Effect of Fish Oil on Plasma Triglycerides in Adults

Stanford University

Status: Completed

Conditions: Hypertriglyceridemia

Treatments: Dietary Supplement: Fish oil (90% triglycerides); Dietary Supplement: Fish oil (ethyl esters); Dietary Supplement: Soy oil; Dietary Supplement: Fish oil (60% triglycerides)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00804427

SU-12042008-1358

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

Fish oil (90% triglycerides)

Experimental group

Description:

Fish oil (4 grams/day of combined EPA and DHA) as 90% triglyceride formulation, taken in two divided doses with main meals.

Treatment:

Dietary Supplement: Fish oil (90% triglycerides)

Fish oil (60% triglycerides)

Experimental group

Description:

Fish oil (4 grams/day of combined EPA and DHA) as 60% triglyceride formulation, taken in two divided doses with main meals.

Treatment:

Dietary Supplement: Fish oil (60% triglycerides)

Fish oil (ethyl esters)

Experimental group

Description:

Fish oil (4 grams/day of combined EPA and DHA) as ethyl esters formulation (0% triglycerides), taken in two divided doses with main meals.

Treatment:

Dietary Supplement: Fish oil (ethyl esters)

Soy oil

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Soy oil