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Efficacy of a Probiotic Product on Bone Mineral Density (BMD) in Healthy Women in Early Post-menopausal Phase

NCT02722980 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2018-04-17

No results posted yet for this study

Summary

The aim of the current study is to evaluate the efficacy of a probiotic product on bone mineral density (BMD) in healthy early post-menopausal women, compared to placebo. The primary endpoint is to assess changes of BMD at lumbar spine after an intervention period of 12 months. Changes in BMD at the femoral neck (hip) will also be measured as well as changes in bone turnover markers during the period of 12 months.

Conditions

  • Osteopenia

Interventions

DIETARY_SUPPLEMENT

Placebo

The intervention consists of capsules containing placebo.

DIETARY_SUPPLEMENT

: Probiotic capsules

The intervention consists of capsules containing probiotics.

Sponsors & Collaborators

  • Probi AB

    lead INDUSTRY

Principal Investigators

  • Dan Curiac · Gothenburg

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Sweden

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 NCT02722980 on ClinicalTrials.gov