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Meta-Analysis
. 2018 Nov 27;11(11):CD012345.
doi: 10.1002/14651858.CD012345.pub3.

Polyunsaturated fatty acids for the primary and secondary prevention of cardiovascular disease

Asmaa S Abdelhamid  1 , Nicole Martin, Charlene Bridges, Julii S Brainard, Xia Wang, Tracey J Brown, Sarah Hanson, Oluseyi F Jimoh, Sarah M Ajabnoor, Katherine Ho Deane, Fujian Song, Lee Hooper
Affiliations
Meta-Analysis

Polyunsaturated fatty acids for the primary and secondary prevention of cardiovascular disease

Asmaa S Abdelhamid et al. Cochrane Database Syst Rev. .

Abstract

Background: Evidence on the health effects of total polyunsaturated fatty acids (PUFA) is equivocal. Fish oils are rich in omega-3 PUFA and plant oils in omega-6 PUFA. Evidence suggests that increasing PUFA-rich foods, supplements or supplemented foods can reduce serum cholesterol, but may increase body weight, so overall cardiovascular effects are unclear.

Objectives: To assess effects of increasing total PUFA intake on cardiovascular disease and all-cause mortality, lipids and adiposity in adults.

Search methods: We searched CENTRAL, MEDLINE and Embase to April 2017 and clinicaltrials.gov and the World Health Organization International Clinical Trials Registry Platform to September 2016, without language restrictions. We checked trials included in relevant systematic reviews.

Selection criteria: We included randomised controlled trials (RCTs) comparing higher with lower PUFA intakes in adults with or without cardiovascular disease that assessed effects over 12 months or longer. We included full texts, abstracts, trials registry entries and unpublished data. Outcomes were all-cause mortality, cardiovascular disease mortality and events, risk factors (blood lipids, adiposity, blood pressure), and adverse events. We excluded trials where we could not separate effects of PUFA intake from other dietary, lifestyle or medication interventions.

Data collection and analysis: Two review authors independently screened titles and abstracts, assessed trials for inclusion, extracted data, and assessed risk of bias. We wrote to authors of included trials for further data. Meta-analyses used random-effects analysis, sensitivity analyses included fixed-effects and limiting to low summary risk of bias. We assessed GRADE quality of evidence.

Main results: We included 49 RCTs randomising 24,272 participants, with duration of one to eight years. Eleven included trials were at low summary risk of bias, 33 recruited participants without cardiovascular disease. Baseline PUFA intake was unclear in most trials, but 3.9% to 8% of total energy intake where reported. Most trials gave supplemental capsules, but eight gave dietary advice, eight gave supplemental foods such as nuts or margarine, and three used a combination of methods to increase PUFA.Increasing PUFA intake probably has little or no effect on all-cause mortality (risk 7.8% vs 7.6%, risk ratio (RR) 0.98, 95% confidence interval (CI) 0.89 to 1.07, 19,290 participants in 24 trials), but probably slightly reduces risk of coronary heart disease events from 14.2% to 12.3% (RR 0.87, 95% CI 0.72 to 1.06, 15 trials, 10,076 participants) and cardiovascular disease events from 14.6% to 13.0% (RR 0.89, 95% CI 0.79 to 1.01, 17,799 participants in 21 trials), all moderate-quality evidence. Increasing PUFA may slightly reduce risk of coronary heart disease death (6.6% to 6.1%, RR 0.91, 95% CI 0.78 to 1.06, 9 trials, 8810 participants) andstroke (1.2% to 1.1%, RR 0.91, 95% CI 0.58 to 1.44, 11 trials, 14,742 participants, though confidence intervals include important harms), but has little or no effect on cardiovascular mortality (RR 1.02, 95% CI 0.82 to 1.26, 16 trials, 15,107 participants) all low-quality evidence. Effects of increasing PUFA on major adverse cardiac and cerebrovascular events and atrial fibrillation are unclear as evidence is of very low quality.Increasing PUFA intake probably slightly decreases triglycerides (by 15%, MD -0.12 mmol/L, 95% CI -0.20 to -0.04, 20 trials, 3905 participants), but has little or no effect on total cholesterol (mean difference (MD) -0.12 mmol/L, 95% CI -0.23 to -0.02, 26 trials, 8072 participants), high-density lipoprotein (HDL) (MD -0.01 mmol/L, 95% CI -0.02 to 0.01, 18 trials, 4674 participants) or low-density lipoprotein (LDL) (MD -0.01 mmol/L, 95% CI -0.09 to 0.06, 15 trials, 3362 participants). Increasing PUFA probably has little or no effect on adiposity (body weight MD 0.76 kg, 95% CI 0.34 to 1.19, 12 trials, 7100 participants).Effects of increasing PUFA on serious adverse events such as pulmonary embolism and bleeding are unclear as the evidence is of very low quality.

