Clinical trial NCT05009875: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Lead sponsor: Solarea Bio, Inc
Sponsor class: INDUSTRY
First posted: 2021-08-18
Enrollment: 286
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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 -2.5 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)

Primary outcomes:
measure: Change in Lumbar Spine Bone Mineral Density (BMD) from baseline to 52 weeks
timeFrame: Change in Bone Mineral Density (BMD) from baseline to 52 weeks
Secondary outcomes:
measure: Change in Bone Mineral Density (BMD) at the femoral neck from baseline to 52 weeks
timeFrame: Change in Bone Mineral Density (BMD) from baseline to 52 weeks
measure: Change in Bone Mineral Density (BMD) at the hip from baseline to 52 weeks
timeFrame: Change in Bone Mineral Density (BMD) from baseline to 52 weeks
measure: Change in volumetric BMD (vBMD) measured by quantitative computed tomography (QCT) at the lumbar spine from baseline to 52 weeks
timeFrame: Change in volumetric BMD (vBMD) from baseline to 52 weeks
measure: Change in circulating C-Reactive Protein (CRP) from baseline to 52 weeks
timeFrame: Change from baseline to 52 weeks
measure: Change in circulating Interleukin-17 (IL-17) from baseline to 52 weeks
timeFrame: Change from baseline to 52 weeks
measure: Change in circulating Tumor Necrosis Factor (TNF) from baseline to 52 weeks
timeFrame: Change from baseline to 52 weeks
measure: Change in circulating Interleukin-4 (IL-4) from baseline to 52 weeks
timeFrame: Change from baseline to 52 weeks
measure: Change in circulating receptor activator of nuclear factor kappa beta ligand (RANKL) from baseline to 52 weeks
timeFrame: Change from baseline to 52 weeks
measure: Change in circulating Interferon gamma (IFNy) from baseline to 52 weeks
timeFrame: Change from baseline to 52 weeks
measure: Change in circulating C-terminal telopeptide of type 1 collagen (CTX) from baseline to 52 weeks
timeFrame: Change from baseline to 52 weeks
measure: Change in circulating Procollagen 1 Intact N-Terminal Propeptide (P1NP) from baseline to 52 weeks
timeFrame: Change from baseline to 52 weeks
measure: Safety as assessed by incidence of adverse events and serious adverse events
timeFrame: Change from baseline to 52 weeks
measure: Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
timeFrame: Change from baseline to 1-week
measure: Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
timeFrame: Change from baseline to 2-weeks
measure: Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
timeFrame: Change from baseline to 3-weeks
measure: Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
timeFrame: Change from baseline to 4-weeks
measure: Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
timeFrame: Change from baseline to 3-months
measure: Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
timeFrame: Change from baseline to 6-months
measure: Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
timeFrame: Change from baseline to 9-months
measure: Gastrointestinal tolerability as measured by Gastrointestinal Tolerability Questionnaire (GITQ)
timeFrame: Change from baseline to 12-months
measure: Change from baseline in the global Menopause Rating Scale (MRS)
timeFrame: Change from baseline to 3-months
measure: Change from baseline in the global Menopause Rating Scale (MRS)
timeFrame: Change from baseline to 6-months
measure: Change from baseline in the global Menopause Rating Scale (MRS)
timeFrame: Change from baseline to 9-months
measure: Change from baseline in the global Menopause Rating Scale (MRS)
timeFrame: Change from baseline to 12-months
Other outcomes:
measure: Change in gut microbiome composition and function from baseline
timeFrame: Change from baseline to 6-months
measure: Change in gut microbiome composition and function from baseline
timeFrame: Change from baseline to 52-weeks
measure: Change in body composition measured by DXA
timeFrame: Change from baseline to 52-weeks
Locations:
city: Newstead
country: Australia
facility: RDC Clinical
state: Queensland
Study officials:
References: