ACTRN12621001171808招募中未知
OsteoPreP: The effect of probiotic supplementation on bone, muscle, and glucose metabolism in postmenopausal women: A randomised placebo-controlled trial
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 65 Years（—）
- 性别
- Female
入选标准
- •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
排除标准
- •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)
研究者
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