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Completed

NCT Number: NCT01308957

Fish Oil 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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega-3 fatty acids

Dietary Supplement

4 grams per day for 24 weeks

Other names: Lovaza

corn oil

Dietary Supplement

4 grams per day for 24 weeks

Primary outcomes

  1. Evaluate the effect of omega-3 fatty acids on muscle mass

    Time frame: 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.

  2. Evaluate the effect of omega-3 fatty acids on physical function

    Time frame: 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.

Secondary outcomes

  1. Evaluate the effect of aging on muscle mass

    Time frame: During baseline testing in both young and older subjects

    We will measure total fat-free mass by duel X-ray absorptiometry, thigh muscle and intermuscular fat volumes by using magnetic resonance imaging.

  2. Evaluate the effect of aging on physical function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Omega-3 Fatty Acids, Muscle Mass and Muscle Function

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 4, 2011
Registry last updated
Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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