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| Name | Class |
|---|---|
| Reliant Pharmaceuticals | INDUSTRY |
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The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of an omega-3 fatty acid concentrate in a group of people who normally are not treated for high lipids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4g P-OM3, then 1g P-OM3, then Placebo | Experimental | 4 g/day Dose Prescription Omega-3 acid ethyl esters (P-OM3)capsules(4) for first intervention (8 weeks), followed by 1g/day P-OM3 capsules(4) for 2nd intervention (8 weeks), followed by Placebo corn oil capsules, 4/day, for the 3rd intervention (8 weeks). |
|
| 1g P-OM3, then 4g P-OM3, then Placebo | Experimental | 1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks,followed by 6-wk washout. Placebo capsules for 8-wks. |
|
| Placebo, then 4g P-OM3, then 1g P-OM3 | Experimental | Corn Oil placebo capsules for 8-wks, followed by 6-wk washout. 4g P-OM3 capsules for 8-wks, followed by 6-wk washout. 1g P-OM3 for 8-wks. |
|
| 4g P-OM3, then Placebo, then 1g P-OM3 | Experimental | 4g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 1g capsules for 8 wks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4/day of 4g P-OM3 capsules | Drug | 4/day of 4g P-OM3 capsules for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lipid Profile | Plasma/serum samples were analyzed at baseline and at the end of each 8-week treatment period to evaluate the effect of P-OM3 dose on triglycerides, HDL-C, LDL-C, and total cholesterol. | 8 weeks |
| Flow-mediated Dilation (FMD) | Effect of P-OM3 dose on FMD, which is measured as percent change in brachial artery diameter at peak dilation vs. baseline following a 5-minute occlusion period. | 8 weeks |
| Blood Pressure | Effect of P-OM3 dose on blood pressure | 8 weeks |
| Heart Rate | Effect of P-OM3 dose on heart rate | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Erythrocyte Fatty Acids | Effect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells | 8 weeks |
| Cytokine Inflammatory Markers | Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheila G West, PhD | Penn State University | Principal Investigator |
| Penny M Kris-Etherton, PhD | Penn State University | Principal Investigator |
| Ann C Skulas-Ray, B.S. | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State University General Clinical Research Center | University Park | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23592752 | Derived | Sauder KA, Skulas-Ray AC, Campbell TS, Johnson JA, Kris-Etherton PM, West SG. Effects of omega-3 fatty acid supplementation on heart rate variability at rest and during acute stress in adults with moderate hypertriglyceridemia. Psychosom Med. 2013 May;75(4):382-9. doi: 10.1097/PSY.0b013e318290a107. Epub 2013 Apr 16. | |
| 22865498 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 4g P-OM3, Then 1g P-OM3, Then Placebo | 4 g/day Dose Prescription Omega-3 acid ethyl esters (P-OM3)capsules(4) for first intervention (8 weeks), followed by 1g/day P-OM3 capsules(4) for 2nd intervention (8 weeks), followed by Placebo corn oil capsules, 4/day, for the 3rd intervention (8 weeks) |
| FG001 | 1g P-OM3, Then 4g P-OM3, Then Placebo | 1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks,followed by 6-wk washout. Placebo capsules for 8-wks |
| FG002 | Placebo, Then 4g P-OM3, Then 1g P-OM3 | Corn Oil placebo capsules for 8-wks, followed by 6-wk washout. 4g P-OM3 capsules for 8-wks, followed by 6-wk washout. 1g P-OM3 for 8-wks |
| FG003 | 4g P-OM3, Then Placebo, Then 1g P-OM3 | 4g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 1g capsules for 8 wks |
| FG004 | 1g P-OM3, Then Placebo, Then 4g P-OM3 | 1g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks. |
| FG005 | Placebo, Then 1g P-OM3, Then 4g P-OM3 | Corn oil placebo capsules for 8-wks, followed by 6-wk washout.1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1 subject in the "Placebo, 4 g P-OM3, 1 g P-OM3" sequence and 1 subject in the "1 g P-OM3, Placebo, 4 g P-OM3" sequence did not complete the study and were not included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 g P-OM3, 1 g P-OM3, Placebo | 4 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 1 g/d P-OM3 for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks |
| BG001 | 1 g P-OM3, 4 g P-OM3, Placebo |
| 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 | Lipid Profile | Plasma/serum samples were analyzed at baseline and at the end of each 8-week treatment period to evaluate the effect of P-OM3 dose on triglycerides, HDL-C, LDL-C, and total cholesterol. | Posted | Mean | Standard Error | mg/dL | 8 weeks |
|
Adverse event data were collected while participants were enrolled (approximately 2.5 years).
