Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Janice Kiecolt-Glaser, National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00519779
First received: August 21, 2007
Last updated: March 22, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Stress-related Changes in Inflammation
Dietary Supplement: omega-3 supplementation
Dietary Supplement: Oral omega-3 fish oil placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

    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) [ Time Frame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) ] [ Designated as safety issue: Yes ]

    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) [ Time Frame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) ] [ Designated as safety issue: Yes ]

    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) [ Time Frame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) ] [ Designated as safety issue: Yes ]
    log-transformed stimulated TNF-alpha


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety

  • 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) ] [ Designated as safety issue: No ]

    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.



Enrollment: 68
Study Start Date: July 2007
Study Completion Date: December 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Placebo oral Omega-3 fish oil supplementation
Dietary Supplement: Oral omega-3 fish oil placebo
to match experimental dosage
Other Name: Oral omega-3 fish oil placebo
Experimental: 1
oral Omega-3 fish oil supplementation
Dietary Supplement: omega-3 supplementation
2.5 g/day omega-3
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519779

Locations
United States, Ohio
The Ohio State University College of Medicine
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Investigators
Principal Investigator: Janice K Kiecolt-Glaser, PhD Ohio State University
  More Information

Additional Information:
Publications:
Responsible Party: Janice Kiecolt-Glaser, Professor, National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00519779     History of Changes
Other Study ID Numbers: R21 AT003912-01A1, AT003912
Study First Received: August 21, 2007
Results First Received: November 7, 2011
Last Updated: March 22, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
affect
inflammation

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 09, 2014