Omega-3 Fatty Acids, Muscle Mass and Muscle Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Evaluate the effect of omega-3 fatty acids on physical function
研究概览
简要总结
The purpose of this study is to examine the effect of omega-3 fatty acid supplementation on changes in muscle mass, muscular strength and physical function.
详细描述
Loss of muscle mass is a normal consequence of aging in many older adults, worsened by chronic illness, poor appetite and diet, and reduced physical activity. The ensuing decline in physical function is a major cause of frailty, disability and death. Treatments that can reverse or reduce the age-associated loss of muscle mass are therefore much needed. Evidence is emerging that consumption of fish or fish oil derived long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) may be important for maintenance of muscle mass and physical function throughout the life-span. However, the effect of LCn-3PUFA supplementation on muscle mass, muscle strength and overall physical function is not known. The goal of this study therefore is to determine the effect of LCn-3PUFA supplementation on muscle mass, muscle strength and physical function in older adults.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-obese (i.e., BMI less than 35 kg/m2)
- •Between 18 to 45 or between 60 and 85 y old
- •Subjects who are sedentary (<1 h of exercise/week)
排除标准
- •Subjects with evidence of significant organ system dysfunction (e.g. diabetes, severe cardiovascular disease, hyperlipidemia, cirrhosis, hypogonadism, uncontrolled hypo- or hyperthyroidism; uncontrolled hypertension)
- •Subjects with metal implants
- •Subjects with iron storage disease,
- •Subjects with severe ambulatory impairments,
- •Individuals with cancer or cancer that has been in remission for <5 years,
- •Individuals with dementia,
- •Individuals who smoke,
- •Subjects who are taking medications known to affect muscle (e.g., steroids),
- •Subjects who receive anticoagulant therapy.
- •Subjects taking medications to control certain medical conditions (e.g., hypertension) will be included if the drug regimen has been stable for at least 6 months before entering the study and is not expected to change during the study.
- •Subjects with allergies to sea food,
- •Subjects who regularly consume fish oil or consume >2 servings of fish with a high LCn-3PUFA content (e.g. salmon, mackerel, sardines, etc) per week.
- •Physical performance test score less than 17 out of 36.
结局指标
主要结局
Evaluate the effect of omega-3 fatty acids on physical function
时间窗: Change from baseline in physical function at 24 weeks in older adults only
We will evaluate muscle strength by assessing one-repetition maximum strength of upper- and lower-body skeletal muscles, grip strength and isometric and isokinetic force development. We will assess overall physical function using the physical performance tests, which evaluates the ability to perform usual daily activities such as climbing a flight of stairs, walking 50 feet and putting on and removing a coat. These measurements will also be assessed at week 12 in a subset of subjects but the data will not be used as a primary outcome measure.
Evaluate the effect of omega-3 fatty acids on muscle mass
时间窗: Change from baseline in muscle mass at 24 weeks in older adults only
We will measure thigh muscle volume by using magnetic resonance imaging. These measurements will also be assessed at week 12 in a subset of subjects but the data will not be used as a primary outcome measure.
次要结局
- Evaluate the effect of aging on muscle mass(During baseline testing in both young and older subjects)
- Evaluate the effect of aging on physical function(During baseline testing in both young and older subjects)