A Parallel Bioavailability Study of Fish Oil-Ethyl Ester Versus Fish Oil-Triglyceride Versus Krill Oil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 主要终点
- Comparison of total plasma DHA+EPA levels across 3 treatment groups
研究概览
简要总结
A multiple-dose, double-blind, randomized, four-week, three-treatment, parallel study in which 66 healthy adult subjects will receive 6 capsules/d, administered as a dose of 1.3 g/d eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) in fish oil ethyl ester (EE), or fish oil triglyceride (TG) or krill oil for a total of 4 weeks. The objective of the study is to compare the oral bioavailability of EPA+DHA in total plasma across the three formulations at the end of the 4 week study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult female who is neither pregnant nor breastfeeding, or
- •a healthy, adult male
- •with a body mass index (BMI) between 18 and 30 kg/m2 (inclusive), and
- •with a minimum weight of 50 kg (110 lbs).
排除标准
- •history or presence of diabetes, high triglycerides (≥240 mg/dL), or high cholesterol (≥240 mg/dL);
- •clinically significant abnormal finding on the physical exam, medical history, vital signs, or clinical laboratory results at screening;
- •history or presence of allergic response to omega-3-fatty acids or sensitivity or allergy to fish or shellfish;
- •history of coagulation disorder or current anticoagulation therapy;
- •has used any nutritional supplements, omega-3 supplements, fish oil, chia, krill oil, flaxseed or foods supplemented with omega-3s within 3 months prior to the first dose of study medication;
- •has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
研究组 & 干预措施
fish oil ethyl ester
1.3g/d dose of DHA+EPA in fish oil EE (6 capsules) administered for 4 weeks
干预措施: fish oil ethyl ester (Dietary Supplement)
fish oil triglyceride
1.3g/d dose of DHA+EPA in fish oil TG (6 capsules) administered for 4 weeks
干预措施: fish oil triglyceride (Dietary Supplement)
krill oil
1.3g/d dose of DHA+EPA in krill oil (6 capsules) administered for 4 weeks
干预措施: krill oil (Dietary Supplement)
结局指标
主要结局
Comparison of total plasma DHA+EPA levels across 3 treatment groups
时间窗: 4 weeks
次要结局
- pharmacokinetic parameter: AUC to 672hr(4 weeks)
- Comparison of RBC DHA+EPA levels across 3 treatment groups(4 weeks)
- pharmacokinetic parameter: Tmax(4 weeks)
- pharmacokinetic parameter: Cmax(4 weeks)
- pharmacokinetic parameter: AUC to 336hr(2 weeks)