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

NCT05009875 | Completed

• 1 other identifier: SOL-SYNBIOTIC-2021
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Change in Bone Mineral Density (BMD) at the femoral neck from baseline to 52 weeks

  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) 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) 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 from baseline to 52 weeks

Other Outcomes (3)

• Change in gut microbiome composition and function from baseline

  Change from baseline to 6-months

• Change in gut microbiome composition and function from baseline

  Change from baseline to 52-weeks

• Change in body composition measured by DXA

  Change from baseline to 52-weeks

Study Arms (2)

SBD111

EXPERIMENTAL

Other: Medical Food SBD111

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Medical Food SBD111 OTHER

Two capsules administered twice daily with morning and evening meals for 52 weeks

SBD111

Placebo OTHER

Two capsules administered twice daily with morning and evening meals for 52 weeks

Placebo

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Solarea Bio, Inc: lead

Study Sites (1)

RDC Clinical

Newstead, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 18, 2021
• Study Start: December 15, 2021
• Primary Completion: July 17, 2024
• Study Completion: August 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

AU (1)