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Completed

NCT Number: NCT00519779

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.

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Key information

Conditions

Stress-related Changes in Inflammation Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Ohio State University College of Medicine

Columbus, Ohio, 43210, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 supplementation

Dietary Supplement

2.5 g/day omega-3

Oral omega-3 fish oil placebo

Dietary Supplement

to match experimental dosage

Primary outcomes

  1. Serum ln(IL-6)

    Time frame: 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.

  2. Serum ln(TNF-a)

    Time frame: 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.

  3. Stimulated ln(IL-6)

    Time frame: 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.

  4. Stimulated ln(TNF-alpha)

    Time frame: 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 outcomes

  1. ln(Beck Anxiety Score)

    Time frame: 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

  2. ln(CES-D)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Collaborators

  • Office of Dietary Supplements (ODS)

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Aug 23, 2007
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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