Conducting omega-3 clinical trials with cardiovascular outcomes: Proceedings of a workshop held at ISSFAL 2014

Abstract In contrast to earlier long-chain (LC) omega-3 (i.e. EPA and DHA) investigations, some recent studies have not demonstrated significant effects of EPA and DHA on cardiovascular disease (CVD) outcomes. The neutral findings may have been due to experimental design issues, such as: maintenance...

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Published in:Prostaglandins, leukotrienes and essential fatty acids leukotrienes and essential fatty acids, 2016-04, Vol.107, p.30-42
Main Authors: Rice, Harry B, Bernasconi, Aldo, Maki, Kevin C, Harris, William S, von Schacky, Clemens, Calder, Philip C
Format: Article
Language:English
Subjects:
Advanced Basic Science
Cardiovascular Agents - pharmacokinetics
Cardiovascular Agents - therapeutic use
Cardiovascular disease
Cardiovascular Diseases - drug therapy
Data Interpretation, Statistical
Design
Dietary Supplements
Docosahexaenic
Eicosapentaenoic
Endocrinology & Metabolism
Fatty Acids, Omega-3 - pharmacokinetics
Fatty Acids, Omega-3 - therapeutic use
Humans
Omega-3
Randomized Controlled Trials as Topic
Sample Size
Treatment Outcome
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Summary:Abstract In contrast to earlier long-chain (LC) omega-3 (i.e. EPA and DHA) investigations, some recent studies have not demonstrated significant effects of EPA and DHA on cardiovascular disease (CVD) outcomes. The neutral findings may have been due to experimental design issues, such as: maintenance on aggressive cardiovascular drug treatment overshadowing the benefits of LC omega-3s, high background LC omega-3 intake, too few subjects in the study, treatment duration too short, insufficient LC omega-3 dosage, increase in omega-6 fatty acid intake during the study, failure to assess the LC omega-3 status of the subjects prior to and during treatment and lack of clarity concerning which mechanisms were expected to produce benefits. At the 11th ISSFAL Congress, a workshop was held on conducting LC omega-3 clinical trials with cardiovascular outcomes, with the goal of gaining a better understanding concerning aspects of experimental design that should be considered when planning clinical studies related to EPA and DHA and potential cardiovascular benefits.
ISSN:0952-3278
1532-2823
DOI:10.1016/j.plefa.2016.01.003