title: 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 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.
authors: Global Organization for EPA and DHA Omega-3s (GOED), Salt Lake City, UT, USA. Electronic address: harry@goedomega3.com.
authors: Harry B
authors: HB
authors: Rice
authors: Global Organization for EPA and DHA Omega-3s (GOED), Salt Lake City, UT, USA.
authors: Aldo
authors: A
authors: Bernasconi
authors: Midwest Center for Metabolic and Cardiovascular Research, Glen Ellyn, IL, USA.
authors: Kevin C
authors: KC
authors: Maki
authors: Health Diagnostic Laboratory, Inc., Richmond, VA, USA; University of South Dakota School of Medicine, Sioux Falls, SD, USA; OmegaQuant Analytics, LLC, Sioux Falls, SD, USA.
authors: William S
authors: WS
authors: Harris
authors: Ludwig Maximilians-University of Munich; Omegametrix, Munich, Germany.
authors: Clemens
authors: C
authors: von Schacky
authors: Faculty of Medicine, University of Southampton, Southampton, United Kingdom; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, United Kingdom.
authors: Philip C
authors: PC
authors: Calder
mesh_terms: D002317:Cardiovascular Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000188:drug therapy*; D003627:Data Interpretation, Statistical; D019587:Dietary Supplements; D015525:Fatty Acids, Omega-3 / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D018401:Sample Size; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D015525:Fatty Acids, Omega-3
keywords: Cardiovascular disease; Design; Docosahexaenic; Eicosapentaenoic; Omega-3