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Effect of Fish Oil on Plasma Triglycerides in Adults

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ClinicalTrials.gov Identifier: NCT00804427
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Nordic Naturals
Information provided by (Responsible Party):
Christopher Gardner, Stanford University

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.

Condition or disease Intervention/treatment
Hypertriglyceridemia 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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Fish Oil as an Ethyl Ester or Triglyceride Preparation on Plasma Triglycerides in Hypertriglyceridemic Adults
Study Start Date : December 2008
Primary Completion Date : February 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
Drug Information available for: Fish oil
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Change from baseline in Triglycerides at 3 months [ Time Frame: Baseline and 3 months ]
    Change was calculated as the value at 3 months minus the value at baseline


Secondary Outcome Measures :
  1. Change from baseline in LDL particle concentration (LDL1, LDL2, LDL3, LDL4) at 3 months [ Time Frame: Baseline and 3 months ]
    Change was calculated as the value at 3 months minus the value at baseline

  2. Change from baseline in LDL phenotype pattern (A, B, or A/B) at 3 months [ Time Frame: Baseline and 3 months ]
    Change was calculated as the number (and percent) of participants who improved their LDL phenotype pattern at 3 months.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804427


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Nordic Naturals
Investigators
Principal Investigator: Christopher D Gardner Stanford University

Additional Information:
Publications:
Responsible Party: Christopher Gardner, Professor of Medicine (Research), Stanford University
ClinicalTrials.gov Identifier: NCT00804427     History of Changes
Other Study ID Numbers: SU-12042008-1358
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christopher Gardner, Stanford University:
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:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases