Clinical trial NCT00804427: Effect of Fish Oil on Plasma Triglycerides in Adults
Official title: Effect of Fish Oil as an Ethyl Ester or Triglyceride Preparation on Plasma Triglycerides in Hypertriglyceridemic Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemia
Keywords: Fish oil
Triglycerides
Low-density Lipoprotein (LDL) cholesterol
Low-density Lipoprotein (LDL) subclass
Low-density Lipoprotein (LDL) particle size
Low-density Lipoprotein (LDL) phenotype
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Nordic Naturals
First posted: 2008-12-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in Triglycerides at 3 months
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change from baseline in LDL particle concentration (LDL1, LDL2, LDL3, LDL4) at 3 months
timeFrame: Baseline and 3 months
measure: Change from baseline in LDL phenotype pattern (A, B, or A/B) at 3 months
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Christopher D Gardner
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.