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临床试验/ACTRN12620000836932
ACTRN12620000836932已完成未知

A study to evaluate the plasma absorption of 4 (four) EPA/DHA formulations on increasingOmega-3 fatty acid concentration in healthy participants over an 8-week period.

Pharmako Biotechnologies Pty Ltd0 个研究点目标入组 77 人开始时间: 2020年8月24日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
77

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
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Men and women aged over 18 years with normal dietary habits (no medically prescribed diet or slimming diet)
  • - No history or evidence of clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including
  • uncontrolled diabetes or thyroid disease) or haemotogical abnormalities that are uncontrolled.
  • - Participant’s full agreement and ability to consent to participation in the study
  • - Participant’s ability to participate fully and comply with demands of the study including
  • attendance at all scheduled blood collection time points.

排除标准

  • - Allergy to fish or shellfish
  • - Previous history of hematologic diseases (eg, known susceptibility to thrombosis)
  • - Concomitant use of anticoagulant drugs (eg Warfarin Sodium) and any other prescribed
  • medication except for females on the oral contraceptive pill
  • - Female participants currently pregnant or undergoing fertility treatment
  • - Regular use of supplements containing omega-3 fatty acids, regular consumption of foods
  • supplemented with omega-3 fatty acids such as some breads and milk products, consumption of fish as part of regular dietary patterns, high alcohol consumption (greater than 21 standard drinks/week)
  • - Reported participation in another omega-3 trial within 1 month before the start of the study
  • - Recent history (within 12 months) of substance abuse including alcohol
  • - Development of serious, adverse events/reactions including but not limited to; fainting, life threatening dehydration and/or serious bruising from blood sampling, excessive and prolonged
  • diarrhoea or gastrointestinal upset from fish oil consumption.
  • - Received treatment (radio &/or chemotherapy) for cancer (excluding SCC or BCC skin
  • cancer) in past 2 years.
  • - Current smoker.

研究者

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