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

April 10, 2023 updated by: Solarea Bio, Inc
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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Newstead, Queensland, Australia, 4006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 -2.49 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 32.5 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, etc.)
  • History of cancer other than skin cancer, autoimmune disorders (rheumatoid arthritis, hashimoto's, graves' disease, ect) 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 any joint replacement (hip, knee, etc.)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Change in 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solarea Bio, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

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)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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