Effect of Fish Oil on Plasma Triglycerides in Adults

Stanford University60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Hypertriglyceridemia

Interventions

Fish oil (90% triglycerides)DIETARY_SUPPLEMENT

Fish oil (60% triglycerides)DIETARY_SUPPLEMENT

Fish oil (ethyl esters)DIETARY_SUPPLEMENT

Soy oilDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

Change from baseline in Triglycerides at 3 months

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

Time frame: Baseline and 3 months

Secondary Outcomes

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

Time frame: 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.

Time frame: Baseline and 3 months

Data from ClinicalTrials.gov

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