Synbiotic to Attenuate Resorption of the Skeleton

Exclusion Criteria38

• \. BMI greater than 40 kg/m2.
• \. Participants consuming dietary supplements (fish oil, probiotics/prebiotics, and fiber) in the prior month, and unwilling to avoid these supplements for the duration of the study.
• \. Participants using osmotic laxatives \>1 per week and unwilling to avoid use for the duration of the study.
• \. Known or suspected allergies to probiotics, rice, edible fruit extract or berries.
• \. Antibiotic use in the past 3 months. Participants placed on an antibiotic after enrollment will be retained.
• \. History of drug and/or alcohol abuse at the time of enrolment.
• \. 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, autoimmune disease, immune problems such as AIDS, type 1 or 2 diabetes.
• d. 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 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, metabolic dysfunction-associated steatotitc liver disease (MASLD), fatty liver or chronic liver disease.
• k. Current bone marrow disorders such as myelodysplastic syndrome or anemia requiring transfusions.
• l. Abnormalities of the spine determined by the study physician to interfere with the 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.
• \. Treatment with calcitonin, estrogens, selective estrogen receptor modulators, progestins, anabolic steroids, or glucocorticoids in the past 6 months.
• \. Treatment with bisphosphonates in the past 3 years.
• \. Previous treatment with parathyroid hormone (PTH), abaloparatide, romosozumab or denosumab in the last year or current coumadin use.
• \. Current or previous treatment with glucagon-like peptide (GLP-1) receptor agonists in the last one year.
• \. 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.
• \. Participants who plan on changing diet and/or exercise regime during trial participation.
• \. Screening laboratory tests greater than upper normal limit (ULN) or less than lower normal limit (LLN):
• Serum 25-hydroxyvitamin D \<20 ng/mL
• Renal dysfunction (eGFR ≤50 ml/min)
• \. Seated blood pressure greater than equal to 160 mm Hg or seated diastolic blood pressure greater than equal to 100mm Hg.
• \. Short Blessed Test score \>10 or judged by the research staff as unable to follow the study protocol.
• \. 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.