Effect of Fish Oil on Plasma Triglycerides in Adults

Hypertriglyceridemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804427
• Other study ID #: SU-12042008-1358
• Status: Completed
• Phase: N/A
• Start date: December 2008
• Est. completion date: April 2010

Study information

• Verified date: February 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Dietary Supplement:
• Fish oil (90% triglycerides)

• Fish oil (60% triglycerides)

• Fish oil (ethyl esters)

• Soy oil

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Nordic Naturals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Triglycerides at 3 months	Change was calculated as the value at 3 months minus the value at baseline	Baseline and 3 months
Secondary	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	Baseline and 3 months
Secondary	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.	Baseline and 3 months

External Links

•   Description of study and summary of results