## Protocol Section
### Identification Module
**NCT ID:** NCT00519779

**Brief Title:** Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention

**Official Title:** Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention

#### Organization Study ID Info
**ID:** R21AT003912-01A1
**Link:** https://reporter.nih.gov/quickSearch/R21AT003912-01A1
**Type:** NIH
#### Organization
**Class:** NIH
**Full Name:** National Center for Complementary and Integrative Health (NCCIH)
#### Secondary ID Infos
**ID:** AT003912
### Status Module
#### Completion Date
**Date:** 2010-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-03-27

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-03-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2012-03-22

**Type:** ESTIMATED

**Results First Submit Date:** 2011-11-07

**Results First Submit QC Date:** 2012-02-16

#### Start Date
**Date:** 2007-07

**Status Verified Date:** 2012-02

#### Study First Post Date
**Date:** 2007-08-23
**Type:** ESTIMATED
**Study First Submit Date:** 2007-08-21
**Study First Submit QC Date:** 2007-08-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** Office of Dietary Supplements (ODS)

#### Lead Sponsor

**Class:** NIH

**Name:** National Center for Complementary and Integrative Health (NCCIH)

#### Responsible Party

**Investigator Affiliation:** National Center for Complementary and Integrative Health (NCCIH)

**Investigator Full Name:** Janice Kiecolt-Glaser

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

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

**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

### Conditions Module

**Conditions:**

- Stress-related Changes in Inflammation

**Keywords:**

- affect

- inflammation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 68

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Placebo oral Omega-3 fish oil supplementation

**Intervention Names:**

- Dietary Supplement: Oral omega-3 fish oil placebo

**Label:** 2

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** oral Omega-3 fish oil supplementation

**Intervention Names:**

- Dietary Supplement: omega-3 supplementation

**Label:** 1

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** 2.5 g/day omega-3

**Name:** omega-3 supplementation

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- 2

**Description:** to match experimental dosage

**Name:** Oral omega-3 fish oil placebo

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** 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)

**Description:** 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.

**Measure:** 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)

**Description:** 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.

**Measure:** 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)

**Description:** log-transformed stimulated TNF-alpha

**Measure:** 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)

#### Secondary Outcomes

**Description:** log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety

**Measure:** 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)

**Description:** 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.

**Measure:** 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)

### Eligibility Module

**Eligibility 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

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Columbus

**Country:** United States

**Facility:** The Ohio State University College of Medicine

**State:** Ohio

**Zip:** 43210

#### Overall Officials

**Official 1:**

**Affiliation:** Ohio State University

**Name:** Janice K Kiecolt-Glaser, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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.

**PMID:** 21784145

#### See Also Links

**Label:** Please click here to visit our website if you would like to read more about the study or apply to participate.

**URL:** http://www.stressandhealth.org

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

### Condition Browse Module - Meshes

- ID: D000007249

- Term: Inflammation

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T415

- Name: Omega 3 Fatty Acid

- Relevance: HIGH

- As Found: Diabetic

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Placebo

**Description:** Placebo oral Omega-3 fish oil supplementation

**ID:** EG000

**Other Num Affected:** 18

**Other Num at Risk:** 34

**Serious Number At Risk:** 34

**Title:** Placebo

**Group ID:** EG001

**Title:** Omega-3 Fish Oil Supplement

**Description:** 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 \[DHA\])

**ID:** EG001

**Other Num Affected:** 20

**Other Num at Risk:** 34

**Serious Number At Risk:** 34

**Title:** Omega-3 Fish Oil Supplement

**Frequency Threshold:** 5

#### Other Events

**Term:** Sore throat

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Nasal symptoms

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Stomach pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Tachycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Diarrhea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Skin rash

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Heartburn

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Time Frame:** 3 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 34

