Fish Oil and Muscle Function

This study is currently recruiting participants.
Verified April 2013 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 11, 2013
Last verified: April 2013

February 25, 2011
April 11, 2013
June 2011
March 2014   (final data collection date for primary outcome measure)
  • Evaluate the effect of omega-3 fatty acids on muscle mass [ Time Frame: Change from baseline in muscle mass at 12 and 24 weeks ] [ Designated as safety issue: No ]
    We will measure total body muscle mass by dual energy X-ray absorptiometry, thigh muscle volume by using magnetic resonance imaging and muscle morphology (e.g., muscle fiber size) by standard histological methods.
  • Evaluate the effect of omega-3 fatty acids on physical function [ Time Frame: Change from baseline in physical function at 12 and 24 weeks ] [ 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.
Same as current
Complete list of historical versions of study NCT01308957 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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.

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 frail, older adults.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Sarcopenia
  • Dietary Supplement: Omega-3 fatty acids
    4 grams per day for 24 weeks
    Other Name: Lovaza
  • Dietary Supplement: corn oil
    4 grams per day for 24 weeks
    Other Name: corn oil
  • Experimental: Long chain omega-3 fatty acids
    Intervention: Dietary Supplement: Omega-3 fatty acids
  • Placebo Comparator: Corn oil
    Intervention: Dietary Supplement: corn oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-obese (i.e., BMI less than 30 kg/m2)
  • 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.
Both
60 Years to 85 Years
Yes
Contact: Rachel Burrows, BA 314-747-2627 rburrows@dom.wustl.edu
United States
 
NCT01308957
201012999
Yes
Washington University School of Medicine
Washington University School of Medicine
GlaxoSmithKline
Principal Investigator: Bettina Mittendorfer, PhD Washington University in St. Louis
Washington University School of Medicine
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP