Effect of Fish Oil as an Ethyl Ester or Triglyceride Preparation on Plasma Triglycerides in Hypertriglyceridemic Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline in Triglycerides at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •*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.
排除标准
- •*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
- •Pregnant or Lactating
- •Inability to communicate effectively with study personnel
结局指标
主要结局
Change from baseline in Triglycerides at 3 months
时间窗: Baseline and 3 months
Change was calculated as the value at 3 months minus the value at baseline
次要结局
- Change from baseline in LDL particle concentration (LDL1, LDL2, LDL3, LDL4) at 3 months(Baseline and 3 months)
- Change from baseline in LDL phenotype pattern (A, B, or A/B) at 3 months(Baseline and 3 months)
研究者
Christopher Gardner
Professor of Medicine (Research)
Stanford University