Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention

Phase 2

Completed

Conditions: Stress-related Changes in Inflammation

Interventions: Dietary Supplement: Oral omega-3 fish oil placebo
Dietary Supplement: omega-3 supplementation

Registration Number: NCT00519779

Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 68

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Oral omega-3 fish oil placebo	Placebo oral Omega-3 fish oil supplementation
1	omega-3 supplementation	oral Omega-3 fish oil supplementation

Primary Outcome Measures

Name	Time	Method
Serum ln(IL-6)	every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)	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)	every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)	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)	every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)	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)	every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)	log-transformed stimulated TNF-alpha

Secondary Outcome Measures

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