Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention
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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 |
- 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
- 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 |
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| United States, Ohio | |
| The Ohio State University College of Medicine | |
| Columbus, Ohio, United States, 43210 | |
| 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 May 19, 2013