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OpenTrials
Completed

NCT Number: NCT00385723

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

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

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega 3 (Fish Oil) Supplementation

Dietary Supplement

1.25 g or 2.496 g daily for 4 months

Placebo

Dietary Supplement

matching placebo capsule daily for 4 months

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Omega-3 Dietary Supplementation, Immune Function, and Mood

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Oct 11, 2006
Registry last updated
Nov 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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