Osteopenia
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTPlacebo
The intervention consists of capsules containing placebo.
DIETARY_SUPPLEMENT: Probiotic capsules
The intervention consists of capsules containing probiotics.
Sponsors
Probi AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
For inclusion in the study, subjects must fulfil the following criteria: 1. Willing and able to give written informed consent for participation in the study. 2. Healthy women in early post-menopausal phase (at least two \[2\] years but a maximum of 12 years since the last menstruation and at least one \[1\] year since the last intake of hormone replacement therapy). 3. BMI ≥ 18 and ≤ 30 at screening. 4. BMD T-score in the lumbar spine (L1-L4) \> -2.5, as measured by DXA. 5. Commitment not to use any products that may influence the study outcome in the opinion of the Investigator. 6. Ability to understand and comply with the requirements of the study, as judged by the Investigator.
Exclusion criteria
Subjects must not enter the study if any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in BMD at lumbar spine following an intervention period of 12 months and measured by DXA. | Change in BMD from baseline to 12 months |
Countries
Sweden
Outcome results
None listed