GOED just returned from the 11th Biennial Congress of the International Society for the Study of Fatty Acids and Lipids (ISSFAL) held in Stockholm, Sweden. As you might imagine, there was no shortage of presentations and discussions on research related to EPA and DHA. It was an honor to be involved in the meeting. Not only did I present a poster on GOED’s commissioned blood pressure meta-analysis, which was used as the basis for our FDA health claim petition, but I had the honor of chairing the GOED-sponsored workshop on designing omega-3 clinical trials with cardiovascular outcomes. That workshop took place on Monday, June 30 with an attendance of approximately 150 people. The feedback received thus far has been overwhelmingly positive. The workshop may be over, but the intent is to quickly publish the proceedings for everyone to read and reference for years to come.
The idea for the workshop was born from frustration over the last several years with the publication of a seemingly excessive number of neutral cardiovascular studies with perhaps less than optimal experimental designs. While any and all of the studies could have been neutral because there is no benefit of EPA/DHA, given past findings, that's highly unlikely.
During the workshop, the following omega-3 experts shared their insights on why past clinical trials have failed to detect benefits and how future investigations can be designed to increase the likelihood of success:
Aldo Bernasconi, PhD
Director of Information and Research, GOED
Presentation Title: Statistical Power
Kevin C. Maki, PhD
Chief Science Officer, Midwest Center for Metabolic and Cardiovascular Research
Presentation Title: Design Issues for Clinical Trials of Omega-3 Products Assessing Cardiovascular Outcomes
William S. Harris, PhD
Senior Scientist, Health Diagnostic Laboratory, Inc.
Research Professor, University of South Dakota
Presentation Title: Measuring Omega-3 Fatty Acid Status
Clemens von Schacky, MD
Preventive Cardiology Unit Lead at the Ludwig Maximilians-University of Munich
Founder and Owner, Omegametrix
Presentation Title: Omega-3 Status and Study Design
Philip C. Calder, PhD
Professor of Nutritional Immunology, University of Southampton
Presentation Title: Patterns of omega-3 intake and omega-3 and -6 status
Here are some of the high level conclusions from the workshop.
- In order to detect an effect, you must have sufficient power (i.e. enough subjects).
- An adequate dosage should be used to produce the mechanistic change(s) through which a cardiovascular benefit might be anticipated.
- An appropriate study population should be enrolled to test the hypothesized effect. For example, it may be difficult to detect an effect in a population of polydrug users.
- Omega-3 status should be measured at baseline and during treatment. Make low omega-3 status an inclusion criterion.
- The omega-3 fatty acid content of most circulating sample types are reasonably well-correlated, so any, in theory, could be used as a biomarker. However, keep in mind that plasma levels respond more quickly than cellular levels to supplementation but are more variable within a person.
- Omega-3 supplements should be provided with the main meal in order to increase bioavailability.
- Incorporation of EPA and DHA is increased with more frequent intake, so consider the dosing regimen.
Stockholm is such a spectacular city that I feel compelled to share with you the venues where the different events took place. The three days of presentations were held at The Brewery®, which closed in 1971 after producing beer for over 100 years. The opening reception took place at the Stockholm City Hall, venue of the Nobel Prize banquet held on 10 December each year. The ISSFAL “gala” was held at the Vasa Museum. Where else but Stockholm can you eat dinner next to a 400 year old boat? Following the official close of the ISSFAL meeting, there was a full day of workshops at the Artipelag. I hope to see you at the 12th ISSFAL Congress in Cape Town, South Africa.