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

NCT05009875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

OTHER

Medical Food SBD111

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Solarea Bio, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2024-07-17
Completion
2024-08-01

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05009875 on ClinicalTrials.gov