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Effect of Fish Oil on Plasma Triglycerides in Adults

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fish oil (90% triglycerides)
Fish oil (60% triglycerides)
Fish oil (ethyl esters)
Soy oil
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertriglyceridemia focused on measuring Fish oil, Triglycerides, Low-density Lipoprotein (LDL) cholesterol, Low-density Lipoprotein (LDL) subclass, Low-density Lipoprotein (LDL) particle size, Low-density Lipoprotein (LDL) phenotype

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Fish oil (90% triglycerides)

Fish oil (60% triglycerides)

Fish oil (ethyl esters)

Soy oil

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Change from baseline in Triglycerides at 3 months
Change was calculated as the value at 3 months minus the value at baseline

Secondary Outcome Measures

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
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.

Full Information

First Posted
December 4, 2008
Last Updated
February 18, 2023
Sponsor
Stanford University
Collaborators
Nordic Naturals
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1. Study Identification

Unique Protocol Identification Number
NCT00804427
Brief Title
Effect of Fish Oil on Plasma Triglycerides in Adults
Official Title
Effect of Fish Oil as an Ethyl Ester or Triglyceride Preparation on Plasma Triglycerides in Hypertriglyceridemic Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Nordic Naturals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fish oil (90% triglycerides)
Arm Type
Experimental
Arm Description
Fish oil (4 grams/day of combined EPA and DHA) as 90% triglyceride formulation, taken in two divided doses with main meals.
Arm Title
Fish oil (60% triglycerides)
Arm Type
Experimental
Arm Description
Fish oil (4 grams/day of combined EPA and DHA) as 60% triglyceride formulation, taken in two divided doses with main meals.
Arm Title
Fish oil (ethyl esters)
Arm Type
Experimental
Arm 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.
Arm Title
Soy oil
Arm Type
Placebo Comparator
Arm Description
Soy oil supplement with identical total fat content, taken in two divided doses with main meals.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil (90% triglycerides)
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil (60% triglycerides)
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil (ethyl esters)
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy oil
Primary Outcome Measure Information:
Title
Change from baseline in Triglycerides at 3 months
Description
Change was calculated as the value at 3 months minus the value at baseline
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Change from baseline in LDL particle concentration (LDL1, LDL2, LDL3, LDL4) at 3 months
Description
Change was calculated as the value at 3 months minus the value at baseline
Time Frame
Baseline and 3 months
Title
Change from baseline in LDL phenotype pattern (A, B, or A/B) at 3 months
Description
Change was calculated as the number (and percent) of participants who improved their LDL phenotype pattern at 3 months.
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D Gardner
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21924882
Citation
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.
Results Reference
result
Links:
URL
https://med.stanford.edu/nutrition/research/completed-studies/fish-oil-and-triglycerides.html
Description
Description of study and summary of results

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Effect of Fish Oil on Plasma Triglycerides in Adults

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