OsteopeniaNCT05009875
Food Trial Evaluating the Efficacy of SBD111 Versus Placebo for the Clinical Dietary Management of the Metabolic Processes of Osteopenia
A study testing Medical Food SBD111 in people with Osteopenia, run by Solarea Bio, Inc at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopenia
- What is being tested?
- Medical Food SBD111
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Dec 2021to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Osteopenia
- Being tested
- Medical Food SBD111, Placebo
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Food SBD111Other
Two capsules administered twice daily with morning and evening meals for 52 weeks
PlaceboOther
Two capsules administered twice daily with morning and evening meals for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| SBD111 | Experimental | Not described Receives: Other: Medical Food SBD111 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change in Bone Mineral Density (BMD) from baseline to 52 weeks
Secondary outcomes (24)
Change in Bone Mineral Density (BMD) at the femoral neck from baseline to 52 weeks
Change in Bone Mineral Density (BMD) at the femoral neck following an administration period of 52 weeks and measured by DXA
Measured: Change in Bone Mineral Density (BMD) from baseline to 52 weeks
Change in Bone Mineral Density (BMD) at the hip from baseline to 52 weeks
Change in Bone Mineral Density (BMD) at the hip following an administration period of 52 weeks and measured by DXA
Measured: Change in Bone Mineral Density (BMD) from baseline to 52 weeks
Change in volumetric BMD (vBMD) measured by quantitative computed tomography (QCT) at the lumbar spine from baseline to 52 weeks
Change in volumetric BMD (vBMD) measured by quantitative computed tomography (QCT) at the lumbar spine (L1-L2 or L1-L4) from baseline to 52 weeks
Measured: Change in volumetric BMD (vBMD) from baseline to 52 weeks
Change in circulating C-Reactive Protein (CRP) from baseline to 52 weeks
Change in circulating C-Reactive Protein (CRP) from baseline to 52 weeks
Measured: Change from baseline to 52 weeks
Change in circulating Interleukin-17 (IL-17) from baseline to 52 weeks
Change in circulating Interleukin-17 (IL-17) from baseline to 52 weeks
Measured: Change from baseline to 52 weeks
Change in circulating Tumor Necrosis Factor (TNF) from baseline to 52 weeks
Change in circulating Tumor Necrosis Factor (TNF) from baseline to 52 weeks
Measured: Change from baseline to 52 weeks
Change in circulating Interleukin-4 (IL-4) from baseline to 52 weeks
Change in circulating Interleukin-4 (IL-4) from baseline to 52 weeks
Measured: Change from baseline to 52 weeks
Change in circulating receptor activator of nuclear factor kappa beta ligand (RANKL) from baseline to 52 weeks
Change in circulating receptor activator of nuclear factor kappa beta ligand (RANKL) from baseline to 52 weeks
Measured: Change from baseline to 52 weeks
Change in circulating Interferon gamma (IFNy) from baseline to 52 weeks
Change in circulating Interferon gamma (IFNy) from baseline to 52 weeks
Measured: Change from baseline to 52 weeks
Change in circulating C-terminal telopeptide of type 1 collagen (CTX) from baseline to 52 weeks
Change in circulating C-terminal telopeptide of type 1 collagen (CTX) from baseline to 52 weeks
Measured: Change from baseline to 52 weeks
Change in circulating Procollagen 1 Intact N-Terminal Propeptide (P1NP) from baseline to 52 weeks
Change in circulating Procollagen 1 Intact N-Terminal Propeptide (P1NP) from baseline to 52 weeks
Measured: Change from baseline to 52 weeks
Safety as assessed by incidence of adverse events and serious adverse events
Safety as assessed by incidence of adverse events and serious adverse events from baseline to 52 weeks
Measured: Change from baseline to 52 weeks
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ) from baseline to 1-week
Measured: Change from baseline to 1-week
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ) from baseline to 2-weeks
Measured: Change from baseline to 2-weeks
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ) from baseline to 3-weeks
Measured: Change from baseline to 3-weeks
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ) from baseline to 4-weeks
Measured: Change from baseline to 4-weeks
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ) from baseline to 3-months
Measured: Change from baseline to 3-months
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ) from baseline to 6-months
Measured: Change from baseline to 6-months
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ) from baseline to 9-months
Measured: Change from baseline to 9-months
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ) from baseline to 12-months
Measured: Change from baseline to 12-months
Change from baseline in the global Menopause Rating Scale (MRS)
Change from baseline in the global Menopause Rating Scale (MRS) from baseline to 3-months
Measured: Change from baseline to 3-months
