Food Trial Evaluating the Efficacy of SBD111 Versus Placebo for the Clinical Dietary Management of the Metabolic Processes of Osteopenia
Primary Purpose
Osteopenia
Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Medical Food SBD111
Placebo
Sponsored by
About this trial
This is an interventional other trial for Osteopenia
Eligibility Criteria
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
Sites / Locations
- RDC ClinicalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SBD111
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05009875
Brief Title
Food Trial Evaluating the Efficacy of SBD111 Versus Placebo for the Clinical Dietary Management of the Metabolic Processes of Osteopenia
Official Title
Food Trial Evaluating the Efficacy of SBD111 Versus Placebo for the Clinical Dietary Management of the Metabolic Processes of Osteopenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solarea Bio, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SBD111
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Medical Food SBD111
Intervention Description
Two capsules administered twice daily with morning and evening meals for 52 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Two capsules administered twice daily with morning and evening meals for 52 weeks
Primary Outcome Measure Information:
Title
Change in Lumbar Spine Bone Mineral Density (BMD) from baseline to 52 weeks
Description
Change in Bone Mineral Density (BMD) at lumbar spine following an administration period of 52 weeks and measured by DXA
Time Frame
Change in Bone Mineral Density (BMD) from baseline to 52 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Schott, PhD
Phone
585-704-8069
Email
eschott@solareabio.com
Facility Information:
Facility Name
RDC Clinical
City
Newstead
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Rao
Phone
61-731-024-486
Email
amanda@rdcglobal.com.au
12. IPD Sharing Statement
Learn more about this trial
Food Trial Evaluating the Efficacy of SBD111 Versus Placebo for the Clinical Dietary Management of the Metabolic Processes of Osteopenia
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