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

May 10, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
286

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Bone Mineral Density (BMD) at the femoral neck 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 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
Time Frame: Change in Bone Mineral Density (BMD) 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
Time Frame: Change in volumetric BMD (vBMD) 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
Time Frame: Change 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
Time Frame: Change 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
Time Frame: Change 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
Time Frame: Change 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
Time Frame: Change 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
Time Frame: Change 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
Time Frame: Change 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
Time Frame: Change 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
Time Frame: Change from baseline to 52 weeks
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)
Time Frame: Change from baseline to 1-week
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)
Time Frame: Change from baseline to 2-weeks
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)
Time Frame: Change from baseline to 3-weeks
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)
Time Frame: Change from baseline to 4-weeks
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)
Time Frame: Change from baseline to 3-months
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)
Time Frame: Change from baseline to 6-months
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)
Time Frame: Change from baseline to 9-months
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)
Time Frame: Change from baseline to 12-months
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)
Time Frame: Change from baseline to 3-months
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)
Time Frame: Change from baseline to 6-months
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)
Time Frame: Change from baseline to 9-months
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)
Time Frame: Change from baseline to 12-months
Change from baseline in the global Menopause Rating Scale (MRS) from baseline to 12-months
Change from baseline to 12-months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in gut microbiome composition and function from baseline
Time Frame: Change from baseline to 6-months
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
Time Frame: Change from baseline to 52-weeks
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
Time Frame: Change from baseline to 52-weeks
Change in body composition measured by DXA from baseline to 52-weeks
Change from baseline to 52-weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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