Effects of Omega-3 Fatty Acids on Bone and Frailty
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Bone turnover markers
研究概览
简要总结
The purpose of this study is to examine the effects of essential fatty acid (EFA) supplementation on bone metabolism and frailty in postmenopausal women. The overall hypothesis is that EFA supplementation, via its immunoregulatory and anti-inflammatory activity, will decrease bone turnover, decrease prostaglandins and cytokines associated with bone metabolism and frailty, and change physical outcome measures associated with frailty in postmenopausal women with low bone mass and frailty.
详细描述
Osteoporosis is a bone thinning disease that results in fractures that occur with minimal trauma. The direct health care costs related to osteoporosis are estimated to be $14 billion per year, comparable to costs in heart failure and asthma. Frailty, or poor physiologic reserve to deal with stressors, is estimated to be 7% in the general population over age 65. The frailty syndrome is characterized by sarcopenia or muscle loss, inflammation, low estrogen, growth hormone and testosterone levels, poor nutrition and disability, and is associated with an increased risk of falls and fracture. Omega-3 fatty acids found in fish oil (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) have been shown to decrease markers of inflammation (cytokines) and decrease death due to heart disease. A number of studies in animals suggest that fish oil (EPA and DHA) supplementation inhibits bone break down, increases calcium absorbed from the diet and enhances calcium in bone. Few studies have assessed the role of n-6 and n-3 fatty acids in the diet in bone disease in humans. As far as we know, no study has evaluated the role of n-3 fatty acids in the frailty syndrome.
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
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women over 65 years old
- •Spine or hip bone density T score less than -1
- •Hand grip strength 2 standard deviations below weight adjusted norms
- •Able to travel to the clinical sites for follow-up visits
排除标准
- •Any disease that may affect bone metabolism, (i.e Paget's disease, primary hyperparathyroidism)
- •Cancer of any kind (except basal or squamous cell of skin) in past 5 years.
- •Use of calcitonin, calcitriol, heparin, phenytoin, phenobarbital, and estrogen in the past 6 months
- •Use of bisphosphonates, long-term corticosteroids (more than 6 months), methotrexate, or fluoride at any time
- •Current use of any medication or herbs with anticoagulant or antiplatelet activity, tetracycline, and magnesium or zinc supplementation
- •Estimated creatinine clearance less than 50 ml/min
- •History of chronic liver disease or evidence of liver disease on screening
- •History of hip fracture or known vertebral fracture within the past year
- •Untreated hypertension or a history of clotting disorders
- •History of allergy to fish or fish oil
结局指标
主要结局
Bone turnover markers
时间窗: baseline, 3 and 6 months
次要结局
- Bone Mineral Density(baseline, 3 and 6 months)
- Physical performance measures(baseline, 3 and 6 months)
- Blood pressure and lab work, including lipids, cytokines, prostaglandins, lymphocyte characterization, and EPA/DHA in blood and plasma(baseline, 3 and 6 months)
- Cognitive status, mood and depression(baseline, 3 and 6 months)