilling to reschedule it
• 17. Indwelling catheter, implanted hardware/prosthetic device or feeding tube
• 18. Any medical condition that could interfere with the conduct of the study
• 7. Treatment with calcitonin, estrogens, selective estrogen receptor modulators, progestins, anabolic steroids, or glucocorticoids in the past 6 months
• 8. Treatment with bisphosphonates in the past 3 yrs
• 9. Previous treatment with parathyroid hormone (PTH), abaloparatide, romosozumab or denosumab in the last year or current coumadin use.
• 10. Participation in other bone, diet, autoimmune, or GI related clinical trials in the last 6 months. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
• 11. Participants who plan on changing diet and/or exercise regime during trial participation.
• 12. Screening laboratory tests greater than upper normal limit (ULN) or less than lower normal limit (LLN):
• * 25-hydroxy vitamin D \<20 ng/mL
• * Renal dysfunction (eGFR ≤50 ml/min)
• 13. Seated blood pressure greater than equal to 160 mm Hg or seated diastolic BP greater than equal to 100mm Hg.
• 14. Short Blessed Test score \>10 or judged by the research staff as unable to follow the study protocol
• 15. Current treatment or previous with Glucagon-like peptide (GLP-1) agonists in the last one year.
• 16. Any other condition that in the opinion of the investigator or study clinician would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study.