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Best practices for design and implementation of human clinical trials studying dietary oils
Progress in Lipid Research ( IF 14.0 ) Pub Date : 2016-10-26 , DOI: 10.1016/j.plipres.2016.10.003
Dylan S. Mackay , Stephanie Jew , Peter J.H. Jones

Dietary oils are a significant contributor to overall energy and fatty acid intakes. Changes in the amount and/or type of dietary oils consumed have the potential to impact human health. Clinical trials represent the gold standard for testing the health impacts of such changes in dietary oils. The objective of this review is to explore best practices for clinical trials examining impacts of dietary oils including 1) pre-clinical topics such as research question generation, study design, participant population, outcome measures and intervention product selection and/or preparation; 2) clinical trial implementation topics such as recruitment, trial management, record keeping and compliance monitoring; and 3) post-clinical trial topics dealing with sample analysis and storage as well as management, publication and data access. The use of digital case report forms, and the best practices in reporting and publishing results are also addressed. In summary, properly designed and implemented clinical trials studying dietary oils produce strong scientific evidence-guiding their use.



中文翻译:

设计和实施有关食用油的人体临床试验的最佳实践

膳食油是总体能量和脂肪酸摄入量的重要贡献者。食用油的量和/或类型的变化可能会影响人体健康。临床试验代表测试这种食用油变化对健康的影响的金标准。这篇综述的目的是探索临床试验检查食用油影响的最佳实践,包括:1)临床前主题,例如研究问题的产生,研究设计,研究对象,结果指标以及干预产品的选择和/或准备;2)临床试验实施主题,例如招聘,试验管理,记录保存和合规性监控;3)临床后试验主题,涉及样品分析和存储以及管理,发布和数据访问。还讨论了数字病例报告表的使用以及报告和发布结果的最佳做法。总之,设计和实施适当的临床试验研究食用油可产生强有力的科学证据,指导其使用。

更新日期:2016-10-26
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