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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBD111 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Food SBD111 | Other | Two capsules administered twice daily with morning and evening meals for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change in Bone Mineral Density (BMD) from baseline to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gut microbiome composition and function from baseline | Change in gut microbiome composition and function from baseline to 6-months | Change from baseline to 6-months |
| Change in gut microbiome composition and function from baseline |
Inclusion Criteria:
Exclusion Criteria:
The presence of any of the following criteria will exclude the participant from participating in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical | Newstead | Queensland | 4006 | Australia |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Other | Two capsules administered twice daily with morning and evening meals for 52 weeks |
|
Change in Bone Mineral Density (BMD) at the hip following an administration period of 52 weeks and measured by DXA |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Change from baseline to 12-months |
Change in gut microbiome composition and function from baseline to 12-months
| Change from baseline to 52-weeks |
| Change in body composition measured by DXA | Change in body composition measured by DXA from baseline to 52-weeks | Change from baseline to 52-weeks |