DRKS00029183已完成未知
Bioavailability of three different Omega-3 fatty acid products in healthy subjects – a randomized, three-way cross-over study - BTS1507/20
Evonik Operations GmbH | Nurition & Care0 个研究点目标入组 21 人开始时间: 2022年7月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Men and women with low consumption of fatty fish, defined as a frequency of less than twice per month
- •No fish consumption at least two weeks prior to screening visit
- •No current omega-3 or cod liver oil supplementation, nor use of flaxseeds or other plant sources of linoleic acid
- •Omega-3 index in erythrocytes: = 6.0%
- •BMI from 18.5 to 29.9 kg/m²
- •WHR of = 0.90 in men and = 0.85 in women
- •Non-smoker
排除标准
- •(1) Diagnosis of a clinically significant endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, gastrointestinal, or biliary disorder that may interfere with the interpretation of the study results
- •(2) Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants (e.g. Marcumar), diuretics, thiazides), which in the investigator’s opinion would impact subject safety
- •(3) Significant changes in lifestyle or medication (within last 2 months)
- •(4) A recent history (prior 5 years) or presence of cancer
- •(5) Difficulty swallowing capsules or predicted inability to swallow the study products
- •(6) Individuals who have made a blood donation in excess of 500 mL or who had excess blood loss within the 3 months before the study starts
- •(7) Individuals who are currently enrolled in an ongoing clinical trial or who have been an active participant in a clinical trial within the last 3 months (i.e. no clinical study activity for 3 months)
- •(8) Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study
- •(9) A known allergy or hypersensitivity to any of the ingredients of the study products
- •(10) Not willing to abstain from fish consumption or foods/oils high in omega-3 fatty acids
- •(11) For this study clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
- •(12) If female: currently pregnant, planning to become pregnant during the study period, breastfeeding (a pregnancy test will be conducted during screening and visits 1-3)
- •(13) Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
研究者
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