Omega-3 Fatty Acids and Muscle Protein Synthesis

August 2, 2011 updated by: Washington University School of Medicine
The purpose of this study is to determine whether omega-3 fatty acid supplementation influences muscle protein synthesis rates in young and older adults.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in Saint Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
omega-3 fatty acids
4 grams per day for 8 weeks
Other Names:
  • Lovaza
Placebo Comparator: B
corn oil
4 grams per day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measurements taken prior to and following 8 weeks of supplementation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Measurements taken prior to and following 8 weeks of supplementation
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
Measurements taken prior to and following 8 weeks of supplementation
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
prior to supplementation only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 18, 2008

First Submitted That Met QC Criteria

November 18, 2008

First Posted (Estimate)

November 19, 2008

Study Record Updates

Last Update Posted (Estimate)

August 3, 2011

Last Update Submitted That Met QC Criteria

August 2, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 06-1147

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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