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| ID | Type | Description | Link |
|---|---|---|---|
| 2006H0054 | |||
| R01AG029562 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This study is designed to examine the effects of fish oil on immune function and mood.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 1.25 g/d |
|
| 2 | Experimental | 2.496 g/d |
|
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega 3 (Fish Oil) Supplementation | Dietary Supplement | 1.25 g or 2.496 g daily for 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum ln(TNF-a) | log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha) | Baseline & 4 months |
| Serum ln(IL-6) | log-transformed serum Interleukin-6 (IL-6) | Baseline & 4 months |
| 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. | Baseline & 4 months |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janice K. Kiecolt-Glaser | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22640930 | Result | Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Hwang BS, Glaser R. Omega-3 supplementation lowers inflammation in healthy middle-aged and older adults: a randomized controlled trial. Brain Behav Immun. 2012 Aug;26(6):988-95. doi: 10.1016/j.bbi.2012.05.011. Epub 2012 May 26. | |
| 23010452 | Result | Kiecolt-Glaser JK, Epel ES, Belury MA, Andridge R, Lin J, Glaser R, Malarkey WB, Hwang BS, Blackburn E. Omega-3 fatty acids, oxidative stress, and leukocyte telomere length: A randomized controlled trial. Brain Behav Immun. 2013 Feb;28:16-24. doi: 10.1016/j.bbi.2012.09.004. Epub 2012 Sep 23. |
| 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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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo : matching placebo capsule daily for 4 months |
| FG001 | 1.25 g/d n-3 | Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months |
| FG002 | 2.5 g/d n-3 | Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo : matching placebo capsule daily for 4 months |
| BG001 | 1.25 g/d n-3 | Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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(TNF-a) | log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha) | intention to treat | Posted | Least Squares Mean | Standard Error | pg/ml (raw TNF-a) | Baseline & 4 months |
|
4 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 : matching placebo capsule daily for 4 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear ache | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Janice K. Kiecolt-Glaser | Institute for Behavioral Medicine Research, Ohio State University College of Medicine, OH, USA | +1 614 293 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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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D005395 | Fish Oils |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Placebo | Dietary Supplement | matching placebo capsule daily for 4 months |
|
| 33875799 | Derived | Madison AA, Belury MA, Andridge R, Renna ME, Rosie Shrout M, Malarkey WB, Lin J, Epel ES, Kiecolt-Glaser JK. Omega-3 supplementation and stress reactivity of cellular aging biomarkers: an ancillary substudy of a randomized, controlled trial in midlife adults. Mol Psychiatry. 2021 Jul;26(7):3034-3042. doi: 10.1038/s41380-021-01077-2. Epub 2021 Apr 20. |
| 25264972 | Derived | Jaremka LM, Derry HM, Bornstein R, Prakash RS, Peng J, Belury MA, Andridge RR, Malarkey WB, Kiecolt-Glaser JK. Omega-3 supplementation and loneliness-related memory problems: secondary analyses of a randomized controlled trial. Psychosom Med. 2014 Oct;76(8):650-8. doi: 10.1097/PSY.0000000000000104. |
| BG002 | 2.5 g/d n-3 | Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Sagittal abdominal diameter | Mean | Standard Deviation | cm |
|
| CES-D | 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. | Median | Inter-Quartile Range | scores on a scale |
|
|
|
|
| Primary | Serum ln(IL-6) | log-transformed serum Interleukin-6 (IL-6) | intention to treat | Posted | Least Squares Mean | Standard Error | pg/ml (raw IL-6) | Baseline & 4 months |
|
|
|
|
| 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. | intention to treat | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline & 4 months |
|
|
|
|
| 0 |
| 46 |
| 42 |
| 46 |
| EG001 | 1.25 g/d n-3 | Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months | 0 | 46 | 38 | 46 |
| EG002 | 2.5 g/d n-3 | Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months | 0 | 46 | 40 | 46 |
| Sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Swollen glands | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Stuffy nose | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Wheeze | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dry cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Wet cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
|
Comparison was made on the change from baseline to 4 months. |
| Mixed Models Analysis |
| 0.0002 |
Bonferroni-adjusted to account for multiple testing. |
| Difference in change from baseline |
| -0.43 |
| Standard Error of the Mean |
| 0.11 |
| 2-Sided |
| 95 |
| -0.64 |
| -0.22 |
2.5 g/d minus placebo |
| No |
| Superiority or Other |
|
Comparison was made on the change from baseline to 4 months. |
| Mixed Models Analysis |
| 1.0 |
Bonferroni-adjusted to account for multiple testing. |
| Difference in change from baseline |
| -0.20 |
| Standard Error of the Mean |
| 0.21 |
| 2-Sided |
| 95 |
| -0.61 |
| 0.21 |
2.5 g/d minus placebo |
| No |
| Superiority or Other |