Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention

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

Study Overview

• Status: Completed
• Conditions: Stress-related Changes in Inflammation
• Intervention / Treatment: Dietary supplement: Oral omega-3 fish oil placebo; Dietary supplement: omega-3 supplementation

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

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo oral Omega-3 fish oil supplementation	Dietary supplement: Oral omega-3 fish oil placebo; to match experimental dosage
Experimental: 1; oral Omega-3 fish oil supplementation	Dietary supplement: omega-3 supplementation; 2.5 g/day omega-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
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.	every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
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.	every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
Stimulated ln(TNF-alpha)	log-transformed stimulated TNF-alpha	every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ln(Beck Anxiety Score)	log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety	every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
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.	every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)

Collaborators and Investigators

• Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Collaborators: Office of Dietary Supplements (ODS)
• Investigators: Principal Investigator: Janice K Kiecolt-Glaser, PhD, Ohio State University

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: August 21, 2007
• First Submitted That Met QC Criteria: August 21, 2007
• First Posted (Estimate): August 23, 2007

Study Record Updates

• Last Update Posted (Estimate): March 27, 2012
• Last Update Submitted That Met QC Criteria: March 22, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: inflammation; affect
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: R21AT003912-01A1 (U.S. NIH Grant/Contract); AT003912

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No