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.

Omega-3 Index and Obstructive Sleep Apnea: A Cross-Sectional Study

“…There, erythrocyte fatty acid composition was analyzed according to the HS-Omega-3 Index methodology as previously described. 15 Fatty acid methyl esters were generated from erythrocytes by acid transesterification and analyzed by gas chromatography using a GC2010 Gas Chromatograph (Shimadzu, Duisburg, Germany) equipped with a SP2560, 100-m column (Supelco, Bellefonte, Pennsylvania, United States) using hydrogen as carrier gas. Fatty acids were identified by comparison with a standard mixture of fatty acids characteristic of erythrocytes.…”

“…At a target range between 8% and 11%, life expectancy is maximal, and risks for the comorbidities mentioned in the next paragraphs are minimal. 9,15 This trial design has been discussed in more detail for cardiovascular disease elsewhere. 9,15 As in all epidemiologic studies, causality is impossible to establish.…”

“…9,15 This trial design has been discussed in more detail for cardiovascular disease elsewhere. 9,15 As in all epidemiologic studies, causality is impossible to establish. Of note, the number of individuals with severe OSA was higher in our study (n = 128, Table 1) than in the study by Ladesich et al (n = 52), and the number of individuals with none/mild OSA was lower in our study (n = 113, Table 1) than in the study by Ladesich et al (n = 228).…”

Red blood cell oleic acid levels reflect olive oil intake while omega-3 levels reflect fish intake and the use of omega-3 acid ethyl esters: The Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico–Heart Failure trial

“…Its strengths include being the only study to date to determine the effects of 1 g of O3AEEs on the omega-3 index in the context of a large, prospective RCTs with fish oils. The collection of such data (both baseline and end of treatment) has recently been recommended by a workshop on how to improve the design of future RCTs with fish oil [48].…”

People with schizophrenia and depression have a low omega-3 index

“…The benefits of n-3 LCPUFA for cardiovascular health have been well established [12] (despite recent studies which are plagued by methodological issues, largely associated with the fact that they were conducted after 2000 and 2002 American Heart Foundation recommendations for increased fish and fish oil intake respectively, and subsequent exponential increase in fish oil imports [13,14]). Mechanisms for reducing CVD risk may include reduction of ventricular arrhythmia, thrombosis, triglycerides, atherosclerotic plaque, inflammation and hypertension, and endothelial relaxation [15].…”