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| Name | Class |
|---|---|
| United States Department of Agriculture (USDA) | FED |
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The purpose of this study is to determine the lowest effective dose of EPA + DHA (300, 600, 900 and 1,800 mg/day delivered as fish oil supplements) that significantly attenuates the inflammatory response to in vivo and ex vivo endotoxin challenge as measured by the production over time of several inflammatory markers.
Inflammation is an important biological process initiated by the immune system in response to injury, irritation or infection. Prolonged or chronic inflammation is involved in the etiology of several diseases such as cardiovascular disease (CVD), diabetes, rheumatoid arthritis, cancer, and neurodegenerative diseases such as Alzheimer disease. The evidence base clearly demonstrates benefits of diet in ameliorating inflammation and reducing the burden of chronic disease. With respect to marine-derived omega-3 fatty acids and various markers of inflammation related to cardiovascular disease (CVD), both population studies and randomized controlled supplementation trials have yielded mixed results.
Some studies have demonstrated a dose-response relationship between dietary eicosapentaenoic acid and docosahexaenoic acid (EPA + DHA) and increased membrane (phospholipid) EPA and DHA. Red blood cell (RBC) EPA + DHA content has been proposed as a potential, modifiable marker for coronary heart disease (CHD) risk. It is well established that these fatty acids are precursors of series-3 prostanoids, thromboxanes, 5-series leukotrienes, and novel lipid mediators such as resolvins and protectins that have anti-inflammatory effects. We hypothesize that nutritionally-relevant intakes of omega-3 fatty acids are able to blunt the usual response to an inflammatory stimulus. We propose to test this hypothesis using both in vivo (i.v. endotoxin challenge) and ex vivo (endotoxin-stimulated monocytes) models in a 6-month, dose-response study with marine-derived omega-3 fatty acid supplements in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 300mg Fish Oil (EPA + DHA) Supplement | Experimental |
| |
| 600mg Fish Oil (EPA+DHA) Supplement | Experimental |
| |
| 900mg Fish Oil (EPA + DHA) Supplement | Experimental |
| |
| 1800mg Fish Oil (EPA + DHA) Supplement | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) | Biological | Comparison of 4 doses of EPA+DHA on in vivo and ex vivo (monocytes) response to an inflammatory stimulus (endotoxin) following a 6 month supplementation period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment | 5 months | |
| Mean Concentrations of CRP Following 5 Months of Treatment | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lipid Mediators | 0 Participants Analyzed; Lipid mediators were unable to be detected therefore there are no data to report. | 1, 2, 3 and 5 days post LPS administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gordon L Jensen, MD, PhD | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State University | University Park | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24252845 | Derived | Flock MR, Skulas-Ray AC, Harris WS, Etherton TD, Fleming JA, Kris-Etherton PM. Determinants of erythrocyte omega-3 fatty acid content in response to fish oil supplementation: a dose-response randomized controlled trial. J Am Heart Assoc. 2013 Nov 19;2(6):e000513. doi: 10.1161/JAHA.113.000513. |
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A computer-generated randomization scheme was developed in advance. The randomization scheme was stratified by sex and age and used a balanced block size of 5 to ensure even distribution among treatment groups. Using this randomization scheme, eligible participants were assigned to blinded treatments at the baseline visit by the study coordinator.
Recruitment and screened occured between September 2011 and March 2012 at the Clinical Research Center at Penn State University.
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| ID | Title | Description |
|---|---|---|
| FG000 | 300mg Fish Oil (EPA + DHA) Supplement | Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period |
| FG001 | 600mg Fish Oil (EPA+DHA) Supplement | Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period |
| FG002 | 900mg Fish Oil (EPA + DHA) Supplement | Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period |
| FG003 | 1800mg Fish Oil (EPA + DHA) Supplement | Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period |
| FG004 | Placebo | Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 300mg Fish Oil (EPA + DHA) Supplement | Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period |
| BG001 | 600mg Fish Oil (EPA+DHA) Supplement |
| 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 | Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment | One individual was removed from the analysis due to having very high RBC EPA+DHA content at study entry (>8%) | Posted | Mean | 95% Confidence Interval | pg/mL | 5 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 | 300 mg/d EPA + DHA (Fish Oil) Supplement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Penny Kris-Etherton | The Pennsylvania State University | 814-863-2923 | pmk3@psu.edu |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015118 | Eicosapentaenoic Acid |
| D004281 | Docosahexaenoic Acids |
| D015525 | Fatty Acids, Omega-3 |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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|
Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
| BG002 | 900mg Fish Oil (EPA + DHA) Supplement | Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 65 month supplementation period |
| BG003 | 1800mg Fish Oil (EPA + DHA) Supplement | Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period |
| BG004 | Placebo | Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG004 | Placebo |
|
|
| Primary | Mean Concentrations of CRP Following 5 Months of Treatment | One individual was removed from the analysis due to having very high RBC EPA+DHA content at study entry (>8%) | Posted | Mean | 95% Confidence Interval | mg/dL | 5 months |
|
|
|
| Secondary | Change in Lipid Mediators | 0 Participants Analyzed; Lipid mediators were unable to be detected therefore there are no data to report. | Lipid mediators were unable to be detected; Data were not collected. | Posted | 1, 2, 3 and 5 days post LPS administration |
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | 600 mg/d EPA + DHA (Fish Oil) Supplement | 0 | 21 | 0 | 21 |
| EG002 | 900 mg/d EPA + DHA (Fish Oil) Supplement | 0 | 24 | 0 | 24 |
| EG003 | 1800 mg/d EPA + DHA (Fish Oil) Supplement | 0 | 24 | 0 | 24 |
| EG004 | 0 mg/d EPA + DHA (Placebo) | 0 | 23 | 0 | 23 |
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| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |