Omega 3 clinical trials

Omega-3 fatty acids have been linked to a wide-range of health benefits, including cardiovascular disease (CVD), good development of a baby during pregnancy, joint health, behaviour and mood, and certain cancers. The risk of pollutants from oily fish, such a methyl mercury, dioxins, and polychlorinated biphenols (PCBs) have led some to advise a reduced fresh fish intake, especially for pregnant women who may damage the development of their babies. Such advice has seen the number of omega-3 enriched or fortified products on the market increase. Most extracted fish oils are molecularly distilled and steam deodorised to remove contaminants. But fears about dwindling fish stocks have pushed some companies to start extracting omega-3 from algae. Indeed, Martek Biosciences and Lonza are amongst those already offering algae-derived omega-3 DHA as a dietary supplement. The European omega-3 market was worth around €160m (£108m) in 2004, says Frost and Sullivan, and is expected to grow at rates of 8 per cent on average to 2010. According to Mintel's Global New Products Database (GNPD) the launch of omega-3-containing product across Europe has increased from 153 in 2004 to 208 in 2005. 2006 has seen 72 launches so far. NutraIngredients-USA.com presents a concise list of ongoing clinical trials around the world, exploring new applications and opportunities for omega-3 fatty acids. A wide variety of diseases are being investigated around the world, and the effects of omega-3 fatty acids on improving the symptoms or preventing the onset of disease is being evaluated. Six studies are focussing on the potential benefits of omega-3s and heart conditions, some of which may help clarify the situation that was recently blurred after a meta-analysis in the British Medical Journal concluded that no benefits were afforded by the fish oils. A further seven studies are looking at the effects of omega-3s on cognitive and mental health, ranging from depression to schizophrenia. Trial Phase Trial Name Intervention Condition Date of completion Location III (2400 subjects) Supplementation with Folate (and vitamins B6 and B12) and/or Omega 3 Fatty Acids on the prevention of recurrent ischaemic events in patients who have already experienced a coronary or cerebrovascular event 5-methyl-THF (560 g), vitamin B6 (3 mg); B12 (20 g) and/or omega-3 supplements (600 mg with an EPA:DHA ratio of 2:1) versus placebo Cardio and neurovascular diseases June 30, 2009 France III (200 subjects) The Impact of Fish Oil Emulsion on Clinical Outcome of Post-Operative Cancer Patients Fish oil emulsion (Omegaven) Carcinoma Surgery Parenteral Nutrition June 2006 China 100 subjects The effect of combined n-3 polyunsaturated fatty acid and antioxidant dietary supplements on Crohn's disease & the associated osteoporosis, malnutrition and morbidity fish oil (1.62 g EPA, 1.08 g DHA) + antioxidant vitamins containing: selenium 200 ug manganese 3 mg vitamin A 450 ug vitamin E 30 ug vitamin C 90 mg Inflammatory bowel disease Osteoporosis Ongoing follow-up UK N/A (4000 subjects) Alpha Omega Trial: Study of Omega-3 Fatty Acids and Coronary Mortality omega-3 fatty acids Coronary Heart Disease July 2009 Netherlands I An adaptogenic role for omega-3 fatty acids in stress; a randomised placebo controlled double blind intervention study (pilot) 6 g Fish oil per day, containing 1.5 g DHA Perceived stress Not available Australia 300 subjects The Influence of n-3 Fatty acid Supplementation on Vascular and Cognitive Function in Healthy Young Adults; a Randomized Controlled Trial DHA Cardiovascular disease Not available UK 1000 subjects Atorvastatin in Factorial with Omega-3 fatty acid Risk Reduction in Diabetes statin or Omega-3 or statin + Omega-3 Type 2 Diabetes Late 2006 UK 800 subjects The OPAL Study: Older People And n-3 Long-chain polyunsaturated fatty acids 0.7 g of n-3 long chain polyunsaturated fatty acids Cognitive and retinal function March 31, 2007 UK 10000 subjects A Study of Cardiovascular Events iN Diabetes (ASCEND) 100 mg daily aspirin versus placebo and/or supplementation with 1 g daily omega-3 fatty acids or placebo Diabetes (Type 1 & 2) March 1, 2011 UK N/A Omega-3-polyunsaturated fatty acids and atherosclerosis in systemic lupus erythematosus (SLE) fish oil capsules or placebo Systemic lupus erythematosus (SLE) August 1, 2008 UK 40 subjects Effects of enteral nutrition enriched with omega-3 fatty acids on outcome in non-small cell lung cancer patients. Daily supplement with 2 g EPA Non Small Cell Lung Cancer September 1st , 2006 Netherlands 60 subjects PUFA Augmentation in Treatment of Major Depression EPA Major Depression July 2006 USA III (260 subjects) Treatment of Rheumatoid Arthritis With Marine and Botanical Oils Fish oil Rheumatoid Arthritis Not available USA 450 subjects Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite omega-3 fatty acids Anorexia Cachexia 2007 USA II (60 subjects) DHA and X-Linked Retinitis Pigmentosa DHA Retinitis Pigmentosa X-Linked Genetic Diseases August 2009 USA III Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies Omega-3 fish oils Preterm Birth December 2007 USA IV Omegaven (w-3 Fish Oil) Supplemented Parenteral Nutrition in Subjects of SICU Omegaven (omega-3 Fish Oil) Critical ill patients in SICU March 2007 Taiwan II (30 subjects) Effect of Omega-3 PUFA Supplementation in NAFLD Patients Omega-3 fish oils Non-Alcoholic Fatty Liver Disease December 2006 USA IV (30 subjects) Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors EPA-rich supplement Colorectal Neoplasms Hepatocellular Carcinoma Cholangiocarcinoma December 2007 Germany 140 subjects A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants Supplement of fatty acid (DHA and AA) Very Low Birthweight Infants December 2007 Norway I/II (60 subjects) Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis Fish oils Multiple Sclerosis Depression June 2009 USA 170 subjects Omega-3 Fatty Acids to Improve Depression and Reduce Cardiovascular Risk Factors Omega-3 fatty acids Cardiovascular Diseases Depression Heart Diseases Myocardial Infarction Angina, Unstable Not available USA IV The Benefit of Adding Fish Oil to the Nutrition of Critically Ill Patients omega-3 fatty acids Sepsis Syndrome Not available Germany II/II Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure PUFA (EPH/DHA 1:1.2) Chronic Heart Failure Not available Austria II (60 subjects) CAD Risk in Schizophrenia: Effect of Omega-3 Fatty Acid Supplementation EPA Schizophrenia Coronary Artery Disease Not available USA II (30 subjects) Influence of DHA-Rich Supplement on DHA-Status and Health Evolution of Patients With Cystic Fibrosis DHA-rich supplement Cystic Fibrosis Not available UK II (128 subjects) A Study of Omega-3 as a Treatment for Major Depression Omega-3 fatty acids Major Depression Dysthymia Not available Australia 40 subjects Omega-3 Fatty Acids in Adolescent Depression Omega-3 fatty acids Adolescent Depression Not available USA