Omega-3 Fatty Acids and Muscle Protein Synthesis

This study has been completed.
Sponsor:
Collaborators:
Longer Life Foundation
American Federation for Aging Research
Reliant Pharmaceuticals
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00794079
First received: November 18, 2008
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

The purpose of this study is to determine whether omega-3 fatty acid supplementation influences muscle protein synthesis rates in young and older adults.


Condition Intervention
Healthy
Dietary Supplement: omega-3 fatty acids
Dietary Supplement: corn oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Omega-3 Fatty Acids and Muscle Protein Synthesis

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Evaluate the effect of omega-3 fatty acid supplementation on skeletal muscle protein synthesis rates both in the basal, postabsorptive state and in response to infusion of insulin and amino acids in young and older adults [ Time Frame: Measurements taken prior to and following 8 weeks of supplementation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the effect of omega-3 fatty acid supplementation on anabolic signaling pathways in skeletal muscle [ Time Frame: Measurements taken prior to and following 8 weeks of supplementation ] [ Designated as safety issue: No ]
  • Evaluate the effect of omega-3 fatty acid supplementation on inflammatory cytokines in the systemic circulation and inflammatory signaling pathways in skeletal muscle [ Time Frame: Measurements taken prior to and following 8 weeks of supplementation ] [ Designated as safety issue: No ]
  • Compare muscle protein synthesis rates between men and women in the basal, postabsorptive state and in response to insulin and amino acid infusion [ Time Frame: prior to supplementation only ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: June 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
omega-3 fatty acids
Dietary Supplement: omega-3 fatty acids
4 grams per day for 8 weeks
Other Name: Lovaza
Placebo Comparator: B
corn oil
Dietary Supplement: corn oil
4 grams per day for 8 weeks
Other Name: corn oil

Detailed Description:

Loss of muscle mass is a normal consequence of aging. The decline in muscle mass is estimated to be 0.2-0.5% per year from 60 years old onwards in healthy subjects with the decline worsened by chronic illness, poor appetite and diet, and reduced physical activity in the elderly. Increased morbidity is demonstrable with as little as a 5% loss of muscle mass - therefore, treatments that can prevent or slow the progression of muscle loss with aging are much desired.

A major cause for loss of muscle mass in advanced age appears to be an impaired ability to stimulate the synthesis of muscle protein in response to increased levels of amino acids (the building blocks of proteins) and insulin as occurs after eating because of low-grade inflammation and insulin resistance in muscle of old persons. We propose that long-chain omega-3 polyunsaturated fatty acids (fish oil) slow the loss of muscle mass because fish oil has anti-inflammatory properties and increases the sensitivity of muscle protein synthesis to insulin and amino acids. We will test this by studying the effect of fish oil supplementation on the muscle protein synthesis process in young and older adults.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) < 30 kg/m2;
  • Age 18-45 yr; or
  • Age 65-85 yr

Exclusion Criteria:

  • Those taking medications known to affect substrate metabolism or medications that may confound the findings from our study (synthetic steroids, glucocorticoids etc.);
  • Those with evidence of significant organ system dysfunction (e.g. diabetes mellitis, cirrhosis, hypo- or hyperthyroidism; hypertension);
  • Body mass index > 30 kg/m2
  • Age <18 yr, 45-65 yr or > 85 yr
  • Those performing >1.5h of exercise/wk
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794079

Locations
United States, Missouri
Washington University in Saint Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Longer Life Foundation
American Federation for Aging Research
Reliant Pharmaceuticals
Investigators
Principal Investigator: Bettina Mittendorfer, PhD Washington University School of Medicine