Fish Oil and Muscle Function

NCT ID: NCT01308957

Last Updated: 2014-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-12-31

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.

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Long chain omega-3 fatty acids

Group Type: EXPERIMENTAL

Omega-3 fatty acids

Intervention Type: DIETARY_SUPPLEMENT

4 grams per day for 24 weeks

Corn oil

Group Type: PLACEBO_COMPARATOR

corn oil

Intervention Type: DIETARY_SUPPLEMENT

4 grams per day for 24 weeks

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Omega-3 fatty acids

4 grams per day for 24 weeks

Intervention Type: DIETARY_SUPPLEMENT

corn oil

4 grams per day for 24 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Lovaza

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bettina Mittendorfer, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25994567 (View on PubMed)

Other Identifiers

201012999

Identifier Type: -

Identifier Source: org_study_id