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

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 -2.5 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 35 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, osteoporosis, etc.)
• Women who have had cancer and were treated with radiation therapy, anti-estrogen therapy, hormonal therapy, or aromatase inhibitors
• Any history of bone or colon cancer
• Autoimmune disorders (rheumatoid arthritis, Hashimoto's disease, Graves' disease, ect), uncontrolled 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 hip joint replacement
• 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 (if participant is placed on an antibiotic after enrolment in the study, will be subject to a per protocol analysis)