Authors' conclusions: This is the most extensive systematic review of RCTs conducted to date to assess effects of increasing PUFA on cardiovascular disease, mortality, lipids or adiposity. Increasing PUFA intake probably slightly reduces risk of coronary heart disease and cardiovascular disease events, may slightly reduce risk of coronary heart disease mortality and stroke (though not ruling out harms), but has little or no effect on all-cause or cardiovascular disease mortality. The mechanism may be via TG reduction.

PubMed Disclaimer

Conflict of interest statement

ASA: This review was funded by a grant from the World Health Organization. NM: None known CB: None known XW: This review was funded by a grant from the World Health Organization. JSB: This review was funded by a grant from the World Health Organization. TJB: This review was funded by a grant from the World Health Organization. SH: This review was funded by a grant from the World Health Organization. OFJ: This review was funded by a grant from the World Health Organization. SMAA: This review was funded by a grant from the World Health Organization. FS: This review was funded by a grant from the World Health Organization. KHOD: This review was funded by a grant from the World Health Organization. LH: This review was funded by a grant from the World Health Organization.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included trial
4
4
Funnel plot of comparison 2. Higher PUFA vs lower PUFA ‐ dichotomous secondary outcomes, outcome: 2.25 CORONARY HEART DISEASE (CHD) MORTALITY
See this image and copyright information in PMC

