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

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.

Study Overview

• Status: Completed
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Dietary supplement: Fish oil (90% triglycerides); Dietary supplement: Fish oil (60% triglycerides); Dietary supplement: Fish oil (ethyl esters); Dietary supplement: Soy oil

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fish oil (90% triglycerides); Fish oil (4 grams/day of combined EPA and DHA) as 90% triglyceride formulation, taken in two divided doses with main meals.	Dietary supplement: Fish oil (90% triglycerides)
Experimental: Fish oil (60% triglycerides); Fish oil (4 grams/day of combined EPA and DHA) as 60% triglyceride formulation, taken in two divided doses with main meals.	Dietary supplement: Fish oil (60% triglycerides)
Experimental: Fish oil (ethyl esters); Fish oil (4 grams/day of combined EPA and DHA) as ethyl esters formulation (0% triglycerides), taken in two divided doses with main meals.	Dietary supplement: Fish oil (ethyl esters)
Placebo Comparator: Soy oil; Soy oil supplement with identical total fat content, taken in two divided doses with main meals.	Dietary supplement: Soy oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Nordic Naturals

Publications and helpful links

General Publications

• 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.

Helpful Links

• Description of study and summary of results

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: December 4, 2008
• First Submitted That Met QC Criteria: December 4, 2008
• First Posted (Estimate): December 8, 2008

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia
• Other Study ID Numbers: SU-12042008-1358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No