Effect of Fish Oil on Plasma Triglycerides in 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 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|
- Plasma Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- LDL particle size [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
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.
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Christopher D Gardner||Stanford University|