search
Back to results

Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention

Primary Purpose

Stress-related Changes in Inflammation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
omega-3 supplementation
Oral omega-3 fish oil placebo
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress-related Changes in Inflammation focused on measuring affect, inflammation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • OSU preclinical medical or dental student, or graduate nursing student
  • male or female

Exclusion Criteria:

  • taking certain medications with immune or endocrine effects
  • chronic health conditions
  • smoking
  • excessive use of alcohol or caffeine
  • significant digestive problems
  • routine use of fish oil or flaxseed supplements or high fish intake
  • fish allergy

Sites / Locations

  • The Ohio State University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

Placebo oral Omega-3 fish oil supplementation

oral Omega-3 fish oil supplementation

Outcomes

Primary Outcome Measures

Serum ln(IL-6)
log-transformed serum Interleukin-6 (IL-6) Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill. Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes.
Serum ln(TNF-a)
log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha) All cytokine measurements (e.g., IL-6 and TNF-a, serum and stimulated) were analyzed across time; however, no stress effects were found. Therefore, all assessments post-supplementation were averaged (time points 3-6) and analyzed to determine whether fish oil supplementation had an effect. Pooling these 4 assessments provides a better estimate of an individual's cytokine levels because single time point measurements can be affected by changes in exercise, alcohol consumption, or sleep in the preceding 24-48 hours.
Stimulated ln(IL-6)
log-transformed stimulated IL-6 Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill. Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes.
Stimulated ln(TNF-alpha)
log-transformed stimulated TNF-alpha

Secondary Outcome Measures

ln(Beck Anxiety Score)
log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety
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.

Full Information

First Posted
August 21, 2007
Last Updated
March 22, 2012
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00519779
Brief Title
Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention
Official Title
Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to examine the effects of fish oil on immune function and mood in medical students.
Detailed Description
This study will examine how supplementation with omega-3 polyunsaturated fatty acids (key fish oil components) affects immune and mood responses to examination stress. This study will examine these outcomes in medical students during academic examination periods as well as less stressful non-exam periods. Participants will take fish oil supplements or placebo pills for approximately 3 months during which time relevant mood, endocrine, and immune measures will be assessed. 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
Stress-related Changes in Inflammation
Keywords
affect, inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo oral Omega-3 fish oil supplementation
Arm Title
1
Arm Type
Experimental
Arm Description
oral Omega-3 fish oil supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
omega-3 supplementation
Intervention Description
2.5 g/day omega-3
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral omega-3 fish oil placebo
Intervention Description
to match experimental dosage
Primary Outcome Measure Information:
Title
Serum ln(IL-6)
Description
log-transformed serum Interleukin-6 (IL-6) Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill. Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes.
Time Frame
every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
Title
Serum ln(TNF-a)
Description
log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha) All cytokine measurements (e.g., IL-6 and TNF-a, serum and stimulated) were analyzed across time; however, no stress effects were found. Therefore, all assessments post-supplementation were averaged (time points 3-6) and analyzed to determine whether fish oil supplementation had an effect. Pooling these 4 assessments provides a better estimate of an individual's cytokine levels because single time point measurements can be affected by changes in exercise, alcohol consumption, or sleep in the preceding 24-48 hours.
Time Frame
every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
Title
Stimulated ln(IL-6)
Description
log-transformed stimulated IL-6 Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill. Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes.
Time Frame
every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
Title
Stimulated ln(TNF-alpha)
Description
log-transformed stimulated TNF-alpha
Time Frame
every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
Secondary Outcome Measure Information:
Title
ln(Beck Anxiety Score)
Description
log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety
Time Frame
every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
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
every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: OSU preclinical medical or dental student, or graduate nursing student male or female Exclusion Criteria: taking certain medications with immune or endocrine effects chronic health conditions smoking excessive use of alcohol or caffeine significant digestive problems routine use of fish oil or flaxseed supplements or high fish intake fish allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice K Kiecolt-Glaser, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University College of Medicine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21784145
Citation
Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Glaser R. Omega-3 supplementation lowers inflammation and anxiety in medical students: a randomized controlled trial. Brain Behav Immun. 2011 Nov;25(8):1725-34. doi: 10.1016/j.bbi.2011.07.229. Epub 2011 Jul 19.
Results Reference
result
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

Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention

We'll reach out to this number within 24 hrs