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

Primary Purpose

Inflammation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omega 3 (Fish Oil) Supplementation
Placebo
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation focused on measuring affect, inflammation

Eligibility Criteria

40 Years - 88 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

1.25 g/d

2.496 g/d

Outcomes

Primary Outcome Measures

Serum ln(TNF-a)
log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)
Serum ln(IL-6)
log-transformed serum Interleukin-6 (IL-6)
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.

Secondary Outcome Measures

Full Information

First Posted
October 10, 2006
Last Updated
November 13, 2012
Sponsor
Ohio State University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00385723
Brief Title
Fish Oil (Omega 3), Immune Function, and Mood
Official Title
Omega-3 Dietary Supplementation, Immune Function, and Mood
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
affect, inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
1.25 g/d
Arm Title
2
Arm Type
Experimental
Arm Description
2.496 g/d
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega 3 (Fish Oil) Supplementation
Intervention Description
1.25 g or 2.496 g daily for 4 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
matching placebo capsule daily for 4 months
Primary Outcome Measure Information:
Title
Serum ln(TNF-a)
Description
log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)
Time Frame
Baseline & 4 months
Title
Serum ln(IL-6)
Description
log-transformed serum Interleukin-6 (IL-6)
Time Frame
Baseline & 4 months
Title
ln(CES-D)
Description
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.
Time Frame
Baseline & 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice K. Kiecolt-Glaser
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22640930
Citation
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.2012.05.011. Epub 2012 May 26.
Results Reference
result
PubMed Identifier
23010452
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/j.bbi.2012.09.004. Epub 2012 Sep 23.
Results Reference
result
PubMed Identifier
33875799
Citation
Madison AA, Belury MA, Andridge R, Renna ME, Rosie Shrout M, Malarkey WB, Lin J, Epel ES, Kiecolt-Glaser JK. Omega-3 supplementation and stress reactivity of cellular aging biomarkers: an ancillary substudy of a randomized, controlled trial in midlife adults. Mol Psychiatry. 2021 Jul;26(7):3034-3042. doi: 10.1038/s41380-021-01077-2. Epub 2021 Apr 20.
Results Reference
derived
PubMed Identifier
25264972
Citation
Jaremka LM, Derry HM, Bornstein R, Prakash RS, Peng J, Belury MA, Andridge RR, Malarkey WB, Kiecolt-Glaser JK. Omega-3 supplementation and loneliness-related memory problems: secondary analyses of a randomized controlled trial. Psychosom Med. 2014 Oct;76(8):650-8. doi: 10.1097/PSY.0000000000000104.
Results Reference
derived
Links:
URL
http://www.stressandhealth.org
Description
Please click here to visit our website if you would like to read more about the study or apply to participate.

Learn more about this trial

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

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