Omega-3 Fatty Acid Supplementation in Older Adults

October 8, 2012 updated by: Zsolt Murlasits, University of Memphis

The Impact of Omega-3 Fatty Acid Supplementation on Markers of Inflammation and Lean Body Mass in Older Adults

The purpose of this study to determine whether Fish oil (Omega-3 Fatty Acid) supplementation has an impact on inflammation and lean body mass in older adults. The investigators expect that Fish oil supplementation will reduce inflammation and prevent the loss of lean mass compared to placebo.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38152
        • Department of Health and Sport Sciences, The University of Memphis

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 60 years of age or over

Exclusion Criteria:

  • Fish, seafood allergies, nut allergies, soy allergies
  • Habitual (>1/week) fish or seafood consumption
  • Current Omega-3 supplement use
  • Gastrointestinal problems
  • Current anti-inflammatory medication use
  • Current anticoagulant medication use

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fish oil (Omega-3 fatty acid)
2 capsules/day of ProOmega providing 650mg EPA and 450mg DHA
Dietary supplement: Omega-3 fatty acid
Omega-3 fatty acid, Eicosapentaenoic acid+docosahexaenoic acid in capsule form
Other Names:
  • ProOmega (Nordic Naturals)
Placebo Comparator: Soybean oil
2 capsules/day
Dietary supplement: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-Reactive protein
Time Frame: At baseline testing and at 3 month endpoint
Inflammatory marker
At baseline testing and at 3 month endpoint
IL6
Time Frame: At baseline and at 3 month endpoint
Inflammatory cytokine
At baseline and at 3 month endpoint
TNFα
Time Frame: At baseline and at 3 month endpoint
Inflammatory cytokine
At baseline and at 3 month endpoint

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal muscle mass/body composition
Time Frame: At baseline testing and at 3 month endpoint
The amount of skeletal muscle mass and fat mass and their ration will be determined.
At baseline testing and at 3 month endpoint
Lower body muscular strength
Time Frame: At baseline and at 3 month endpoint
Measurement of maximum strength in the leg press exercise
At baseline and at 3 month endpoint
Upper body muscular strength
Time Frame: At baseline and at 3 month endpoint
Measurement of maximum strength in the chest press exercise
At baseline and at 3 month endpoint

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
EPA and DHA
Time Frame: At baseline and at 3 month endpoint
To determine the effectiveness of fish oil supplementation, we measure EPA and DHA Omega-3 fatty acid levels
At baseline and at 3 month endpoint

Collaborators and Investigators

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

Sponsor

University of Memphis

Collaborators

Nordic Naturals

Investigators

  • Principal Investigator: Zsolt Murlasits, Ph.D., The University of Memphis

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

August 1, 2012

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

August 10, 2012

First Submitted That Met QC Criteria

August 15, 2012

First Posted (Estimate)

August 16, 2012

Study Record Updates

Last Update Posted (Estimate)

October 10, 2012

Last Update Submitted That Met QC Criteria

October 8, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #2232 (Other Identifier: The University of memphis)

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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