Fish Oil and Muscle Function

Sarcopenia Clinical Trial

Official title:

Omega-3 Fatty Acids, Muscle Mass and Muscle Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308957
• Other study ID #: 201012999
• Status: Completed
• Phase: N/A
• First received: February 25, 2011
• Last updated: December 8, 2014
• Start date: June 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• Omega-3 fatty acids
4 grams per day for 24 weeks
• corn oil
4 grams per day for 24 weeks

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No