Fish Oil (Omega 3), Immune Function, and Mood - Full Text View

Sponsor:	National Institute on Aging (NIA)
Collaborator:	Ohio State University
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00385723

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Omega-3 Dietary Supplementation, Immune Function, and Mood

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Fish oil

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

immune function [ Time Frame: Baseline & 4 months ] [ Designated as safety issue: No ]
mood [ Time Frame: Baseline & 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

stress-related increases in cytokine production and negative mood following laboratory stressors [ Time Frame: Baseline & 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	138
Study Start Date:	September 2006
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 1.25 g/d	Dietary Supplement: Omega 3 (Fish Oil) Supplementation 1.25 g or 2.496 g daily for 4 months
2: Experimental 2.496 g/d	Dietary Supplement: Omega 3 (Fish Oil) Supplementation 1.25 g or 2.496 g daily for 4 months
3: Placebo Comparator	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

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

Contacts

Contact: Lindsay Madaras	614-293-4736	stressandhealth@sumc.edu
Contact: Michael Di Gregorio	614-293--4537	michael.digregorio@sumc.edu

Locations

United States, Ohio
The Ohio State University	Recruiting
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

National Institute on Aging (NIA)

Ohio State University

Investigators

Principal Investigator:

Janice K. Kiecolt-Glaser

Ohio State University

More Information

Additional Information:

Please click here to visit our website if you would like to read more about the study or apply to participate. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ohio State University College of Medicine ( Janice Kiecolt-Glaser, PhD )
Study ID Numbers:	AG0087, 2006H0054, R01 AG029562
Study First Received:	October 10, 2006
Last Updated:	December 17, 2009
ClinicalTrials.gov Identifier:	NCT00385723 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

affect
inflammation

Additional relevant MeSH terms:

Pathologic Processes
Inflammation

ClinicalTrials.gov processed this record on February 08, 2010