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Omega-3 Fatty Acid Supplementation in Older Adults

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Nordic Naturals
Information provided by (Responsible Party):
Zsolt Murlasits, University of Memphis
ClinicalTrials.gov Identifier:
NCT01666392
First received: August 10, 2012
Last updated: October 8, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Inflammation
 Dietary Supplement: Omega-3 fatty acid
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Impact of Omega-3 Fatty Acid Supplementation on Markers of Inflammation and Lean Body Mass in Older Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Memphis:

Primary Outcome Measures:
  • C-Reactive protein [ Time Frame: At baseline testing and at 3 month endpoint ] [ Designated as safety issue: No ]
    Inflammatory marker

  • IL6 [ Time Frame: At baseline and at 3 month endpoint ] [ Designated as safety issue: No ]
    Inflammatory cytokine

  • TNFα [ Time Frame: At baseline and at 3 month endpoint ] [ Designated as safety issue: No ]
    Inflammatory cytokine


Secondary Outcome Measures:
  • Skeletal muscle mass/body composition [ Time Frame: At baseline testing and at 3 month endpoint ] [ Designated as safety issue: No ]
    The amount of skeletal muscle mass and fat mass and their ration will be determined.

  • Lower body muscular strength [ Time Frame: At baseline and at 3 month endpoint ] [ Designated as safety issue: No ]
    Measurement of maximum strength in the leg press exercise

  • Upper body muscular strength [ Time Frame: At baseline and at 3 month endpoint ] [ Designated as safety issue: No ]
    Measurement of maximum strength in the chest press exercise


Other Outcome Measures:
  • EPA and DHA [ Time Frame: At baseline and at 3 month endpoint ] [ Designated as safety issue: No ]
    To determine the effectiveness of fish oil supplementation, we measure EPA and DHA Omega-3 fatty acid levels


Enrollment: 0
Study Start Date: August 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ProOmega (Nordic Naturals)
Placebo Comparator: Soybean oil
2 capsules/day
 Dietary Supplement: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666392

Locations
United States, Tennessee
Department of Health and Sport Sciences, The University of Memphis
Memphis, Tennessee, United States, 38152
Sponsors and Collaborators
University of Memphis
Nordic Naturals
Investigators
Principal Investigator: Zsolt Murlasits, Ph.D. The University of Memphis
  More Information

No publications provided

Responsible Party: Zsolt Murlasits, Assistant Professor, University of Memphis
ClinicalTrials.gov Identifier: NCT01666392     History of Changes
Other Study ID Numbers: #2232, #2232
Study First Received: August 10, 2012
Last Updated: October 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Memphis:
Omega-3 fatty acid
Fish oil
Muscle mass
Muscle strength
Older adults
 Circulating inflammatory cytokines
Skeletal muscle mass
Upper body strength
Lower body strength

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013