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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 | 4g P-OM3 | 4 g Prescription Omega-3 acid ethyl esters (P-OM3) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal symptoms | Gastrointestinal disorders | Non-systematic Assessment | Lower GI symptoms that contributed to withdrawal from the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann Skulas-Ray | Penn State University | 814-863-0856 | aus164@psu.edu |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
| D005395 | Fish Oils |
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
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| 1g P-OM3, then Placebo, then 4g P-OM3 | Experimental | 1g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks. |
|
| Placebo, then 1g P-OM3, then 4g P-OM3 | Experimental | Corn oil placebo capsules for 8-wks, followed by 6-wk washout.1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks. |
|
|
| 4/day of 1g P-OM3 capsules | Drug | 4/day of 1g P-OM3 capsules for 8 weeks |
|
|
| Corn Oil Placebo, 4 capsules/day for 8 weeks | Drug | 4 capsules per day of corn oil placebo for 8 weeks |
|
|
| 8 weeks |
| Fasting Glucose | Effect of P-OM3 dose on fasting glucose | 8 weeks |
| Psychosocial Profile Questionnaires | Effect of P-OM3 dose on psychosocial questionnaires: Perceived Stress Scale (PSS)
Spielberger State Anxiety Inventory
Positive and Negative Affect Scales (PANAS)
Center for Epidemiologic Studies Depression (CES-D) Scale
| 8 weeks |
| C-reactive Protein (CRP) | Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP | 8 weeks |
| Fasting Insulin | Effect of P-OM3 dose on fasting insulin | 8 weeks |
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI) | Effect of P-OM3 dose on the homeostatic model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI). HOMA-IR calculates an index of insulin resistance and is calculated as follows: HOMA-IR = (glucose mg/dL * insulin mU/L) / 405. QUICKI is calculated as follows: QUICKI = 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). | 8 weeks |
| Skulas-Ray AC, Kris-Etherton PM, Harris WS, West SG. Effects of marine-derived omega-3 fatty acids on systemic hemodynamics at rest and during stress: a dose-response study. Ann Behav Med. 2012 Dec;44(3):301-8. doi: 10.1007/s12160-012-9393-2. |
| 21159789 | Derived | Skulas-Ray AC, Kris-Etherton PM, Harris WS, Vanden Heuvel JP, Wagner PR, West SG. Dose-response effects of omega-3 fatty acids on triglycerides, inflammation, and endothelial function in healthy persons with moderate hypertriglyceridemia. Am J Clin Nutr. 2011 Feb;93(2):243-52. doi: 10.3945/ajcn.110.003871. Epub 2010 Dec 15. |
| Withdrawal by Subject |
|
1 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d P-OM3 for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks
| BG002 | Placebo, 4 g P-OM3, 1 g P-OM3 | 4 g/d corn oil placebo for 8 weeks, followed by 4 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 1 g/d P-OM3 for 8 weeks |
| BG003 | 4 g P-OM3, Placebo, 1 g P-OM3 | 4 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks, followed by 1 g/d P-OM3 for 8 weeks |
| BG004 | 1 g P-OM3, Placebo, 4 g P-OM3 | 1 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d corn oil placebo for 8 weeks, followed by 4 g/d P-OM3 for 8 weeks |
| BG005 | Placebo, 1 g P-OM3, 4 g P-OM3 | 4 g/d corn oil placebo for 8 weeks, followed by 1 g/d prescription omega-3 fatty acid ethyl esters (P-OM3) for 8 weeks, followed by 4 g/d P-OM3 for 8 weeks |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Flow-mediated Dilation (FMD) | Effect of P-OM3 dose on FMD, which is measured as percent change in brachial artery diameter at peak dilation vs. baseline following a 5-minute occlusion period. | Posted | Mean | Standard Error | % change in brachial artery diameter | 8 weeks |
|
|
|
| Primary | Blood Pressure | Effect of P-OM3 dose on blood pressure | Two participants did not complete the study and were therefore excluded from analysis. | Posted | Mean | Standard Error | mm Hg | 8 weeks |
|
|
|
| Primary | Heart Rate | Effect of P-OM3 dose on heart rate | Posted | Mean | Standard Error | beats per minute | 8 weeks |
|
|
|
| Secondary | Erythrocyte Fatty Acids | Effect of P-OM3 dose on the percent concentration of select omega-3 fatty acids in red blood cells | Posted | Mean | Standard Error | percentage | 8 weeks |
|
|
|
| Secondary | Cytokine Inflammatory Markers | Effect of P-OM3 dose on concentrations of circulating inflammatory markers in plasma | Posted | Mean | Standard Error | pg/mL | 8 weeks |
|
|
|
| Secondary | Fasting Glucose | Effect of P-OM3 dose on fasting glucose | Posted | Mean | Standard Error | mg/dL | 8 weeks |
|
|
|
| Secondary | Psychosocial Profile Questionnaires | Effect of P-OM3 dose on psychosocial questionnaires: Perceived Stress Scale (PSS)
Spielberger State Anxiety Inventory
Positive and Negative Affect Scales (PANAS)
Center for Epidemiologic Studies Depression (CES-D) Scale
| Posted | Mean | Standard Error | scores on a scale | 8 weeks |
|
|
|
| Secondary | C-reactive Protein (CRP) | Effect of P-OM3 dose on the plasma concentration of the inflammatory marker CRP | Posted | Mean | Standard Error | mg/L | 8 weeks |
|
|
|
| Secondary | Fasting Insulin | Effect of P-OM3 dose on fasting insulin | Posted | Mean | Standard Error | μIU/mL | 8 weeks |
|
|
|
| Secondary | Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI) | Effect of P-OM3 dose on the homeostatic model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI). HOMA-IR calculates an index of insulin resistance and is calculated as follows: HOMA-IR = (glucose mg/dL * insulin mU/L) / 405. QUICKI is calculated as follows: QUICKI = 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). | Posted | Mean | Standard Error | index units | 8 weeks |
|
|
|
| 0 |
| 27 |
| 1 |
| 27 |
| EG001 | 1g P-OM3 | 1 g Prescription Omega-3 acid ethyl esters (P-OM3) | 0 | 27 | 0 | 27 |
| EG002 | Placebo | Corn oil placebo | 0 | 28 | 0 | 28 |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D005223 |
| Fats |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
|
|
| Omega-3 Index (EPA + DHA) |
|
|
| Tumor Necrosis Factor-α (TNF-α) |
|
|
| Negative Scale (PANAS) |
|
| CES-D |
|
| Spielberger State Anxiety Inventory |
|
|