We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00385723
Recruitment Status : Completed
First Posted : October 11, 2006
Results First Posted : November 8, 2012
Last Update Posted : November 20, 2012
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Janice Kiecolt-Glaser, Ohio State University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is designed to examine the effects of fish oil on immune function and mood.

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

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega-3 Dietary Supplementation, Immune Function, and Mood
Study Start Date : September 2006
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Serum ln(TNF-a) [ Time Frame: Baseline & 4 months ]
    log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)

  2. Serum ln(IL-6) [ Time Frame: Baseline & 4 months ]
    log-transformed serum Interleukin-6 (IL-6)

  3. ln(CES-D) [ Time Frame: Baseline & 4 months ]

    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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385723


Locations
Layout table for location information
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Janice K. Kiecolt-Glaser Ohio State University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Janice Kiecolt-Glaser, Professor of Psychiatry and Psychology, Ohio State University
ClinicalTrials.gov Identifier: NCT00385723    
Other Study ID Numbers: AG0087
2006H0054
R01AG029562 ( U.S. NIH Grant/Contract )
First Posted: October 11, 2006    Key Record Dates
Results First Posted: November 8, 2012
Last Update Posted: November 20, 2012
Last Verified: November 2012
Keywords provided by Janice Kiecolt-Glaser, Ohio State University:
affect
inflammation
Additional relevant MeSH terms:
Layout table for MeSH terms
Inflammation
Pathologic Processes