Clinical trial NCT01308957: Fish Oil and Muscle Function
Official title: Omega-3 Fatty Acids, Muscle Mass and Muscle Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2011-03-04
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evaluate the effect of omega-3 fatty acids on muscle mass
timeFrame: Change from baseline in muscle mass at 24 weeks in older adults only
measure: Evaluate the effect of omega-3 fatty acids on physical function
timeFrame: Change from baseline in physical function at 24 weeks in older adults only
Secondary outcomes:
measure: Evaluate the effect of aging on muscle mass
timeFrame: During baseline testing in both young and older subjects
measure: Evaluate the effect of aging on physical function
timeFrame: During baseline testing in both young and older subjects
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Bettina Mittendorfer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.