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

Inflammation Clinical Trial

Official title:

Omega-3 Dietary Supplementation, Immune Function, and Mood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385723
• Other study ID #: AG0087
• Secondary ID: 2006H0054R01AG02
• Status: Completed
• Phase: Phase 2
• First received: October 10, 2006
• Last updated: November 13, 2012
• Start date: September 2006
• Est. completion date: February 2011

Study information

• Verified date: November 2012
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 88 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Inflammation

Intervention

Dietary Supplement:
• Omega 3 (Fish Oil) Supplementation
1.25 g or 2.496 g daily for 4 months
• Placebo
matching placebo capsule daily for 4 months

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Hwang BS, Glaser R. Omega-3 supplementation lowers inflammation in healthy middle-aged and older adults: a randomized controlled trial. Brain Behav Immun. 2012 Aug;26(6):988-95. doi: 10.1016/j.bbi.201 — View Citation

Kiecolt-Glaser JK, Epel ES, Belury MA, Andridge R, Lin J, Glaser R, Malarkey WB, Hwang BS, Blackburn E. Omega-3 fatty acids, oxidative stress, and leukocyte telomere length: A randomized controlled trial. Brain Behav Immun. 2013 Feb;28:16-24. doi: 10.1016 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum ln(TNF-a)	log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)	Baseline & 4 months	No
Primary	Serum ln(IL-6)	log-transformed serum Interleukin-6 (IL-6)	Baseline & 4 months	No
Primary	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	No

External Links

•   Please click here to visit our website if you would like to read more about the study or apply to participate.