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| Name | Class |
|---|---|
| Nordic Naturals | INDUSTRY |
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The purpose of this small, short pilot study is to determine the feasibility (e.g., recruitment, dose acceptance, retention) of a future longer trial comparing the effects of two types of omega-3 fats from fish oil on plasma triglycerides. The two types of fish oil are composed of (1) omega-3 fatty acids in triglyceride form; and (2) as esterified free fatty acids (i.e. ethyl esters). Although these two types of fish oil supplements are available to the public, it remains unclear whether they are equally effective in lowering plasma triglycerides.
This study is a double-blinded, parallel design, placebo controlled trial with three active treatment arms to compare the triglyceride (TG) lowering effects of the same dose of EPA and DHA provided in three formulations of supplements that differ in the proportion of omega-3 FA present as ethyl esters vs. triglycerides. The active therapy for each of the three fish oil supplementation arms is 4 g/day of combined EPA and DHA provided as: a) 90% TG formulation, b) 60% TG formulation, or c) ethyl esters (esterified fatty acids)(i.e., 0% TG). The placebo was a soy oil supplement with an identical total fat content. The primary outcome is the 12-week change in TG concentrations in the active groups vs. placebo. Secondary outcomes include LDL particle distribution, defined as either subclasses LDL1, LDL2, LDL3 and LDL4, and LDL subclass phenotype patterns A, B, or A/B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish oil (90% triglycerides) | Experimental | Fish oil (4 grams/day of combined EPA and DHA) as 90% triglyceride formulation, taken in two divided doses with main meals. |
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| Fish oil (60% triglycerides) | Experimental | Fish oil (4 grams/day of combined EPA and DHA) as 60% triglyceride formulation, taken in two divided doses with main meals. |
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| Fish oil (ethyl esters) | Experimental | Fish oil (4 grams/day of combined EPA and DHA) as ethyl esters formulation (0% triglycerides), taken in two divided doses with main meals. |
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| Soy oil | Placebo Comparator | Soy oil supplement with identical total fat content, taken in two divided doses with main meals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish oil (90% triglycerides) | Dietary Supplement |
| ||
| Fish oil (60% triglycerides) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Triglycerides at 3 months | Change was calculated as the value at 3 months minus the value at baseline | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in LDL particle concentration (LDL1, LDL2, LDL3, LDL4) at 3 months | Change was calculated as the value at 3 months minus the value at baseline | Baseline and 3 months |
| Change from baseline in LDL phenotype pattern (A, B, or A/B) at 3 months |
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Inclusion Criteria:*Gender: Both women and men
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| Name | Affiliation | Role |
|---|---|---|
| Christopher D Gardner | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21924882 | Result | Oelrich B, Dewell A, Gardner CD. Effect of fish oil supplementation on serum triglycerides, LDL cholesterol and LDL subfractions in hypertriglyceridemic adults. Nutr Metab Cardiovasc Dis. 2013 Apr;23(4):350-7. doi: 10.1016/j.numecd.2011.06.003. Epub 2011 Sep 15. |
| Label | URL |
|---|---|
| Description of study and summary of results | View source |
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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 |
|---|---|
| D005395 | Fish Oils |
| D014280 | Triglycerides |
| D013024 | Soybean Oil |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D005989 | Glycerides |
| D004042 | Dietary Fats, Unsaturated |
| D004041 |
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| Dietary Supplement |
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| Fish oil (ethyl esters) | Dietary Supplement |
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| Soy oil | Dietary Supplement |
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Change was calculated as the number (and percent) of participants who improved their LDL phenotype pattern at 3 months. |
| Baseline and 3 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| Dietary Fats |
| 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 |