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
  Purpose

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


Condition Intervention Phase
Inflammation
Dietary Supplement: Omega 3 (Fish Oil) Supplementation
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega-3 Dietary Supplementation, Immune Function, and Mood

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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.



Enrollment: 138
Study Start Date: September 2006
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1.25 g/d
Dietary Supplement: Omega 3 (Fish Oil) Supplementation
1.25 g or 2.496 g daily for 4 months
Experimental: 2
2.496 g/d
Dietary Supplement: Omega 3 (Fish Oil) Supplementation
1.25 g or 2.496 g daily for 4 months
Placebo Comparator: 3 Dietary Supplement: Placebo
matching placebo capsule daily for 4 months

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385723

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Janice K. Kiecolt-Glaser Ohio State University
  More Information

Additional Information:
Publications:
Responsible Party: Janice Kiecolt-Glaser, Professor of Psychiatry and Psychology, Ohio State University
ClinicalTrials.gov Identifier: NCT00385723     History of Changes
Other Study ID Numbers: AG0087, 2006H0054, R01AG029562
Study First Received: October 10, 2006
Results First Received: August 28, 2012
Last Updated: November 13, 2012
Health Authority: United States: Federal Government

Keywords provided by Ohio State University:
affect
inflammation

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014