OsteoPreP: food supplements for postmenopausal bone health

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 160

Inclusion Criteria

•Postmenopausal women
•Caucasian (due to significant differences in BMD and bone remodeling between ethnicities)
•Between 1 and 4 years since final menses
•Signed informed consent
•Stated availability throughout the entire study period
•Mental ability to understand and willingness to fulfill all the details of the protocol
• 'Up to date' vaccination status
• Able to walk without the use of an aid

Exclusion Criteria

•Diagnosis of osteoporosis
•Low trauma fracture after 50 years of age
•T-score of -2.5 or less at the femoral neck or lumbar spine (L1-L4) on the DXA scan at screening visit
•HbA1c equal to or greater than 6.5% at screening visit
•Blood pressure at screening visit of systolic >180 mmHg and/or diastolic >120 mmHg
•Untreated hyperthyroidism
•Rheumatoid arthritis
•Diagnosed with a disease causing secondary osteoporosis or malabsorption: chronic obstructive pulmonary disease, inflammatory bowel disease, celiac disease, type 1/type 2 diabetes, or chronic liver disease
•Bariatric surgery
•Recently diagnosed malignancy (within the last 5 years)
•Current or recent oral corticosteroid use (any dose within the last 3 months, or 5mg of Prednisolone (or equivalent) or a higher daily dose for 14 days or more 3-12 months prior to screening)
•Use of antiresorptive therapy, including systemic hormone replacement therapy, bisphosphonates, strontium ranelate (current or during the last 3 years)
•Use of teriparatide (current or during the last 3 years)
•Participation in other clinical intervention trials
•Antibiotics treatment 2 months prior to inclusion
•Unwilling to cease taking other probiotic or prebiotic supplements (current use)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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