Update of

Comment in

References

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Nye 1990 {published data only}
    1. Ilsey CDJ, Nye ER, Sutherland W, Ram J, Ablett MB. Randomised placebo controlled trial of MAXEPA and aspirin/persantin after successful coronary angioplasty. Australian & New Zealand Journal of Medicine 1987;17:559.
    1. Nye ER, Ablett MB, Robertson MC, Ilsley CD, Sutherland WH. Effect of eicosapentaenoic acid on restenosis rate, clinical course and blood lipids in patients after percutaneous transluminal coronary angioplasty. Australian and New Zealand Journal of Medicine 1990;20(4):549‐52. - PubMed
ORL 2013 {published data only (unpublished sought but not used)}
    1. NCT01350999. Long‐term efficacy and safety study of TAK‐085 in participants with hypertriglyceridemia. clinicaltrials.gov/ct2/show/NCT01350999 (first posted 10 May 2011).
    1. Tatsuno I, Saito Y, Kudou K, Ootake J. Long‐term safety and efficacy of TAK‐085 in Japanese subjects with hypertriglyceridemia undergoing lifestyle modification: the omega‐3 fatty acids randomized long‐term (ORL) study. Journal of Clinical Lipidology 2013;7(6):615‐25. [PUBMED: 24314359] - PubMed
PREDIMED 2013 {published data only (unpublished sought but not used)}
    1. PREDIMED study ‐ Mediteranian diet in the primary prevention of cardiovascular disease: research protocol, version 1. www.predimed.es/uploads/8/0/5/1/8051451/_1estr_protocol_olf.pdf (accessed prior to 11 April 2018).
    1. Alvarez‐Perez J, Sanchez‐Villegas A, Diaz‐Benitez EM, Ruano‐Rodriguez C, Corella D, Martinez‐Gonzalez MA, et al. Influence of a Mediterranean dietary pattern on body fat distribution: results of the PREDIMED‐Canarias intervention randomized trial. Journal of the American College of Nutrition 2016;35(6):1‐13. - PubMed
    1. Babio N, Toledo E, Estruch R, Ros E, Martinez‐Gonzalez MA, Castaner O, et al. Mediterranean diets and metabolic syndrome status in the PREDIMED randomized trial. CMAJ Canadian Medical Association Journal 2014;186(17):E649‐57. - PMC - PubMed
    1. Barcelo F, Perona JS, Prades J, Funari SS, Gomez‐Gracia E, Conde M, et al. Mediterranean‐style diet effect on the structural properties of the erythrocyte cell membrane of hypertensive patients: the Prevencion con Dieta Mediterranea Study. Hypertension 2009;54(5):1143‐50. - PubMed
    1. Bullo M, Amigo‐Correig P, Marquez‐Sandoval F, Babio N, Martinez‐Gonzalez MA, Estruch R, et al. Mediterranean diet and high dietary acid load associated with mixed nuts: effect on bone metabolism in elderly subjects. Journal of the American Geriatrics Society 2009;57(10):1789‐98. - PubMed
Proudman 2015 {published and unpublished data}
    1. ACTRN12613000579796. Fish oil in recent onset rheumatoid arthritis: High versus low dose fish oil on a background of dose‐responsive combination disease‐modifying anti‐rheumatic drugs [Fish oil in anti‐inflammatory doses in recent onset rheumatoid arthritis: a randomized, double‐blind controlled trial within algorithm‐based drug use with DMARD use as the primary outcome]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364265 (date registered 23 May 2013).
    1. Proudman S, Spargo L, Hall C, McWilliams L, Lee A, Maureen R, et al. Fish oil in rheumatoid arthritis: a randomised, double blind trial comparing high dose with low dose. Internal Medicine Journal 2012;42(Suppl 1):2‐3.
    1. Proudman SM, Cleland LG, Metcalf RG, Sullivan TR, Spargo LD, James MJ. Plasma n‐3 fatty acids and clinical outcomes in recent‐onset rheumatoid arthritis. British Journal of Nutrition 2015;114(6):885‐90. [PUBMED: 26283657] - PubMed
    1. Proudman SM, James MJ, Spargo LD, Metcalf RG, Sullivan TR, Rischmueller M, et al. Fish oil in recent onset rheumatoid arthritis: a randomised, double‐blind controlled trial within algorithm‐based drug use. Annals of the Rheumatic Diseases 2015;74(1):89‐95. [PUBMED: 24081439] - PubMed
Puri 2005 {published and unpublished data}
    1. ISRCTN79170611. A multicentre, multinational, double blind, randomised, parallel group, placebo‐controlled study of ethyl‐eicosapentaenoate (EPA) in patients with Huntington's disease (HD). doi.org/10.1186/ISRCTN79170611 (date assigned 3 February 2003).
    1. Puri BK, Leavitt BR, Hayden MR, Ross CA, Rosenblatt A, Greenamyre JT, et al. Ethyl‐EPA in Huntington disease: a double‐blind, randomized, placebo‐controlled trial. Neurology 2005;65(2):286‐92. - PubMed
