Food Trial Evaluating the Efficacy of SBD111 Versus Placebo for the Clinical Dietary Management of the Metabolic Processes of Osteopenia

Study Overview
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Brief Summary
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The aim of the trial is to determine if the SYNBIOTIC (prebiotic and probiotic), provided twice daily (capsule) will help support skeletal health in otherwise healthy postmenopausal women in the early years postmenopause (1-6 years post last menstruation) over a 12-month period.

Official Title
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Food Trial Evaluating the Efficacy of SBD111 Versus Placebo for the Clinical Dietary Management of the Metabolic Processes of Osteopenia

Conditions
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Osteopenia

Intervention / Treatment
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* Other: Medical Food SBD111
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Stated availability throughout entire study period (12 months) and willingness to fulfill all details of the protocol In early postmenopause (at least 1 year but a maximum of 6 years since the last menstruation) At least 6-months since the last intake of hormone replacement therapy Dual energy X-ray absorptiometry (DXA)-derived Bone Mineral Density (BMD) T-score of greater than -2.49 at the lumbar spine (L1-L4), femoral neck, and total hip but no site with BMD ≤ -2.5 Body Mass Index between 18.5 and 32.5 kg/m2 Normal levels of serum calcium (<11mg/dL) Normal cardiovascular parameters (systolic blood pressure ≤ 155 mm Hg, diastolic blood pressure ≤ 95 mm Hg) healthy and medication controlled Exclusion Criteria: The presence of any of the following criteria will exclude the participant from participating in the study: History of other bone disorders (eg. Paget's disease, or osteomalacia, osteogenesis imperfecta, osteopetrosis, etc.) History of cancer other than skin cancer, autoimmune disorders (rheumatoid arthritis, hashimoto's, graves' disease, ect) type 2 diabetes, gastrointestinal disorders (ulcerative colitis, Crohn's disease, inflammatory bowel disease, irritable bowel syndrome), kidney disease or dysfunction or any other medical condition that could interfere with the conduct of the study. History of chronic antibiotic use History of bariatric surgery History of partial colectomy Women with spine abnormalities that would prohibit assessment of BMD Women who have undergone any joint replacement (hip, knee, etc.) Women who have undergone a partial hysterectomy Women with untreated hyperparathyroidism Women previously treated with calcitonin, estrogens, estrogen derivatives, selective estrogen receptor modulators (SERMs), tibolone, progestins, anabolic steroids, or daily glucocorticoids in the past 6 months Women treated with bisphosphonates or strontium in the past 5 years Women previously treated with PTH, PTH analogs, gallium nitrate, romosozumab or denosumab Per-oral use of corticosteroids Smoking or use of nicotine products within the past 6-months Any disease, that by the investigator's judgement, could interfere with the intestinal barrier function Participation in other bone, diet, autoimmune, or gastrointestinal related clinical trials in the last 6 months Desire and/or plans on changing current diet and/or exercise regime during the participation of this trial Pregnancy or lactation Consumption of dietary supplements (probiotics, prebiotics) in the month prior to or during study If participant is willing to stop taking these for 1-month, they can be enrolled after a 1-month washout period Consumption of antibiotics in the past 2 months

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBD111<br> | Other: Medical Food SBD111<br>* Two capsules administered twice daily with morning and evening meals for 52 weeks<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Two capsules administered twice daily with morning and evening meals for 52 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lumbar Spine Bone Mineral Density (BMD) from baseline to 52 weeks | Change in Bone Mineral Density (BMD) at lumbar spine following an administration period of 52 weeks and measured by DXA | Change in Bone Mineral Density (BMD) from baseline to 52 weeks |