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Effect of Fish Oil on Plasma Triglycerides in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 4, 2008
First Posted Date  ICMJE December 8, 2008
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE December 2008
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2008)
Plasma Triglycerides
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2008)
LDL particle size
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Fish Oil on Plasma Triglycerides in Adults
Official Title  ICMJE Effect of Fish Oil as an Ethyl Ester or Triglyceride Preparation on Plasma Triglycerides in Hypertriglyceridemic Adults
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hypertriglyceridemia
Intervention  ICMJE
  • Dietary Supplement: Fish oil (90% triglycerides)
  • Dietary Supplement: Fish oil (60% triglycerides)
  • Dietary Supplement: Fish oil (ethyl esters)
  • Dietary Supplement: Soy oil
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Dietary Supplement: Soy oil
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2010)
60
Original Enrollment  ICMJE
 (submitted: December 4, 2008)
30
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00804427
Other Study ID Numbers  ICMJE SU-12042008-1358
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christopher Gardner, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Nordic Naturals
Investigators  ICMJE
Principal Investigator: Christopher D Gardner Stanford University
PRS Account Stanford University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP