OsteoPreP: Food Supplements for Postmenopausal Bone Health

Ki vehet részt

• Postmenopausal women, 40-65 years old
• Caucasian (due to significant differences in BMD and bone remodelling between ethnicities)
• At least one year since final menses
• Signed informed consent
• Up to date Covid 19 vaccination status
• Able to walk without the use of an aid
• Stated availability throughout the entire study period
• Mental capacity to understand and willingness to fulfil all the details of the protocol
• Residing in Melbourne, Victoria, Australia

Ki nem vehet részt

• Bariatric surgery
• 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)
• Antibiotics treatment 2 months prior to inclusion
• 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
• Recently diagnosed malignancy (within the last 5 years)
• HbA1c ≥6.5% at screening visit
• Diagnosis of osteoporosis
• T-score of -2.5 or less at the femoral neck or lumbar spine (L1-L4) on the DXA scan at screening visit
• Blood pressure at screening visit of systolic >180 mmHg and/or diastolic >120 mmHg
• Untreated hyperthyroidism
• Rheumatoid arthritis
• Use of teriparatide (current or during the last 3 years)
• Participation in other clinical intervention trials
• Unwilling to cease taking other probiotic or prebiotic supplements (current use)