Effect of Fish Oil on Plasma Triglycerides in Adults

This study has been completed.
Sponsor:
Collaborator:
Nordic Naturals
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00804427
First received: December 4, 2008
Last updated: May 21, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Hypertriglyceridemia
Behavioral: Dietary Supplement: Fish Oil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Plasma Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • LDL particle size [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: December 2008
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Eligibility is first determined through a telephone screen or an on-line screening tool. Those potential subjects who meet the eligibility criteria over the telephone or on-line will be required to make two clinic visits to the GCRC and provide two blood samples within a 1-week window, which will be used to determine further eligibility. Those who are still eligible after the blood analyses will be invited to attend a group orientation session.

The rationale for the study and the entire protocol will be discussed at the group orientations, which will be held approximately twice/month. Informed consent will be obtained after all questions are answered.

Those who signed the informed consent will be randomized in blocks of 10 (3/assignment group: fish oil in triglyceride form, fish oil as ethyl ester, and placebo).

Baseline measurements will include:

Blood sampling (twice within a 1-week window) Questionnaires (specifically dietary assessment questionnaire)

The same assessments will be collected 12 weeks after randomization. An additional blood sample will be collected at 4 and 8 weeks. Four-week supplies of study tablets will be distributed at baseline and at weeks 4 and 8.

Blood sampling will be done at the General Clinical Research Center/CTRU by trained nurses.

All of the study procedures involve minimal or negligible risk.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Christopher D Gardner, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00804427     History of Changes
Other Study ID Numbers: SU-12042008-1358
Study First Received: December 4, 2008
Last Updated: May 21, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 11, 2014