Inflammation
Conditions
Keywords
affect, inflammation
Brief summary
This study is designed to examine the effects of fish oil on immune function and mood.
Detailed description
The beneficial effects of fish oil (or eating fish more frequently) include reductions in triglycerides, blood pressure, and heart rate, as well as increases in HDL cholesterol, the good type of cholesterol. In addition, certain aspects of immune function also appear to show favorable responses to fish oil supplementation, and some studies suggest that fish oil helps to improve mood and decrease depression. This study is designed to examine how supplementation with omega-3 polyunsaturated fatty acids (key fish oil components) affects aspects of your immune response, and your mood; because some research suggests that people who eat more fish may do better during stressful times, the study will also examine how fish oil affects your immune response to stress, certain stress hormone responses, and your psychological response to stress. For detailed information about the study, please visit our website at http://www.stressandhealth.org
Interventions
DIETARY_SUPPLEMENTOmega 3 (Fish Oil) Supplementation
1.25 g or 2.496 g daily for 4 months
DIETARY_SUPPLEMENTPlacebo
matching placebo capsule daily for 4 months
Sponsors
National Institute on Aging (NIA)
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 88 Years
Healthy volunteers
Yes
Inclusion criteria
Recruiting men and women ages 40-88 from the Greater Columbus Ohio area. Participation involves taking capsules for 4 months and completing 6 appointments (for a total of 19.5 hours) at Ohio State. Inclusion Criteria: * Healthy men and women * NOT currently taking any sort of fish oil or omega 3 supplement
Exclusion criteria
* Use of blood pressure medicines, cholesterol-lowering drugs, steroids, or antidepressants * Certain lifestyle habits such as smoking or exercising vigorously for 2 or more hours a week may also exclude applicants from participating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum ln(TNF-a) | Baseline & 4 months | log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha) |
| Serum ln(IL-6) | Baseline & 4 months | log-transformed serum Interleukin-6 (IL-6) |
| ln(CES-D) | Baseline & 4 months | 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. |
Countries
United States
Participant flow
Recruitment details
Data collection for this double-blind placebo-controlled four month randomized clinical trial began in September, 2006 and ended in February, 2011. Ohio State University campus and community print and web-based announcements were used for recruitment.
Pre-assignment details
We used participants' ability to follow the regimen as a criterion for study entry. Participants received a 7-day supply of placebo capsules (single blind) at the subsequent in-person screening session, and those who had taken less than 80% of the capsules a week later were dropped before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo : matching placebo capsule daily for 4 months | 46 |
| 1.25 g/d n-3 Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months | 46 |
| 2.5 g/d n-3 Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months | 46 |
| Total | 138 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo | 1.25 g/d n-3 | 2.5 g/d n-3 | Total |
|---|---|---|---|---|
| Age Continuous | 51.1 years STANDARD_DEVIATION 8.6 | 51.1 years STANDARD_DEVIATION 8 | 51.0 years STANDARD_DEVIATION 6.7 | 51.0 years STANDARD_DEVIATION 7.8 |
| CES-D | 5 scores on a scale | 5 scores on a scale | 6 scores on a scale | 5 scores on a scale |
| Race/Ethnicity, Customized Asian | 2 participants | 1 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized Black | 9 participants | 5 participants | 8 participants | 22 participants |
| Race/Ethnicity, Customized Other | 2 participants | 1 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized White | 33 participants | 39 participants | 37 participants | 109 participants |
| Sagittal abdominal diameter | 22.8 cm STANDARD_DEVIATION 3.2 | 23.9 cm STANDARD_DEVIATION 3.4 | 22.9 cm STANDARD_DEVIATION 2.9 | 22.8 cm STANDARD_DEVIATION 3 |
| Sex: Female, Male Female | 36 Participants | 28 Participants | 29 Participants | 93 Participants |
| Sex: Female, Male Male | 10 Participants | 18 Participants | 17 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 42 / 46 | 38 / 46 | 40 / 46 |
| serious Total, serious adverse events | 0 / 46 | 0 / 46 | 0 / 46 |
Outcome results
Primary
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.
