Evaluation of the Biologic Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)-Enriched Oils (EPA-DHA Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- plasma EPA levels as well as the EPA/DHA ratio and plasma DHA levels as well as the DHA/EPA ratio
研究概览
简要总结
The goal of the study is to test the efficacy of an EPA-enriched oil made by DuPont versus a DHA-enriched oil, a standard fish oil preparation, and olive oil placebo in a double-blind, randomized, placebo-controlled trial. This study will compare the efficacy of 1800 mg/day of EPA versus 1800 mg/day of DHA versus a fish oil product containing 1800 mg of EPA and 1200 mg of DHA/day as compared to olive oil placebo at 6 grams/day over a 6 week period in a parallel arm design study of 120 healthy adults studied in both the fasting and post-prandial state. Safety will be monitored by assessing for adverse reactions, measuring vital signs and a variety of lab tests including a complete metabolic profile and complete blood count. Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios,as well as by measuring plasma lipids, lipoproteins, and markers of inflammation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or surgically sterile females between ages 21-
- •Body Mass Index of 20-
- •Plasma Lipoprotein Associated Phospholipase A2 (LpPLA2) values > 200 ng/ml.
排除标准
- •Competitive exerciser.
- •Current smoker.
- •Those already taking dietary supplements (EPA, DHA, flax seed oil, fish oil, cod liver oil, weight control products, or high doses of vitamin C (>500 mg/day) or vitamin E (>400 mg/day).
- •Those consuming more than 3 oily fish species/week.
- •Those consuming >2 drinks containing alcohol/day.
- •Those taking medications which could affect serum lipids or body weight, or taking coumadin or more than 325 mg/day of aspirin which could effect bleeding time or the coagulation profile.
- •History of a bleeding disorder.
- •History of significant cardiac, renal, hepatic, gastro-intestinal, pulmonary, neoplastic, biliary or endocrine disorders including uncontrolled diabetes, thyroid disease, or hypertension.
- •Plasma LpPLA2 values < 200 ng/ml.
结局指标
主要结局
plasma EPA levels as well as the EPA/DHA ratio and plasma DHA levels as well as the DHA/EPA ratio
时间窗: Six weeks
Subjects receiving EPA at 1800 mg/day will have significantly greater plasma EPA levels as well as the EPA/DHA ratio than the placebo group or the group receiving DHA, while the group receiving DHA will have significantly greater increases in plasma DHA levels as well as the DHA/EPA ratio than the placebo group or the group receiving EPA.
次要结局
- LpPLA2(6 weeks)