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 tofulfill all details of the protocol

• In early postmenopause (at least 1 year but a maximum of 6 years since the lastmenstruation)

• 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 ofgreater than -2.5 at the lumbar spine (L1-L4), femoral neck, and total hip but nosite 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, diastolicblood 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, osteogenesisimperfecta, osteopetrosis, osteoporosis, etc.)

• Women who have had cancer and were treated with radiation therapy, anti-estrogentherapy, 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), kidneydisease or dysfunction or any other medical condition that could interfere with theconduct 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, selectiveestrogen receptor modulators (SERMs), tibolone, progestins, anabolic steroids, ordaily 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 ordenosumab

• 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 theintestinal barrier function

• Participation in other bone, diet, autoimmune, or gastrointestinal related clinicaltrials in the last 6 months

• Desire and/or plans on changing current diet and/or exercise regime during theparticipation of this trial

• Pregnancy or lactation

• Consumption of dietary supplements (probiotics, prebiotics) in the month prior to orduring study (if participant is willing to stop taking these for 1-month, they canbe enrolled after a 1-month washout period)

• Consumption of antibiotics in the past 2 months (if participant is placed on anantibiotic after enrolment in the study, will be subject to a per protocol analysis)