Trials / Completed
CompletedNCT02722980
Efficacy of a Probiotic Product on Bone Mineral Density (BMD) in Healthy Women in Early Post-menopausal Phase
A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study Aiming to Evaluate the Efficacy on BMD and Safety of a Probiotic Product in a Population of Healthy Women in Early Post-menopausal Phase, During an Intervention Period of 12 Months
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 249 (actual)
- Sponsor
- Probi AB · Industry
- Sex
- Female
- Age
- 45 Years – 70 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Placebo | The intervention consists of capsules containing placebo. |
| DIETARY_SUPPLEMENT | : Probiotic capsules | The intervention consists of capsules containing probiotics. |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2018-01-01
- Completion
- 2018-01-01
- First posted
- 2016-03-30
- Last updated
- 2018-04-17
Locations
2 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT02722980. Inclusion in this directory is not an endorsement.