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

Phase 2

Completed

• Conditions: Inflammation
• Interventions: Dietary Supplement: Omega 3 (Fish Oil) Supplementation; Dietary Supplement: Placebo

• Registration Number: NCT00385723
• Lead Sponsor: Ohio State University

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-11
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2012-08-28
• Results First Submitted QC: 2012-10-09
• Status Verified: 2012-11
• Results First Posted: 2012-11-08
• Last Update Submitted: 2012-11-13
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Omega 3 (Fish Oil) Supplementation	1.25 g/d
2	Omega 3 (Fish Oil) Supplementation	2.496 g/d
3	Placebo	-

Primary Outcome Measures

Name	Time	Method
Serum ln(TNF-a)	Baseline & 4 months	log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)
Serum ln(IL-6)	Baseline & 4 months	log-transformed serum Interleukin-6 (IL-6)
ln(CES-D)	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.

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States