Trial | NCT00804427  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fish oil ...

  • Study Participants

    60
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.
Study Started
Dec 31
2008
Primary Completion
Feb 28
2010
Study Completion
Apr 30
2010
Last Update
Feb 22
2023

Dietary Supplement Fish oil (90% triglycerides)

Dietary Supplement Fish oil (60% triglycerides)

Dietary Supplement Fish oil (ethyl esters)

Dietary Supplement Soy oil

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.

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.

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.

Soy oil Placebo Comparator

Soy oil supplement with identical total fat content, taken in two divided doses with main meals.

Criteria 

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
No Results Posted