Raitt 2005 {published data only (unpublished sought but not used)}
    1. NCT00004558. Antiarrhythmic effects of n‐3 fatty acids. clinicaltrials.gov/ct2/show/NCT00004558 (first posted 10 February 2000).
    1. Raitt MH, Connor WE, Morris C, Kron J, Halperin B, Chugh SS, et al. Fish oil supplementation and risk of ventricular tachycardia and ventricular fibrillation in patients with implantable defibrillators: a randomized controlled trial. JAMA 2005;293(23):2884‐91. - PubMed
Rose 1965 {published data only}
    1. Rose GA, Thomson WB, Williams RT. Corn oil in treatment of ischaemic heart diseases. British Medical Journal 1965;1(5449):1531‐3. [PUBMED: 14288105] - PMC - PubMed
Rossing 1996 {published and unpublished data}
    1. Myrup B, Rossing P, Jensen T, Parving HH, Holmer G, Gram J, et al. Lack of effect of fish oil supplementation on coagulation and transcapillary escape rate of albumin in insulin‐dependent diabetic patients with diabetic nephropathy. Scandinavian Journal of Clinical & Laboratory Investigation 2001;61(5):349‐56. - PubMed
    1. Rossing P, Hansen BV, Nielsen FS, Myrup B, Holmer G, Parving HH. Fish oil in diabetic nephropathy. Diabetes Care 1996;19(11):1214‐9. - PubMed
Simon 1997 {published and unpublished data}
    1. Djuric Z, Heilbrun LK, Reading BA, Boomer A, Valeriote FA, Martino S. Effects of a low fat diet on levels of oxidative damage to DNA in human peripheral nucleated blood cells. Journal of the National Cancer Institute 1991;83(11):766‐9. - PubMed
    1. Djuric Z, Martino S, Heilbrun LK, Hart RW. Dietary modulation of oxidative DNA damage. Advances In Experimental Medicine and Biology 1994;354:71‐83. - PubMed
    1. Kasim SE, Martino S, Kim P‐N, Khilnani S, Boomer A, Depper J, et al. Dietary and anthropometric determinants of plasma lipoproteins during a long‐term low‐fat diet in healthy women. American Journal of Clinical Nutrition 1993;57:146‐53. - PubMed
    1. Simon MS, Heilbrun LK, Boomer A, Kresge C, Depper J, Kim PN, et al. A randomised trial of a low‐fat dietary intervention in women at high risk for breast cancer. Nutrition and Cancer 1997;27(2):136‐42. - PubMed
Sydney Diet‐Heart 1978 {published and unpublished data}
    1. Blacket RB, Leelarthaepin B, McGilchrist C, Palmer AJ, Woodhill JM. The synergistic effect of weight loss and changes in dietary lipids on the serum cholesterol of obese men with hypercholesterolaemia: implications for prevention of coronary heart disease. Australian and New Zealand Journal of Medicine 1979;9:521‐9. - PubMed
    1. Ramsden CE, Zamora D, Leelarthaepin B, Majchrzak‐Hong SF, Faurot KR, Suchindran CM, et al. Use of dietary linoleic acid for secondary prevention of coronary heart disease and death: evaluation of recovered data from the Sydney Diet Heart Study and updated meta‐analysis. BMJ 2013;346:e8707 (Erratum in: BMJ 2013;346:f903). - PMC - PubMed
    1. Woodhill JM, Palmer AJ, Leelarthaepin B, McGilchrist C, Blacket RB. Low fat, low cholesterol diet in secondary prevention of coronary heart disease. Advances in Experimental Medicine and Biology 1978;109:317‐30. - PubMed
Veterans Admin 1969 {published data only}
    1. Dayton S, Hashimoto S, Dixon W, Pearce ML. Composition of lipids in human serum and adipose tissue during prolonged feeding of a diet high in unsaturated fat. Journal of Lipid Research 1966;7:103‐11. - PubMed
    1. Dayton S, Hashimoto S, Pearce ML. Adipose tissue linoleic acid as a criterion of adherence to a modified diet. Journal of Lipid Research 1967;8:508‐10. - PubMed
    1. Dayton S, Hashimoto S, Pearce ML. Influence of a diet high in unsaturated fat upon composition of arterial tissue and atheromata in man. Circulation 1965;32:911‐24. - PubMed
    1. Dayton S, Hashimoto S, Rosenblum D, Pearce M. Vitamin E status of humans during prolonged feeding of unsaturated fats. Journal of Laboratory and Clinical Medicine 1965;65(5):739‐47. - PubMed
    1. Dayton S, Pearce ML. Diet and atherosclerosis. Lancet 1970;1(644):473‐4. - PubMed
Vijayakumar 2014 {published and unpublished data}
    1. Nandakumar S, Vijayakumar M, Krishnan S. Coconut oil vs sunflower oil in atherosclerosis: challenges in dietary intervention. Indian Heart Journal 2014;66:S11.
    1. Vijayakumar M, Krishnaan S, Sundram KR, Vasudevan DM, Nandakumar S. What oil in patients with established coronary artery disease: outcomes of two year dietary intervention with coconut oil & sunflower oil. Indian Heart Journal 2014;66:S12.
