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

This study has been completed.

Sponsor:

Collaborator:

National Institute on Aging (NIA)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 10, 2006

Last Updated Date

November 13, 2012

Start Date ^ICMJE

September 2006

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

immune function
mood

Change History

Complete list of historical versions of study NCT00385723 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Omega-3 Dietary Supplementation, Immune Function, and Mood

Brief Summary

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Inflammation

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

138

Completion Date

February 2011

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 88 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00385723

Other Study ID Numbers ^ICMJE

AG0087, 2006H0054, R01AG029562

Has Data Monitoring Committee

Yes

Responsible Party

Janice Kiecolt-Glaser, Ohio State University

Study Sponsor ^ICMJE

Ohio State University

Collaborators ^ICMJE

National Institute on Aging (NIA)

Investigators ^ICMJE

Principal Investigator:

Janice K. Kiecolt-Glaser

Ohio State University

Information Provided By

Ohio State University

Verification Date

November 2012

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

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