Fish Oil (Omega 3), Immune Function, and Mood

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Janice Kiecolt-Glaser, Ohio State University
ClinicalTrials.gov Identifier:
NCT00385723
First received: October 10, 2006
Last updated: November 13, 2012
Last verified: November 2012

October 10, 2006
November 13, 2012
September 2006
February 2011   (final data collection date for primary outcome measure)
  • Serum ln(TNF-a) [ Time Frame: Baseline & 4 months ] [ Designated as safety issue: No ]
    log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)
  • Serum ln(IL-6) [ Time Frame: Baseline & 4 months ] [ Designated as safety issue: No ]
    log-transformed serum Interleukin-6 (IL-6)
  • ln(CES-D) [ Time Frame: Baseline & 4 months ] [ Designated as safety issue: No ]

    log-transformed Center for Epidemiologic Studies Depression Scale (CES-D) score The CES-D is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.

    Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms.

  • immune function
  • mood
Complete list of historical versions of study NCT00385723 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Fish Oil (Omega 3), Immune Function, and Mood
Omega-3 Dietary Supplementation, Immune Function, and Mood

This study is designed to examine the effects of fish oil on immune function and mood.

The beneficial effects of fish oil (or eating fish more frequently) include reductions in triglycerides, blood pressure, and heart rate, as well as increases in HDL cholesterol, the "good" type of cholesterol. In addition, certain aspects of immune function also appear to show favorable responses to fish oil supplementation, and some studies suggest that fish oil helps to improve mood and decrease depression.

This study is designed to examine how supplementation with omega-3 polyunsaturated fatty acids (key fish oil components) affects aspects of your immune response, and your mood; because some research suggests that people who eat more fish may do better during stressful times, the study will also examine how fish oil affects your immune response to stress, certain stress hormone responses, and your psychological response to stress.

For detailed information about the study, please visit our website at http://www.stressandhealth.org

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Inflammation
  • Dietary Supplement: Omega 3 (Fish Oil) Supplementation
    1.25 g or 2.496 g daily for 4 months
  • Dietary Supplement: Placebo
    matching placebo capsule daily for 4 months
  • Experimental: 1
    1.25 g/d
    Intervention: Dietary Supplement: Omega 3 (Fish Oil) Supplementation
  • Experimental: 2
    2.496 g/d
    Intervention: Dietary Supplement: Omega 3 (Fish Oil) Supplementation
  • Placebo Comparator: 3
    Intervention: Dietary Supplement: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
February 2011
February 2011   (final data collection date for primary outcome measure)

Recruiting men and women ages 40-88 from the Greater Columbus Ohio area. Participation involves taking capsules for 4 months and completing 6 appointments (for a total of 19.5 hours) at Ohio State.

Inclusion Criteria:

  • Healthy men and women
  • NOT currently taking any sort of fish oil or omega 3 supplement

Exclusion Criteria:

  • Use of blood pressure medicines, cholesterol-lowering drugs, steroids, or antidepressants
  • Certain lifestyle habits such as smoking or exercising vigorously for 2 or more hours a week may also exclude applicants from participating
Both
40 Years to 88 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00385723
AG0087, 2006H0054, R01AG029562
Yes
Janice Kiecolt-Glaser, Ohio State University
Ohio State University
National Institute on Aging (NIA)
Principal Investigator: Janice K. Kiecolt-Glaser Ohio State University
Ohio State University
November 2012

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