    1. Vijayakumar M, Vasudevan DM, Sundaram KR, Krishnan S, Vaidyanathan K, Nandakumar S, et al. A randomized study of coconut oil versus sunflower oil on cardiovascular risk factors in patients with stable coronary heart disease. Indian Heart Journal 2016;68:498‐506. [DOI: 10.1016/j.ihj.2015.10.384] - DOI - PMC - PubMed
WAHA ‐ Ros 2016 {published and unpublished data}
    1. Bitok E, Jaceldo‐Siegl K, Rajaram S, Serra‐Mir M, Roth I, Feitas‐Simoes T, et al. Favourable nutrient intake and displacement with long‐term walnut supplementation among elderly: results of a randomised trial. British Journal of Nutrition 2017;118(3):201‐9. [DOI: 10.1017/S0007114517001957] - DOI - PubMed
    1. Bitok E, Rajaram S, Ros E, Kazzi N, Huey L, Jaceldo K, et al. Does a daily walnut supplement given for a year result in body weight gain?. FASEB Journal 2016;30(1):1157.
    1. Huey L, Bitok E, Kazzi N, Sirirat R, Haddad Tabrizi S, Ros E, et al. Dietary compliance of walnut or no walnut intake in a 1‐year randomized intervention trial among free‐living elderly in the Walnuts and Healthy Aging Study (WAHA). FASEB Journal 2016; Vol. 30:1157.10.
    1. NCT01634841. Walnuts and Healthy Aging (WAHA). clinicaltrials.gov/ct2/show/NCT01634841 (first posted 6 July 2012).
    1. Rajaram S, Valls‐Pedret C, Cofan M, Sabate J, Serra‐Mir M, Perez‐Heras AM, et al. The Walnuts and Healthy Aging Study (WAHA): protocol for a nutritional intervention trial with walnuts on brain aging. Frontiers in Aging Neuroscience 2016;8:333. [PUBMED: 28119602] - PMC - PubMed
WELCOME 2015 {published and unpublished data}
    1. Bhatia L, Scorletti E, Curzen N, Clough GF, Calder PC, Byrne CD. Improvement in non‐alcoholic fatty liver disease severity is associated with a reduction in carotid intima‐media thickness progression. Atherosclerosis 2016;246:13‐20. [PUBMED: 26748347] - PubMed
    1. Byrne CD, Targher G. Ectopic fat, insulin resistance, and nonalcoholic fatty liver disease: implications for cardiovascular disease. Arteriosclerosis, Thrombosis, and Vascular Biology 2014;34(6):1155‐61. [PUBMED: 24743428] - PubMed
    1. Byrne CD, Targher G. Time to replace assessment of liver histology with MR‐based imaging tests to assess efficacy of interventions for nonalcoholic fatty liver disease. Gastroenterology 2016; Vol. 150, issue 1:7‐10. [PUBMED: 26602219] - PubMed
    1. Clough GF, McCormick KG, Scorletti E, Bhatia L, Calder PC, Griffin MJ, et al. Higher body fat percentage is associated with enhanced temperature perception in NAFLD: results from the randomised Wessex Evaluation of fatty Liver and Cardiovascular markers in NAFLD with OMacor thErapy trial (WELCOME) trial. Diabetologia 2016;59(7):1422‐9. [PUBMED: 27106721] - PubMed
    1. McCormick KG, Scorletti E, Bhatia L, Calder PC, Griffin MJ, Clough GF, et al. Impact of high dose n‐3 polyunsaturated fatty acid treatment on measures of microvascular function and vibration perception in non‐alcoholic fatty liver disease: results from the randomised WELCOME trial. Diabetologia 2015;58(8):1916‐25. [PUBMED: 26021488] - PubMed
WINS 2006 {published and unpublished data}
    1. Chlebowski RT, Blackburn GL, Buzzard IM, Rose DP, Martino S, Khandekar JD, et al. Adherence to a dietary fat intake reduction program in postmenopausal women receiving therapy for early breast cancer. The Women's Intervention Nutrition Study. Journal of Clinical Oncology 1993;11(11):2072‐80. - PubMed
    1. Chlebowski RT, Blackburn GL, Thomson CA, Nixon DW, Shapiro A, Hoy MK, et al. Dietary fat reduction and breast cancer outcome: interim efficacy results from the women's intervention nutrition study. JNCI Journal of the National Cancer Institute 2006;98(24):1767‐76. - PubMed
    1. Chlebowski RT, Rose DP, Buzzard IM, Blackburn GL, York M, Insull W, et al. Dietary fat reduction in adjuvant breast cancer therapy: current rationale and feasibility issues. Adjuvant. The Cancer Journal 1990;6:357‐63.
    1. Hoy MK, Winters BL, Chlebowski RT, Papoutsakis C, Shapiro A, Lubin MP, et al. Implementing a low‐fat eating plan in the Women's Intervention Nutrition Study. Journal of the American Dietetic Association 2009;109(4):688‐96. - PMC - PubMed
    1. Rose DP, Chlebowski RT, Connolly JM, Jones LA, Wynder EL. Effects of tamoxifen adjuvant therapy and a low‐fat diet on serum binding proteins and estradiol bioavailability in postmenopausal breast cancer patients. Cancer Research 1992;52:5386‐90. - PubMed