**Group ID:** BG001

**Value:** 34

**Group ID:** BG002

**Value:** 68

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo

**Description:** Placebo oral Omega-3 fish oil supplementation

### Group

**ID:** BG001

**Title:** Omega-3 Fish Oil Supplement

**Description:** 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 \[DHA\])

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 34

#### Measurement

**Group ID:** BG001

**Value:** 34

#### Measurement

**Group ID:** BG002

**Value:** 68

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.7

**Value:** 23.4

#### Measurement

**Group ID:** BG001

**Spread:** 2.0

**Value:** 23.9

#### Measurement

**Group ID:** BG002

**Spread:** 1.9

**Value:** 23.6

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 14

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 30

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 38

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 34

#### Measurement

**Group ID:** BG001

**Value:** 34

#### Measurement

**Group ID:** BG002

**Value:** 68

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** Janice.Kiecolt-Glaser@osumc.edu
**Organization:** The Ohio State University
**Phone:** 614-293-3499
**Title:** Dr. Janice Kiecolt-Glaser
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -0.18
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.18
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.090
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.97
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.0033
**Statistical Comment:** adjusted for baseline value, visit, gender, SAD
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -0.44
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.011
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.11
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.04
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.23
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -0.15
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.002
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.039
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.06
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.076
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -0.30
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.009
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.072
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.04
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.15
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** -0.33
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.018
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.086
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.08
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.15
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** -0.26
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.29
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.14
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.93
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.012
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.070
- **Upper Limit:** 
- **Value:** 0.054
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.069
- **Upper Limit:** 
- **Value:** 0.051
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.075
- **Upper Limit:** 
- **Value:** 1.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.076
- **Upper Limit:** 
- **Value:** 0.93
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.028
- **Upper Limit:** 
- **Value:** 0.61
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.027
- **Upper Limit:** 
- **Value:** 0.54
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.051
- **Upper Limit:** 
- **Value:** 11.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.050
- **Upper Limit:** 
- **Value:** 10.9
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.061
- **Upper Limit:** 
- **Value:** 7.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.060
- **Upper Limit:** 
- **Value:** 7.3
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.097
- **Upper Limit:** 
- **Value:** 1.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.098
- **Upper Limit:** 
- **Value:** 1.6
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** intention to treat
**Reporting Status:** POSTED
**Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
**Title:** Serum ln(IL-6)
**Type:** PRIMARY
**Unit of Measure:** ln(pg/mL)
##### Group
**Description:** Placebo oral Omega-3 fish oil supplementation
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** 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 \[DHA\])
**ID:** OG001
**Title:** Omega-3 Fish Oil Supplement
#### Outcome Measure 2
**Description:** log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** intention to treat
**Reporting Status:** POSTED
**Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
**Title:** ln(Beck Anxiety Score)
**Type:** SECONDARY
**Unit of Measure:** units
##### Group
**Description:** Placebo oral Omega-3 fish oil supplementation
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** 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 \[DHA\])
**ID:** OG001
**Title:** Omega-3 Fish Oil Supplement
#### Outcome Measure 3
**Description:** 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.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** intention to treat
**Reporting Status:** POSTED
**Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
**Title:** Serum ln(TNF-a)
**Type:** PRIMARY
**Unit of Measure:** ln(pg/mL)
##### Group
**Description:** Placebo oral Omega-3 fish oil supplementation
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** 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 \[DHA\])
**ID:** OG001
**Title:** Omega-3 Fish Oil Supplement
#### Outcome Measure 4
**Description:** 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.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** intent to treat
**Reporting Status:** POSTED
**Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
**Title:** Stimulated ln(IL-6)
**Type:** PRIMARY
**Unit of Measure:** ln(pg/mL)
##### Group
**Description:** Placebo oral Omega-3 fish oil supplementation
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** 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 \[DHA\])
**ID:** OG001
**Title:** Omega-3 Fish Oil Supplement
#### Outcome Measure 5
**Description:** log-transformed stimulated TNF-alpha
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** intention to treat
**Reporting Status:** POSTED
**Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
**Title:** Stimulated ln(TNF-alpha)
**Type:** PRIMARY
**Unit of Measure:** ln(pg/mL)
##### Group
**Description:** Placebo oral Omega-3 fish oil supplementation
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** 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 \[DHA\])
**ID:** OG001
**Title:** Omega-3 Fish Oil Supplement
#### Outcome Measure 6
**Description:** 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.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** intention to treat
**Reporting Status:** POSTED
**Time Frame:** every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
**Title:** ln(CES-D)
**Type:** SECONDARY
**Unit of Measure:** scores on a
##### Group
**Description:** Placebo oral Omega-3 fish oil supplementation
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** 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 \[DHA\])
**ID:** OG001
**Title:** Omega-3 Fish Oil Supplement
### Participant Flow Module
#### Group
**Description:** Placebo oral Omega-3 fish oil supplementation
**ID:** FG000
**Title:** Placebo
#### Group
**Description:** 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 \[DHA\])
**ID:** FG001
**Title:** Omega-3 Fish Oil Supplement
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 34
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 34
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 34
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 33
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
**Has Results:** True