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
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Condition or disease | Intervention/treatment | Phase |
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Sarcopenia | Dietary Supplement: Omega-3 fatty acids Dietary Supplement: corn oil | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 77 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Omega-3 Fatty Acids, Muscle Mass and Muscle Function |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
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Experimental: Long chain omega-3 fatty acids |
Dietary Supplement: Omega-3 fatty acids
4 grams per day for 24 weeks
Other Name: Lovaza |
Placebo Comparator: Corn oil |
Dietary Supplement: corn oil
4 grams per day for 24 weeks |
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.
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- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308957
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: | Bettina Mittendorfer, PhD | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT01308957 |
Other Study ID Numbers: |
201012999 |
First Posted: | March 4, 2011 Key Record Dates |
Last Update Posted: | December 10, 2014 |
Last Verified: | December 2014 |
Sarcopenia Muscular Atrophy Neuromuscular Manifestations Neurologic Manifestations |
Nervous System Diseases Atrophy Pathological Conditions, Anatomical |