Phase
Condition
Inflammation
Osteoporosis
Aging
Treatment
SBD111 medical food
Placebo
Clinical Study ID
Ages > 60 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provide written informed consent
Stated availability throughout entire study period and willingness to fulfill alldetails 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 havedecided not to accept the standard of care with use of osteoporosis medications forthe 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 medicationsfor the duration of the study.
Willing to comply with protocol and report on compliance and side effects duringstudy period.
Exclusion
Exclusion Criteria:
BMI greater than equal to 35 kg/m2.
Participants consuming dietary supplements (fish oil, probiotics/prebiotics, andfiber) in the prior month, and and unwilling to avoid these supplements for theduration of the study.
Known or suspected allergies to probiotics, gelatin, rice, edible fruit extract orberries.
We will exclude women using antibiotics in the past 3 months but those placed on anantibiotic after enrollment, will be retained.
History of drug and/or alcohol abuse at the time of enrolment.
Presence of any of the following:
History of other bone disorders (e.g. Paget's disease)
History of major low-trauma fragility fractures (hip, forearm, humerus, spine)since the age of 50 years
History of cancer other than skin cancer <5 years in remission, autoimmunedisease, immune problems such as AIDS, type 1 or 2 diabetes, gastrointestinaldisorders (ulcerative colitis, inflammatory bowel disease)
History of colon resection, any disease that could interfere with theintestinal barrier function such as ulcerative colitis, irritable bowelsyndrome or Crohn's disease
Women with untreated hyperparathyroidism
History of chronic antibiotic use
History of bariatric surgery
History of partial colectomy
History of problems with pancreas
History of history of chronic Hepatitis B or Hepatitis C, cirrhosis, fattyliver (nonalcoholic steatohepatitis; NASH) or chronic liver disease
History of problems with your heart valves, endocarditis, or previously had avalve replacement
Currently have problems with bone marrow such as myelodysplastic syndrome oranemia requiring transfusions
Women with spine abnormalities that would interfere with the assessment of BMD
Current smoking or use of nicotine products within the past 6-months
Major surgery or endoscopy within last 3 months
Coloscopy planned in the next 18-months and unwilling to reschedule it
Indwelling catheter, implanted hardware/prosthetic device or feeding tube
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 yrs
Previous treatment with parathyroid hormone (PTH), abaloparatide, romosozumab ordenosumab in the last year or current coumadin use.
Participation in other bone, diet, autoimmune, or GI related clinical trials in thelast 6 months. If the subject has been in a recent experimental trial, these musthave been completed not less than 60 days prior to this study.
Participants who plan on changing diet and/or exercise regime during trialparticipation.
Screening laboratory tests greater than upper normal limit (ULN) or less than lowernormal limit (LLN):
25-hydroxy vitamin D <20 ng/mL
Renal dysfunction (eGFR ≤50 ml/min)
Seated blood pressure greater than equal to 160 mm Hg or seated diastolic BP greaterthan equal to 100mm Hg.
Short Blessed Test score >10 or judged by the research staff as unable to follow thestudy protocol
Current treatment or previous with Glucagon-like peptide (GLP-1) agonists in thelast one year.
Any other condition that in the opinion of the investigator or study clinician wouldjeopardize the safety or rights of the volunteer participating in the study or wouldmake it unlikely the volunteer could complete the study.
Study Design
Study Description
Connect with a study center
Hebrew SeniorLife
Roslindale, Massachusetts 02131
United StatesActive - Recruiting
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