Fish Oil and Muscle Function

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Omega-3 Fatty Acids, Muscle Mass and Muscle Function

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Omega-3 fatty acids
* Dietary Supplement: corn oil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long chain omega-3 fatty acids<br> | Dietary Supplement: Omega-3 fatty acids<br>* 4 grams per day for 24 weeks<br>* Other names: Lovaza;|
| Placebo Comparator: Corn oil<br> | Dietary Supplement: corn oil<br>* 4 grams per day for 24 weeks<br>|
| No Intervention: Young healthy controls<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of omega-3 fatty acids on muscle mass | 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. | Change from baseline in muscle mass at 24 weeks in older adults only | 
| Evaluate the effect of omega-3 fatty acids on physical function | 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. | Change from baseline in physical function at 24 weeks in older adults only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of aging on muscle mass | We will measure total fat-free mass by duel X-ray absorptiometry, thigh muscle and intermuscular fat volumes by using magnetic resonance imaging. | During baseline testing in both young and older subjects | 
| Evaluate the effect of aging on physical function | 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. | During baseline testing in both young and older subjects |