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Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00519779
Recruitment Status : Completed
First Posted : August 23, 2007
Results First Posted : March 22, 2012
Last Update Posted : March 27, 2012
Sponsor:
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Janice Kiecolt-Glaser, 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.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention
Study Start Date : July 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519779


Locations
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United States, Ohio
The Ohio State University College of Medicine
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Investigators
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Principal Investigator: Janice K Kiecolt-Glaser, PhD Ohio State University
Additional Information:
Publications of Results:
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Responsible Party: Janice Kiecolt-Glaser, Professor, National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier: NCT00519779    
Other Study ID Numbers: R21AT003912-01A1 ( U.S. NIH Grant/Contract )
AT003912
First Posted: August 23, 2007    Key Record Dates
Results First Posted: March 22, 2012
Last Update Posted: March 27, 2012
Last Verified: February 2012
Keywords provided by Janice Kiecolt-Glaser, National Center for Complementary and Integrative Health (NCCIH):
affect
inflammation
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes