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

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 Overview

• Status: Active, not recruiting
• Conditions: Osteopenia
• Intervention / Treatment: Other: Medical Food SBD111; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 286
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Newstead, Queensland, Australia, 4006
      • RDC Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Two capsules administered twice daily with morning and evening meals for 52 weeks
Experimental: SBD111	Other: Medical Food SBD111; Two capsules administered twice daily with morning and evening meals for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Solarea Bio, Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: SOL-SYNBIOTIC-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No