Change from baseline in the global Menopause Rating Scale (MRS)
Change from baseline in the global Menopause Rating Scale (MRS) from baseline to 6-months
Measured: Change from baseline to 6-months
Change from baseline in the global Menopause Rating Scale (MRS)
Change from baseline in the global Menopause Rating Scale (MRS) from baseline to 9-months
Measured: Change from baseline to 9-months
Change from baseline in the global Menopause Rating Scale (MRS)
Change from baseline in the global Menopause Rating Scale (MRS) from baseline to 12-months
Measured: Change from baseline to 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start15 Dec 2021
- Primary completion17 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solarea Bio, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009875
- Sponsor's protocol ID
- SOL-SYNBIOTIC-2021
- Status last verified
- Sep 2024
- First submitted
- 10 Aug 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Trial Evaluating the Efficacy of SBD111 Versus Placebo for the Clinical Dietary Management of the Metabolic Processes of Osteopenia
- ClinicalTrials.gov ID
- NCT05009875
- Acronym / sponsor ID
- SOL-SYNBIOTIC-2021
- Conditions
- Osteopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Solarea Bio, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBD111 | Experimental | Other: Medical Food SBD111 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Food SBD111Two capsules administered twice daily with morning and evening meals for 52 weeks | Other | SBD111 |
| PlaceboTwo capsules administered twice daily with morning and evening meals for 52 weeks | Other | Placebo |
Primary outcome
Change in Lumbar Spine Bone Mineral Density (BMD) from baseline to 52 weeks
Time frame: Change in 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
24 secondary outcomes
Change in Bone Mineral Density (BMD) at the femoral neck from baseline to 52 weeks
Time frame: Change in Bone Mineral Density (BMD) from baseline to 52 weeks
Change in Bone Mineral Density (BMD) at the hip from baseline to 52 weeks
Time frame: Change in Bone Mineral Density (BMD) from baseline to 52 weeks
Change in volumetric BMD (vBMD) measured by quantitative computed tomography (QCT) at the lumbar spine from baseline to 52 weeks
Time frame: Change in volumetric BMD (vBMD) from baseline to 52 weeks
Change in circulating C-Reactive Protein (CRP) from baseline to 52 weeks
Time frame: Change from baseline to 52 weeks
Change in circulating Interleukin-17 (IL-17) from baseline to 52 weeks
Time frame: Change from baseline to 52 weeks
Change in circulating Tumor Necrosis Factor (TNF) from baseline to 52 weeks
Time frame: Change from baseline to 52 weeks
Change in circulating Interleukin-4 (IL-4) from baseline to 52 weeks
Time frame: Change from baseline to 52 weeks
Change in circulating receptor activator of nuclear factor kappa beta ligand (RANKL) from baseline to 52 weeks
Time frame: Change from baseline to 52 weeks
Change in circulating Interferon gamma (IFNy) from baseline to 52 weeks
Time frame: Change from baseline to 52 weeks
Change in circulating C-terminal telopeptide of type 1 collagen (CTX) from baseline to 52 weeks
Time frame: Change from baseline to 52 weeks
Change in circulating Procollagen 1 Intact N-Terminal Propeptide (P1NP) from baseline to 52 weeks
Time frame: Change from baseline to 52 weeks
Safety as assessed by incidence of adverse events and serious adverse events
Time frame: Change from baseline to 52 weeks
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Time frame: Change from baseline to 1-week
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Time frame: Change from baseline to 2-weeks
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Time frame: Change from baseline to 3-weeks
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Time frame: Change from baseline to 4-weeks
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Time frame: Change from baseline to 3-months
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Time frame: Change from baseline to 6-months
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Time frame: Change from baseline to 9-months
Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
Time frame: Change from baseline to 12-months
Change from baseline in the global Menopause Rating Scale (MRS)
Time frame: Change from baseline to 3-months
Change from baseline in the global Menopause Rating Scale (MRS)
Time frame: Change from baseline to 6-months
Change from baseline in the global Menopause Rating Scale (MRS)
Time frame: Change from baseline to 9-months
Change from baseline in the global Menopause Rating Scale (MRS)
Time frame: Change from baseline to 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Food SBD111 in people with Osteopenia, run by Solarea Bio, Inc at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lumbar Spine Bone Mineral Density (BMD) from baseline to 52 weeks (time frame: Change in Bone Mineral Density (BMD) from baseline to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.