Effect of Fish Oil on Plasma Triglycerides in Adults

Not Applicable

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Dietary Supplement: Fish oil (90% triglycerides); Dietary Supplement: Fish oil (60% triglycerides); Dietary Supplement: Fish oil (ethyl esters); Dietary Supplement: Soy oil

• Registration Number: NCT00804427
• Lead Sponsor: Stanford University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-04
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-08
• Primary Completion: 2010-02
• Study Completion: 2010-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish oil (90% triglycerides)	Fish oil (90% triglycerides)	Fish oil (4 grams/day of combined EPA and DHA) as 90% triglyceride formulation, taken in two divided doses with main meals.
Fish oil (60% triglycerides)	Fish oil (60% triglycerides)	Fish oil (4 grams/day of combined EPA and DHA) as 60% triglyceride formulation, taken in two divided doses with main meals.
Fish oil (ethyl esters)	Fish oil (ethyl esters)	Fish oil (4 grams/day of combined EPA and DHA) as ethyl esters formulation (0% triglycerides), taken in two divided doses with main meals.
Soy oil	Soy oil	Soy oil supplement with identical total fat content, taken in two divided doses with main meals.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Triglycerides at 3 months	Baseline and 3 months	Change was calculated as the value at 3 months minus the value at baseline

Secondary Outcome Measures

Name	Time	Method
Change from baseline in LDL particle concentration (LDL1, LDL2, LDL3, LDL4) at 3 months	Baseline and 3 months	Change was calculated as the value at 3 months minus the value at baseline
Change from baseline in LDL phenotype pattern (A, B, or A/B) at 3 months	Baseline and 3 months	Change was calculated as the number (and percent) of participants who improved their LDL phenotype pattern at 3 months.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States