Fish Oil and Muscle Function

NCT01308957 | Completed DMC

• 1 other identifier: 201012999
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Evaluate the effect of aging on muscle mass

  During baseline testing in both young and older subjects

• Evaluate the effect of aging on physical function

  During baseline testing in both young and older subjects

Study Arms (3)

Long chain omega-3 fatty acids

EXPERIMENTAL

Dietary Supplement: Omega-3 fatty acids

Corn oil

PLACEBO COMPARATOR

Dietary Supplement: corn oil

Young healthy controls

NO INTERVENTION

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.

Interventions

Omega-3 fatty acids DIETARY_SUPPLEMENT

4 grams per day for 24 weeks

Also known as: Lovaza

Long chain omega-3 fatty acids

corn oil DIETARY_SUPPLEMENT

4 grams per day for 24 weeks

Corn oil

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 25994567 DERIVED

MeSH Terms

Conditions

Sarcopenia

Interventions

Fatty Acids, Omega-3; Omacor; Corn Oil

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Bettina Mittendorfer, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: March 4, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 10, 2014

Record last verified: 2014-12

Locations

US (1)