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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This study has been withdrawn prior to enrollment.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

August 10, 2012
October 8, 2012
August 2012
April 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01666392 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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
Same as current
 
Omega-3 Fatty Acid Supplementation in Older Adults
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Inflammation
  • Dietary Supplement: Omega-3 fatty acid
    Omega-3 fatty acid, Eicosapentaenoic acid+docosahexaenoic acid in capsule form
    Other Name: ProOmega (Nordic Naturals)
  • Dietary Supplement: Placebo
    Placebo
  • Experimental: Fish oil (Omega-3 fatty acid)
    2 capsules/day of ProOmega providing 650mg EPA and 450mg DHA
    Intervention: Dietary Supplement: Omega-3 fatty acid
  • Placebo Comparator: Soybean oil
    2 capsules/day
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01666392
#2232, #2232
No
Zsolt Murlasits, University of Memphis
University of Memphis
Nordic Naturals
Principal Investigator: Zsolt Murlasits, Ph.D. The University of Memphis
University of Memphis
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP