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Completed

NCT Number: NCT00804427

Effect of Fish Oil on Plasma Triglycerides in Adults

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.

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish oil (90% triglycerides)

Dietary Supplement

Fish oil (60% triglycerides)

Dietary Supplement

Fish oil (ethyl esters)

Dietary Supplement

Soy oil

Dietary Supplement

Primary outcomes

  1. Change from baseline in Triglycerides at 3 months

    Time frame: Baseline and 3 months

    Change was calculated as the value at 3 months minus the value at baseline

Secondary outcomes

  1. Change from baseline in LDL particle concentration (LDL1, LDL2, LDL3, LDL4) at 3 months

    Time frame: Baseline and 3 months

    Change was calculated as the value at 3 months minus the value at baseline

  2. Change from baseline in LDL phenotype pattern (A, B, or A/B) at 3 months

    Time frame: Baseline and 3 months

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Nordic Naturals

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 8, 2008
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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