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

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

Detailed Description
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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

Official Title
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Omega-3 Dietary Supplementation, Immune Function, and Mood

Conditions
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Inflammation

Intervention / Treatment
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* Dietary Supplement: Omega 3 (Fish Oil) Supplementation
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1.25 g/d | Dietary Supplement: Omega 3 (Fish Oil) Supplementation<br>* 1.25 g or 2.496 g daily for 4 months<br>|
| Experimental: 2<br>2.496 g/d | Dietary Supplement: Omega 3 (Fish Oil) Supplementation<br>* 1.25 g or 2.496 g daily for 4 months<br>|
| Placebo Comparator: 3<br> | Dietary Supplement: Placebo<br>* matching placebo capsule daily for 4 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum ln(TNF-a) | log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha) | Baseline & 4 months | 
| Serum ln(IL-6) | log-transformed serum Interleukin-6 (IL-6) | Baseline & 4 months | 
| ln(CES-D) | 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. | Baseline & 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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affect, inflammation