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

Solarea Bio

Status

Completed

Conditions

Osteopenia

Treatments

Other: Placebo

Other: Medical Food SBD111

Study type

Interventional

Funder types

Industry

Identifiers

NCT05009875

SOL-SYNBIOTIC-2021

Details and patient eligibility

About

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.

Enrollment

286 patients

Sex

Female

Ages

45 to 70 years old

Volunteers

Accepts Healthy Volunteers

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)