Synbiotic to Attenuate Resorption of the Skeleton

Inclusion Criteria:

• 1. Provided written informed consent.
• 2. Stated availability throughout entire study period and willingness to fulfill alldetails 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 theyhave decided not to accept the standard of care use of osteoporosis medications forthe entire duration of their participation in the study.
• 5. Women with a history of major low-trauma fragility fractures (hip, forearm,humerus, spine) since the age of 50 years will be considered if they are notcurrently using osteoporosis medications, or if they have decided not to accept thestandard of care osteoporosis medications, even if diagnosed with osteoporosisduring the screening procedure.
• 6. Serum 25-hydroxyvitamin D ≥ 20 ng/mL.
• 7. Normal renal function (eGFR >50 ml/min).
• 8. Have chosen to not accept the standard of care use of osteoporosis medicationsfor the duration of the study.
• 9. Willing to comply with protocol and report on compliance and side effects duringthe study period.

Exclusion Criteria:

• 1. BMI greater than 40 kg/m2.
• 2. Participants consuming dietary supplements (fish oil, probiotics/prebiotics, andfiber) in the prior month, and unwilling to avoid these supplements for the durationof the study.
• 3. Participants using osmotic laxatives >1 per week and unwilling to avoid use forthe duration of the study.
• 4. Known or suspected allergies to probiotics, rice, edible fruit extract orberries.
• 5. Antibiotic use in the past 3 months. Participants placed on an antibiotic afterenrollment will be retained.
• 6. History of drug and/or alcohol abuse at the time of enrolment.
• 7. Presence of any of the following:

• a. History of other bone disorders (e.g. Paget's disease).

• b. History of moderate to severe scoliosis.

• c. History of cancer other than skin cancer <5 years in remission, autoimmunedisease, immune problems such as AIDS, type 1 or 2 diabetes.

• d. History of colon resection, any disease that could interfere with the intestinalbarrier function such as ulcerative colitis, irritable bowel syndrome or Crohn'sdisease or any chronic bowel condition.

• e. Women with untreated hyperparathyroidism.

• f. History of chronic antibiotic use.

• g. History of bariatric surgery.

• h. History of partial colectomy.

• i. History of pancreatic disease.

• j. History of active hepatitis B, hepatitis C, cirrhosis, metabolicdysfunction-associated steatotitc liver disease (MASLD), fatty liver or chronicliver disease.

• k. Current bone marrow disorders such as myelodysplastic syndrome or anemiarequiring transfusions.

• l. Abnormalities of the spine determined by the study physician to interfere withthe assessment of bone mineral density.

• m. Current smoking or use of nicotine products within the past 6 months.

• n. Current use of marijuana and unwilling to abstain during the study period.

• o. Major abdominal surgery within the last 3 months.

• p. Colonoscopy within the last 1 month.

• q. Colonoscopy planned in the next 18 months and unwilling to reschedule it.

• r. Indwelling catheter, implanted hardware/prosthetic device or feeding tube.

• s. Any medical condition that could interfere with the conduct of the study.

• 8. Treatment with calcitonin, estrogens, selective estrogen receptor modulators,progestins, anabolic steroids, or glucocorticoids in the past 6 months.
• 9. Treatment with bisphosphonates in the past 3 years.
• 10. Previous treatment with parathyroid hormone (PTH), abaloparatide, romosozumab ordenosumab in the last year or current coumadin use.
• 11. Current or previous treatment with glucagon-like peptide (GLP-1) receptoragonists in the last one year.
• 12. Participation in other bone, diet, autoimmune, or GI related clinical trials inthe last 6 months. If the subject has been in a recent experimental trial, thesemust have been completed not less than 60 days prior to this study.
• 13. Participants who plan on changing diet and/or exercise regime during trialparticipation.
• 14. Screening laboratory tests greater than upper normal limit (ULN) or less thanlower normal limit (LLN):

• Serum 25-hydroxyvitamin D <20 ng/mL

• Renal dysfunction (eGFR ≤50 ml/min)

• 15. Seated blood pressure greater than equal to 160 mm Hg or seated diastolic bloodpressure greater than equal to 100mm Hg.
• 16. Short Blessed Test score >10 or judged by the research staff as unable to followthe study protocol.
• 17. Any other condition that in the opinion of the investigator or study clinicianwould jeopardize the safety or rights of the volunteer participating in the study orwould make it unlikely the volunteer could complete the study.