“The outcome doesnot question the current authoritative dietary recommendations and advices for omega 3 intakes on which our products are based,” Unilever’s Flip Dotsch told NutraIngredients.com this morning.
The ALPHA-OMEGA trial saw almost 5000, 60-80 year old male and female heart attack survivors consuming varying levels of EPA (eicosapentaenoic acid), DHA (docosahexaenoic acid) and ALA (alpha-linolenic acid) via non-commercial Unilever omega-3 spreads developed for the study for 40 months.
One group consumed 376mg of marine sourced DHA and EPA; another had 1.9g of soy and walnut sourced ALA; a third group had a spread fortified with all three fatty acids and a fourth was placebo.
After the 40 months, 13.9 per cent of the participants, who were 75 per cent male and 24 per cent obese, had suffered another cardiac event among all the groups.
Unsurprisingly, Unilever said it found the results surprising, especially when the body of EPA/DHA scientific literature was considered.
“The study outcome for EPA and DHA is surprising considering the weight of evidence published to date,” Unilever said in a statement. “This could be the result of methodological issues such as the relatively low daily dosage compared to previous studies or the fact that in this study serious cardiovascular events were much lower than in studies performed in the past. This is probably due to extensive drug treatment that is nowadays applied.”
It said its “science experts” were looking at the paper in greater detail.
The European Food Safety Authority has issued a positive opinion on ALA, saying it supports lowering of blood cholesterol, but EPA/DHA were not backed for the same effect in an opinion published in October 2009.
Lead researcher, Daan Kromhout, PhD, of Wageningen University in the Netherlands, said that while the study found omega-3 fatty acid-enriched margarines "had no effect on the rate of major cardiovascular events”, improvements in medical treatment could have been a factor.
The EPA-DHA daily dose of 400mg was half that recommended by the American Heart Association.
Kromhout noted "the patients in this trial were very well treated" with many taking blood pressure and cholesterol drugs, a factor that made, “beneficial effect of low doses of EPA-DHA difficult to prove."
The findings were presented at the European Society of Cardiology Congress and simultaneously published in the New England Journal of Medicine.
Unilever added: “We welcome this well-executed study as a valuable addition to the growing body of evidence on the role of omega 3s in cardiovascular health. Unilever is proud to have supported this important study and has a long history of supporting scientific investigation into cardiovascular disease and its management through diet and lifestyle.”
Source: New England Journal of Medicine
‘n–3 Fatty Acids and Cardiovascular Events after Myocardial Infarction’
Authors: Daan Kromhout, M.P.H., PhD, Erik J. Giltay, M.D., PhD, Johanna M. Geleijnse, PhD