References to studies excluded from this review

ADCS‐Quinn 2010 {published data only}
    1. Quinn JF, Raman R, Thomas RG, Yurko‐Mauro K, Nelson EB, Dyck C, et al. Docosahexaenoic acid supplementation and cognitive decline in Alzheimer disease: a randomized trial. JAMA 2010;304(17):1903‐11. - PMC - PubMed
AFFORD 2014 {published data only}
    1. Nigam A, Talajic M, Roy D, Nattel S, Lambert J, Nozza A, et al. Fish oil for the reduction of atrial fibrillation recurrence, inflammation, and oxidative stress. Journal of the American College of Cardiology 2014;64(14):1441‐8. - PubMed
    1. Nigam A, Talajic M, Roy D, Nattel S, Lambert J, Nozza A, et al. Multicentre trial of fish oil for the reduction of atrial fibrillation recurrence, inflammation and oxidative stress: the Atrial Fibrillation Fish Oil Research Study. Canadian Journal of Cardiology 2013;1:S383. - PubMed
AlphaOmega ‐ EPA+DHA {published and unpublished data}
    1. Brouwer IA, Geleijnse JM, Klaasen VM, Smit LA, Giltay EJ, Goede J, et al. Effect of alpha linolenic acid supplementation on serum prostate specific antigen (PSA): results from the alpha omega trial. PLoS One 2013;8(12):e81519. - PMC - PubMed
    1. Eussen SR, Geleijnse JM, Giltay EJ, Rompelberg CJ, Klungel OH, Kromhout D. Effects of n‐3 fatty acids on major cardiovascular events in statin users and non‐users with a history of myocardial infarction. European Heart Journal 2012;33(13):1582‐8. - PMC - PubMed
    1. Geleijnse J, Giltay E, Kromhout D. Effects of n‐3 fatty acids on cognitive decline: a randomized double‐blind, placebo‐controlled trial in stable myocardial infarction patients. Alzheimer's & Dementia 2011;1:S512. - PubMed
    1. Geleijnse JM, Giltay EJ, Kromhout D. Effects of n‐3 fatty acids on cognitive decline: a randomized, double‐blind, placebo‐controlled trial in stable myocardial infarction patients. Alzheimer's & Dementia 2012;8(4):278‐87. - PubMed
    1. Geleijnse JM, Giltay EJ, Schouten EG, Goede J, Oude Griep LM, Teitsma‐Jansen AM, et al. Effect of low doses of n‐3 fatty acids on cardiovascular diseases in 4,837 post‐myocardial infarction patients: design and baseline characteristics of the Alpha Omega Trial. American Heart Journal 2010;159(4):539‐46. [DOI: ] - PubMed
AREDS2 2014 {published and unpublished data}
    1. Bonds DE, Harrington M, Worrall BB, Bertoni AG, Eaton CB, Hsia J, et al. Effect of long‐chain omega‐3 fatty acids and lutein + zeaxanthin supplements on cardiovascular outcomes: results of the Age‐Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA Internal Medicine 2014;174(5):763‐71. - PubMed
    1. Chew EY, Clemons T, SanGiovanni JP, Danis R, Domalpally A, McBee W, et al. The Age‐Related Eye Disease Study 2 (AREDS2): study design and baseline characteristics (AREDS2 report number 1). Ophthalmology 2012;119(11):2282‐9. - PMC - PubMed
    1. Chew EY, Clemons TE. In reply: making sense of the evidence from the age‐related eye disease study 2 randomized clinical trial. JAMA Ophthalmology 2014;132(8):1031‐2. - PubMed
    1. Chew EY, Clemons TE, Agron E, Launer LJ, Grodstein F, Bernstein PS, et al. Effect of omega‐3 fatty acids, lutein/zeaxanthin, or other nutrient supplementation on cognitive function: the AREDS2 randomized clinical trial. JAMA 2015;314(8):791‐801. - PMC - PubMed
    1. Chew EY, Clemons TE, SanGiovanni JP, Danis RP, Ferris FL III, Elman MJ, et al. Secondary analyses of the effects of lutein/zeaxanthin on age‐related macular degeneration progression: AREDS2 report No. 3. JAMA Ophthalmology 2014;132(2):142‐9. - PMC - PubMed
ASCEND {unpublished data only}
    1. Bowman L, Aung T, Haynes R, Armitage J. ASCEND: design and baseline characteristics of a large randomised trial in diabetes. Diabetes 2012;61:A556‐7.
Azadbakht 2007 {published and unpublished data}
