Fish Oil and Muscle Function
2014年12月8日 更新者：Washington University School of Medicine
Omega-3 Fatty Acids, Muscle Mass and Muscle Function
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
77
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Missouri
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Saint Louis、Missouri、美国、63110
- Washington University School of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：玉米油
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4 grams per day for 24 weeks
|
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实验性的：Long chain omega-3 fatty acids
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4 grams per day for 24 weeks
其他名称：
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无干预：Young healthy controls
Young subjects' muscle mass and physical function will be evaluated once (i.e., during baseline testing only).
The data in young subjects will be used to determine the magnitude of the aging-induced decline in muscle mass and physical function in the older subjects prior to starting the interventions.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluate the effect of omega-3 fatty acids on muscle mass
大体时间：Change from baseline in muscle mass at 24 weeks in older adults only
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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.
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Change from baseline in muscle mass at 24 weeks in older adults only
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Evaluate the effect of omega-3 fatty acids on physical function
大体时间：Change from baseline in physical function at 24 weeks in older adults only
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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.
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Change from baseline in physical function at 24 weeks in older adults only
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluate the effect of aging on muscle mass
大体时间：During baseline testing in both young and older subjects
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We will measure total fat-free mass by duel X-ray absorptiometry, thigh muscle and intermuscular fat volumes by using magnetic resonance imaging.
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During baseline testing in both young and older subjects
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Evaluate the effect of aging on physical function
大体时间：During baseline testing in both young and older subjects
|
We will evaluate muscle strength by assessing one-repetition maximum strength of upper- and lower-body skeletal muscles, grip strength, thigh isometric and isokinetic force development and time-to-peak force development during thigh isokinetic exercises.
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.
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During baseline testing in both young and older subjects
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年6月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2011年2月25日
首先提交符合 QC 标准的
2011年3月2日
首次发布 (估计)
2011年3月4日
研究记录更新
最后更新发布 (估计)
2014年12月10日
上次提交的符合 QC 标准的更新
2014年12月8日
最后验证
2014年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.