NCT02089165已完成2 期
Randomized, Single-center, Open-label, Blinded Endpoint Assessment Study (Cross-over Study With 3 Study Products) on Bioavailability of Fatty Acids (Plasma Lipid Fractions) From Krill Oil and Krill Meal and Fatty Acids From Fish Oil in Healthy Subjects.
Olympic Seafood AS2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma phospholipids.
研究概览
简要总结
The purpose of the study is to compare the acute bioavailability of two different krill oil products called krill oil and krill meal in comparison to fish oil product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female and male
- •Age 18 - 65 years
- •Body mass index 18.5 - 30
- •Informed consent, signed
排除标准
- •Medication potential to affect the bioavailability of fatty acids (e.g. lipid-lowering drugs)
- •Familial hypercholesterolemia, marked combined hyperlipidemia, condition that would impair, fat absorption (e.g. chronic pancreatitis, pancreatic lipase deficiency syndrome)
- •Any untreated medical condition affecting absorption of fat
- •Type 1 and 2 diabetes
- •Cancer or other malignant disease within past five years
- •Periodical hormone replacement therapy
- •High intake of oily fish (once a week or more) (i.e. salmon, herring, sardines, mackerel, vendace)
- •Alcohol consumption > 15 doses per week
- •Females who are pregnant, breast-feeding or intend to become pregnant
- •Hypersensitivity to any of the components of the test product
- •Regular use of n-3 supplements 4 weeks before randomization
- •Lack of suitability for participation in the trial, for any medical reason, as judged by the principal investigator
结局指标
主要结局
Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma phospholipids.
时间窗: 0-72 h
次要结局
- Incremental 0-72 h area under the curve of EPA + DHA proportion in plasma triglyceride.(0-72 h)
研究者
研究点 (2)
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