Fish Oil and Muscle Function

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Omega-3 fatty acids; Dietary supplement: corn oil

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Corn oil	Dietary supplement: corn oil; 4 grams per day for 24 weeks
Experimental: Long chain omega-3 fatty acids	Dietary supplement: Omega-3 fatty acids; 4 grams per day for 24 weeks; Other Names: Lovaza
No Intervention: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: GlaxoSmithKline

Publications and helpful links

General Publications

• Smith GI, Julliand S, Reeds DN, Sinacore DR, Klein S, Mittendorfer B. Fish oil-derived n-3 PUFA therapy increases muscle mass and function in healthy older adults. Am J Clin Nutr. 2015 Jul;102(1):115-22. doi: 10.3945/ajcn.114.105833. Epub 2015 May 20.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: March 2, 2011
• First Posted (Estimate): March 4, 2011

Study Record Updates

• Last Update Posted (Estimate): December 10, 2014
• Last Update Submitted That Met QC Criteria: December 8, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 201012999