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Fish Oil and Muscle Function

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ClinicalTrials.gov Identifier: NCT01308957
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : December 10, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE February 25, 2011
First Posted Date  ICMJE March 4, 2011
Last Update Posted Date December 10, 2014
Study Start Date  ICMJE June 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2011)
  • Evaluate the effect of omega-3 fatty acids on muscle mass [ Time Frame: Change from baseline in muscle mass at 12 and 24 weeks ]
    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 ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fish Oil and Muscle Function
Official Title  ICMJE Omega-3 Fatty Acids, Muscle Mass and Muscle Function
Brief Summary 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Sarcopenia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Long chain omega-3 fatty acids
    Intervention: Dietary Supplement: Omega-3 fatty acids
  • Placebo Comparator: Corn oil
    Intervention: Dietary Supplement: 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2014)
77
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2011)
60
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01308957
Other Study ID Numbers  ICMJE 201012999
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Washington University School of Medicine
Original Responsible Party Dr Bettina Mittendorfer, Washington University School of Medicine
Current Study Sponsor  ICMJE Washington University School of Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Bettina Mittendorfer, PhD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date December 2014

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