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Fish Oil and Muscle Function

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3 fatty acids
corn oil
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Long chain omega-3 fatty acids

Corn oil

Young healthy controls

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 25, 2011
Last Updated
December 8, 2014
Sponsor
Washington University School of Medicine
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01308957
Brief Title
Fish Oil and Muscle Function
Official Title
Omega-3 Fatty Acids, Muscle Mass and Muscle Function
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Long chain omega-3 fatty acids
Arm Type
Experimental
Arm Title
Corn oil
Arm Type
Placebo Comparator
Arm Title
Young healthy controls
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acids
Other Intervention Name(s)
Lovaza
Intervention Description
4 grams per day for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
corn oil
Intervention Description
4 grams per day for 24 weeks
Primary Outcome Measure Information:
Title
Evaluate the effect of omega-3 fatty acids on muscle mass
Description
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.
Time Frame
Change from baseline in muscle mass at 24 weeks in older adults only
Title
Evaluate the effect of omega-3 fatty acids on physical function
Description
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.
Time Frame
Change from baseline in physical function at 24 weeks in older adults only
Secondary Outcome Measure Information:
Title
Evaluate the effect of aging on muscle mass
Description
We will measure total fat-free mass by duel X-ray absorptiometry, thigh muscle and intermuscular fat volumes by using magnetic resonance imaging.
Time Frame
During baseline testing in both young and older subjects
Title
Evaluate the effect of aging on physical function
Description
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.
Time Frame
During baseline testing in both young and older subjects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bettina Mittendorfer, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25994567
Citation
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.
Results Reference
derived

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Fish Oil and Muscle Function

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