ISSFAL publishes guidelines on analysis of omega-3 blood status in clinical research

By Stephen Daniells

- Last updated on GMT

© Getty Images / microgen
© Getty Images / microgen

Related tags omega-3 Clinical trials

The International Society for the Study of Fatty Acids and Lipids (ISSFAL) has released new guidelines to encourage best practice in clinical trial design and study interpretation.

The guidelines, which are published in Prostaglandins, Leukotrienes and Essential Fatty Acids, ​focus on the importance of measuring blood omega-3 long chain polyunsaturated fatty acid (PUFA) levels in research.

“It has been recognized for some time that many factors influence Omega-3 status of individuals,” ​states ISSFAL in a release. “At the same time studies involving supplementation with fish oils/Omega-3 fatty acids have shown differing, sometimes conflicting, results which may, at least in part be due to variations in subjects fatty acid status.”

The statement summarizes the various factors that influence omega-3 levels including gender, genetics, and age (non-modifiable factors) and form/bioavailability of supplements and a range of lifestyle factors (modifiable factors).

The ISSFAL statement concludes with the recommendations that:
-  in all research studies/trials subjects Omega-3 status is actually measured,
-  the influence of this on outcome measures is investigated,
-  published papers report full fatty acid profiles not just Omega-3 data.

The guidelines were authored by Renate de Groot from the Open University of the Netherlands and Barbara Meyer from University of Wollongong and Illawarra Health & Medical Research Institute (Australia).

Professor Meyer commented: “Specifically for clinical trials, researchers should consider the influence of fatty acid status (baseline, endpoint and change from baseline to endpoint) on the outcome variables, so we can attribute the change in the outcome variable to the change in Omega-3 levels.”

GOED: “Without data on omega-3 LCPUFA levels, it's not possible to determine the efficacy of supplementation”

The publication was welcomed by Harry Rice, PhD, VP of regulatory & scientific affairs for the Global Organization for EPA and DHA Omega-3s (GOED).

“GOED applauds ISSFAL's position on the need to assess blood omega-3 LCPUFA levels at baseline and post-intervention,”​ Dr Rice told us in an email. “Among the reasons to collect this data is for subject recruitment and confirmation of compliance. With respect to subject recruitment, over the years, we've seen that subjects with higher baseline omega-3 LCPUFA status may benefit less from supplemental EPA+DHA. Quite simply, without data on omega-3 LCPUFA levels, it's not possible to determine the efficacy of supplementation.

“As far as I'm concerned, assessing blood omega-3 LCPUFA status is as important as subject randomization. Just like you wouldn't conduct a clinical trial without randomizing subjects to the different groups, you shouldn't conduct an omega-3 clinical trial without measuring omega-3 LCPUFA status. “

Source: Prostaglandins, Leukotrienes and Essential Fatty Acids
Published online ahead of print, doi: 10.1016/j.plefa.2019.102029​   
“ISSFAL Official Statement Number 6: The importance of measuring blood omega-3 long chain polyunsaturated fatty acid levels in research”
Authors: Groot, B.J.Meyer

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