Stress-related Changes in Inflammation Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 68 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 40 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | The Ohio State University College of Medicine | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | Office of Dietary Supplements (ODS) |
United States,
Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Glaser R. Omega-3 supplementation lowers inflammation and anxiety in medical students: a randomized controlled trial. Brain Behav Immun. 2011 Nov;25(8):1725-34. doi: 10.1016/j.bbi.2011.07.229. Epub 20 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serum ln(IL-6) | 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. |
every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) | Yes |
| Primary | Serum ln(TNF-a) | 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. |
every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) | Yes |
| Primary | Stimulated ln(IL-6) | 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. |
every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) | Yes |
| Primary | Stimulated ln(TNF-alpha) | log-transformed stimulated TNF-alpha | every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) | Yes |
| Secondary | ln(Beck Anxiety Score) | log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety | every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) | No |
| Secondary | ln(CES-D) | 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. |
every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) | No |