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| ID | Type | Description | Link |
|---|---|---|---|
| AT003912 |
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| Name | Class |
|---|---|
| Office of Dietary Supplements (ODS) | NIH |
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This study is designed to examine the effects of fish oil on immune function and mood in medical students.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | Placebo oral Omega-3 fish oil supplementation |
|
| 1 | Experimental | oral Omega-3 fish oil supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega-3 supplementation | Dietary Supplement | 2.5 g/day omega-3 |
| |
| Oral omega-3 fish oil placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| ln(CES-D) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janice K Kiecolt-Glaser, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University College of Medicine | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21784145 | Result | 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 2011 Jul 19. |
| Label | URL |
|---|---|
| Please click here to visit our website if you would like to read more about the study or apply to participate. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo oral Omega-3 fish oil supplementation |
| FG001 | Omega-3 Fish Oil Supplement | oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA]) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo oral Omega-3 fish oil supplementation |
| BG001 | Omega-3 Fish Oil Supplement | oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA]) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | intention to treat | Posted | Least Squares Mean | Standard Error | ln(pg/mL) | every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo oral Omega-3 fish oil supplementation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Janice Kiecolt-Glaser | The Ohio State University | 614-293-3499 | Janice.Kiecolt-Glaser@osumc.edu |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Dietary Supplement |
to match experimental dosage |
|
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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
|
|
|
| Secondary | ln(Beck Anxiety Score) | log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety | intention to treat | Posted | Least Squares Mean | Standard Error | units | every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) |
|
|
|
|
| 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. | intention to treat | Posted | Least Squares Mean | Standard Error | ln(pg/mL) | every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) |
|
|
|
|
| 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. | intent to treat | Posted | Least Squares Mean | Standard Error | ln(pg/mL) | every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) |
|
|
|
|
| Primary | Stimulated ln(TNF-alpha) | log-transformed stimulated TNF-alpha | intention to treat | Posted | Least Squares Mean | Standard Error | ln(pg/mL) | every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) |
|
|
|
|
| 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. | intention to treat | Posted | Least Squares Mean | Standard Error | scores on a | every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points) |
|
|
|
|
| 0 |
| 34 |
| 18 |
| 34 |
| EG001 | Omega-3 Fish Oil Supplement | oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA]) | 0 | 34 | 20 | 34 |
| Nasal symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Heartburn | Cardiac disorders | Non-systematic Assessment |
|
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