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

Osteopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05009875
• Other study ID #: SOL-SYNBIOTIC-2021
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Solarea Bio, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 286
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia

Intervention

Other:
• Medical Food SBD111
Two capsules administered twice daily with morning and evening meals for 52 weeks
• Placebo
Two capsules administered twice daily with morning and evening meals for 52 weeks

Locations

Country	Name	City	State
Australia	RDC Clinical	Newstead	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Solarea Bio, Inc

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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