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

  • STATUS
    Recruiting
  • days left to enroll
    63
  • participants needed
    300
  • sponsor
    Solarea Bio, Inc
Updated on 24 March 2022
body mass index
calcium
bone mineral density
menstrual period
osteopenia
Accepts healthy volunteers

Summary

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.

Details
Condition Osteopenia
Treatment Placebo, Medical Food SBD111
Clinical Study IdentifierNCT05009875
SponsorSolarea Bio, Inc
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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