Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention

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

Detailed Description
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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

Official Title
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Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention

Conditions
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Stress-related Changes in Inflammation

Intervention / Treatment
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* Dietary Supplement: omega-3 supplementation
* Dietary Supplement: Oral omega-3 fish oil placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>Placebo oral Omega-3 fish oil supplementation | Dietary Supplement: Oral omega-3 fish oil placebo<br>* to match experimental dosage<br>|
| Experimental: 1<br>oral Omega-3 fish oil supplementation | Dietary Supplement: omega-3 supplementation<br>* 2.5 g/day omega-3<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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affect, inflammation