Effect of Fish Oil on Plasma Triglycerides in Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Fish Oil as an Ethyl Ester or Triglyceride Preparation on Plasma Triglycerides in Hypertriglyceridemic Adults

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Dietary Supplement: Fish oil (90% triglycerides)
* Dietary Supplement: Fish oil (60% triglycerides)
* Dietary Supplement: Fish oil (ethyl esters)
* Dietary Supplement: Soy oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:*Gender: Both women and men Age: > or = 18 years Ethnicity and race: All ethnic and racial backgrounds welcome Fasting blood triglycerides greater than or equal to 150 mg/dL Planning to be available for clinic visits for the 12 weeks of study participation Ability and willingness to give written informed consent No known active psychiatric illness. Exclusion Criteria:*At screening: Daily intake of dietary supplements containing omega-3 FAs within the past month. Fasting blood glucose greater than or equal to 126 mg/dL Self reported personal history of: Clinically significant atherosclerosis (e.g., CAD, PAD) Malignant neoplasm Subjects currently receiving the following medications (self report): Lipid lowering drugs including statins Anti-hypertensive drugs: beta-blockers and thiazides Body Mass Index (BMI) greater than or equal to 40. Pregnant or Lactating Inability to communicate effectively with study personnel

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oil (90% triglycerides)<br>Fish oil (4 grams/day of combined EPA and DHA) as 90% triglyceride formulation, taken in two divided doses with main meals. | Dietary Supplement: Fish oil (90% triglycerides)<br> <br> |
| Experimental: Fish oil (60% triglycerides)<br>Fish oil (4 grams/day of combined EPA and DHA) as 60% triglyceride formulation, taken in two divided doses with main meals. | Dietary Supplement: Fish oil (60% triglycerides)<br> <br> |
| Experimental: Fish oil (ethyl esters)<br>Fish oil (4 grams/day of combined EPA and DHA) as ethyl esters formulation (0% triglycerides), taken in two divided doses with main meals. | Dietary Supplement: Fish oil (ethyl esters)<br> <br> |
| Placebo Comparator: Soy oil<br>Soy oil supplement with identical total fat content, taken in two divided doses with main meals. | Dietary Supplement: Soy oil<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Change was calculated as the number (and percent) of participants who improved their LDL phenotype pattern at 3 months. | Baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fish oil, Triglycerides, Low-density Lipoprotein (LDL) cholesterol, Low-density Lipoprotein (LDL) subclass, Low-density Lipoprotein (LDL) particle size, Low-density Lipoprotein (LDL) phenotype