Time frame: Baseline & 4 months
Population: intention to treat
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | ln(CES-D) | Baseline (visit 1) | 1.5 scores on a scale | Standard Error 0.17 |
| Placebo | ln(CES-D) | Change, visit 1 to 5 | -0.056 scores on a scale | Standard Error 0.15 |
| 1.25 g/d n-3 | ln(CES-D) | Baseline (visit 1) | 1.5 scores on a scale | Standard Error 0.17 |
| 1.25 g/d n-3 | ln(CES-D) | Change, visit 1 to 5 | -0.29 scores on a scale | Standard Error 0.15 |
| 2.5 g/d n-3 | ln(CES-D) | Baseline (visit 1) | 1.6 scores on a scale | Standard Error 0.17 |
| 2.5 g/d n-3 | ln(CES-D) | Change, visit 1 to 5 | -0.26 scores on a scale | Standard Error 0.15 |
Comparison: Comparison was made on the change from baseline to 4 months.p-value: 0.895% CI: [-0.64, 0.18]Mixed Models Analysis
Comparison: Comparison was made on the change from baseline to 4 months.p-value: 195% CI: [-0.61, 0.21]Mixed Models Analysis
Primary
Serum ln(IL-6)
log-transformed serum Interleukin-6 (IL-6)
Time frame: Baseline & 4 months
Population: intention to treat
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum ln(IL-6) | Baseline (visit 1) | 0.91 pg/ml (raw IL-6) | Standard Error 0.6 |
| Placebo | Serum ln(IL-6) | Change, Visit 1 to 5 | 0.31 pg/ml (raw IL-6) | Standard Error 0.077 |
| 1.25 g/d n-3 | Serum ln(IL-6) | Baseline (visit 1) | 1.02 pg/ml (raw IL-6) | Standard Error 0.6 |
| 1.25 g/d n-3 | Serum ln(IL-6) | Change, Visit 1 to 5 | -0.106 pg/ml (raw IL-6) | Standard Error 0.07 |
| 2.5 g/d n-3 | Serum ln(IL-6) | Change, Visit 1 to 5 | -0.123 pg/ml (raw IL-6) | Standard Error 0.074 |
| 2.5 g/d n-3 | Serum ln(IL-6) | Baseline (visit 1) | 0.85 pg/ml (raw IL-6) | Standard Error 0.6 |
Comparison: Comparison was made on change from baseline to 4 months.p-value: 0.000395% CI: [-0.62, -0.21]Mixed Models Analysis
Comparison: Comparison was made on the change from baseline to 4 months.p-value: 0.000295% CI: [-0.64, -0.22]Mixed Models Analysis
Primary
Serum ln(TNF-a)
log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)
Time frame: Baseline & 4 months
Population: intention to treat
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum ln(TNF-a) | Baseline (visit 1) | 0.66 pg/ml (raw TNF-a) | Standard Error 0.25 |
| Placebo | Serum ln(TNF-a) | Change, Visit 1 to 5 | 0.11 pg/ml (raw TNF-a) | Standard Error 0.03 |
| 1.25 g/d n-3 | Serum ln(TNF-a) | Baseline (visit 1) | 0.74 pg/ml (raw TNF-a) | Standard Error 0.25 |
| 1.25 g/d n-3 | Serum ln(TNF-a) | Change, Visit 1 to 5 | 0.002 pg/ml (raw TNF-a) | Standard Error 0.028 |
| 2.5 g/d n-3 | Serum ln(TNF-a) | Baseline (visit 1) | 0.71 pg/ml (raw TNF-a) | Standard Error 0.25 |
| 2.5 g/d n-3 | Serum ln(TNF-a) | Change, Visit 1 to 5 | -0.024 pg/ml (raw TNF-a) | Standard Error 0.029 |
Comparison: Comparison was made on change from baseline to 4 monthsp-value: 0.0395% CI: [-0.19, -0.028]Mixed Models Analysis
Comparison: Comparison was made on the change from baseline to 4 months.p-value: 0.00495% CI: [-0.22, -0.052]Mixed Models Analysis