Fish Oil and Muscle Function

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Washington University School of Medicine
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01308957
First received: February 25, 2011
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Sarcopenia
Dietary Supplement: Omega-3 fatty acids
Dietary Supplement: corn oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acids, Muscle Mass and Muscle Function

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Evaluate the effect of aging on muscle mass [ Time Frame: During baseline testing in both young and older subjects ] [ Designated as safety issue: No ]
    We will measure total fat-free mass by duel X-ray absorptiometry, thigh muscle and intermuscular fat volumes by using magnetic resonance imaging.

  • Evaluate the effect of aging on physical function [ Time Frame: During baseline testing in both young and older subjects ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 90
Study Start Date: June 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Long chain omega-3 fatty acids Dietary Supplement: Omega-3 fatty acids
4 grams per day for 24 weeks
Other Name: Lovaza
Placebo Comparator: Corn oil Dietary Supplement: corn oil
4 grams per day for 24 weeks
Other Name: corn oil
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308957

Contacts
Contact: Lynda Bowers, M.S.ed 314-362-0590 sjullian@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Lynda Bowers, MSed    314-362-0590    lbowers@dom.wustl.edu   
Principal Investigator: Bettina Mittendorfer, PhD         
Sponsors and Collaborators
Washington University School of Medicine
GlaxoSmithKline
Investigators
Principal Investigator: Bettina Mittendorfer, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01308957     History of Changes
Other Study ID Numbers: 201012999
Study First Received: February 25, 2011
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014