The Effect of Lactobacillus Reuteri ATCC PTA 6475 on Volumetric Bone Mineral Density in Patients With Osteopenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Total tibia volumetric bone mineral density
研究概览
简要总结
Lactobacillus reuteri (L. reuteri) has been widely studied in clinical trials and has probiotic, health-promoting effects in both adults and children, and is safe for human consumption. Animal models indicate that treatment with L. reuteri has positive effects on bone metabolism and bone density. In other animal models of diabetes and the metabolic syndrome, positive effects on blood glucose and weight have been reported. The present double-blind, placebo-controlled, randomized study is designed to investigate if dietary supplementation with L. reuteri twice daily for 12 months has any effect on bone density, body composition, inflammation, or metabolic and endocrine markers in elderly women with osteopenia.
详细描述
The role of the gut microbes for human health has gained considerable interest in recent years. Lactobacillus reuteri (L.reuteri) is a naturally occurring bacterial species in the human gut. L. reuteri has been widely studied in clinical trials of adults and children and treatment with L. reuteri is safe and is associated with health-promoting effects in humans. In animal models, L. reuteri has anti-inflammatory effects and in ovariectomized mice supplementation with L. reuteri partly prevented the bone loss induced by estrogen deficiency. Furthermore, both bone density and bone formation increased in male mice in another mice model. In mice with medically induced diabetes mellitus, L. reuteri reduced blood glucose and in a mouse model mimicking the metabolic syndrome, L. reuteri prevented diet-induced obesity. The present study is a double-blind, placebo-controlled, randomized, study in 90 elderly women with osteopenia recruited from the population. These women will be treated with L. reuteri or placebo orally twice daily for 12 months. The effects on bone will be investigated with dual energy x-ray absorptiometry, high-resolution peripheral quantitative computed tomography, and bone turnover markers. Hormones and markers of inflammation and metabolism will be followed as well as changes in the gut microbiota composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 80 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •bone mineral density T-score less than -1 but more than -2.5 in the total hip or femoral neck or lumbar spine (L1-L4) by dual energy x-ray absorptiometry
- •signed informed consent
- •stated availability throughout the entire study period
- •mental ability to understand and willingness to fulfill all the details of the protocol
排除标准
- •untreated hyperthyroidism
- •rheumatoid arthritis
- •diagnosed with disease causing secondary osteoporosis within the last year, including primary hyperparathyroidism, chronic obstructive pulmonary disease, inflammatory bowel disease, celiac disease, or diabetes
- •recently diagnosed malignancy (within the last 5 years)
- •per oral corticosteroid use
- •use of antiresorptive therapy, including systemic hormone replacement therapy, bisphosphonates, strontium ran elate
- •use of teriparatide (current or during the last 3 years)
- •participation in other clinical interventional trials
- •use of antibiotics within 2 months preceding the inclusion
研究组 & 干预措施
Placebo
Placebo product identical to the active product (L. reuteri) in taste and appearance but without the active component, orally twice daily, for 12 months.
干预措施: Placebo (Dietary Supplement)
L. reuteri
Lactobacillus reuteri (L. reuteri) ATCC PTA 6475 at a dose of 5 000 000 000 CFU as a powder in a stick-pack, orally twice daily (morning and evening) yielding a total daily dose of 10 000 000 000 CFU per day, for 12 months.
干预措施: L. reuteri (Dietary Supplement)
结局指标
主要结局
Total tibia volumetric bone mineral density
时间窗: 12 months
Change in percent in total tibia volumetric bone mineral density compared to placebo group after 1 year of dietary supplementation with L. reuteri
次要结局
- Trabecular volumetric bone mineral density(12 months)
- Bone material strength index(12 months)
- Change in gut microbiota composition(3-12 months)
- Interleukin-17(3-12 months)
- Bone-specific alkaline phosphatase(3-12 months)
- Osteocalcin(3-12 months)
- Triglycerides(3-12 months)
- Cortical volumetric bone mineral density(12 months)
- Areal bone mineral density(12 months)
- Ultrasensitive C-reactive protein(3-12 months)
- Receptor activator of nuclear factor kappa B ligand (RANK-ligand)(3-12 months)
- Low density lipoprotein (LDL)(3-12 months)
- Cortical porosity(12 months)
- Tumor-necrosis factor-alpha(3-12 months)
- Tartrate-resistent alkaline phosphatase 5b(3-12 months)
- Cross-linked N-terminal telopeptide(3-12 months)
- Receptor activator of nuclear factor kappa B (RANK)(3-12 months)
- Leptin(3-12 months)
- Cortical thickness(12 months)
- Blood pressure(12 months)
- Haemoglobin A1C(3-12 months)
- Cholesterol(3-12 months)
- Adiponectin(3-12 months)
- Interleukin-10(3-12 months)
- Blood glucose(3-12 months)
- Apolipoprotein B (ApoB)(3-12 months)
- High density lipoprotein (HDL)(3-12 months)
- Estradiol(3-12 months)
- Lean mass(12 months)
- Apolipoprotein A1 (ApoA1)(3-12 months)
- Oxytocin(3-12 months)
- Testosterone(3-12 months)
- Fat mass(12 months)
研究者
Mattias Lorentzon
Professor, Specialist physician
Sahlgrenska University Hospital, Sweden