    1. Azadbakht L, Mirmiran P, Esmaillzadeh A, Azizi F. Better dietary adherence and weight maintenance achieved by a long‐term moderate fat diet. British Journal of Nutrition 2007;97:399‐404. - PubMed
Baldassarre 2006 {published data only}
    1. Baldassarre D, Amato M, Eligini S, Barbieri SS, Mussoni L, Frigerio B, et al. Effect of n‐3 fatty acids on carotid atherosclerosis and haemostasis in patients with combined hyperlipoproteinemia: a double‐blind pilot study in primary prevention. Annals of Medicine 2006;38(5):367‐75. [DOI: 10.1080/07853890600852880] - DOI - PubMed
Berson 2004 {published data only}
    1. Berson EL, Rosner B, Sandberg MA, Weigel‐DiFranco C, Moser A, Brockhurst RJ, et al. Clinical trial of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment. Archives of Ophthalmology 2004;122(9):1297‐305. - PubMed
    1. Berson EL, Rosner B, Sandberg MA, Weigel‐DiFranco C, Moser A, Brockhurst RJ, et al. Further evaluation of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment: subgroup analyses. Archives of Ophthalmology 2004;122(9):1306‐14. - PubMed
Caldwell 2011 {published data only}
    1. Argo CK, Patrie JT, Lackner C, Henry TD, Lange EE, Weltman AL, et al. Effects of n‐3 fish oil on metabolic and histological parameters in NASH: a double‐blind, randomized, placebo‐controlled trial. Journal of Hepatology 2015;62(1):190‐7. [PUBMED: 25195547] - PMC - PubMed
    1. Caldwell SH, Argo CK, Henry TD, Lackner C, Pramoonjago P, Weltman AL, et al. Dissociated histological and metabolic effects of omega‐e (3000 mg/d) versus placebo with both exercise and diet in a double‐blind randomized controlled trial of NASH. Journal of Hepatology 2011; Vol. 54:S8.
DART 2 ‐ Burr 2003 {published and unpublished data}
    1. Burr ML, Ashfield‐Watt PA, Dunstan FD, Fehily AM, Breay P, Ashton T, et al. Lack of benefit of dietary advice to men with angina: results of a controlled trial. European Journal of Clinical Nutrition 2003;57(2):193‐200. - PubMed
    1. Ness AR, Ashfield‐Watt PAL, Whiting JM, Smith GD, Hughes J, Burr ML. The long‐term effect of dietary advice on the diet of men with angina: the diet and angina randomized trial. Journal of Human Nutrition and Dietetics 2004;17:1‐3. - PubMed
    1. Ness AR, Gallacher JE, Bennett PD, Gunnell DJ, Rogers PJ, Kessler D, et al. Advice to eat fish and mood: a randomised controlled trial in men with angina. Nutritional Neuroscience 2003;6(1):63‐5. - PubMed
DART fish Burr 1989 {published and unpublished data}
    1. Burr ML, Fehily AM. Fatty fish and heart disease: a randomized controlled trial. World Review of Nutrition and Dietetics 1991;66:306‐12. - PubMed
    1. Burr ML, Fehily AM. Fish and the heart [letter]. Lancet 1989;ii:1451‐2.
    1. Burr ML, Fehily AM, Gilbert JF, Rogers S, Holliday RM, Sweetnam PM, et al. Effects of changes in fat, fish, and fibre intakes on death and myocardial reinfarction: diet and reinfarction trial (DART). Lancet 1989;2(8666):757‐61. - PubMed
    1. Burr ML, Fehily AM, Rogers S, Welsby E, King S, Sandham S. Diet and reinfarction trial (DART): design, recruitment, and compliance. European Heart Journal 1989;10(6):558‐67. - PubMed
    1. Burr ML, Holliday RM, Fehily AM, Whitehead PJ. Haematological prognostic indices after myocardial infarction: evidence from the diet and reinfarction trial (DART). European Heart Journal 1992;13(2):166‐70. - PubMed
Derosa 2016 {published and unpublished data}
    1. Derosa G, Cicero AF, D'Angelo A, Borghi C, Maffioli P. Effects of n‐3 PUFAs on fasting plasma glucose and insulin resistance in patients with impaired fasting glucose or impaired glucose tolerance. BioFactors (Oxford, England) 2016;42(3):316‐22. [PUBMED: 27040503] - PubMed
Deslypere 1992 {published and unpublished data}
    1. Blok WL, Deslypere JP, Demacker PN, Ven‐Jongekrijg J, Hectors MP, Meer JW, et al. Pro‐ and anti‐inflammatory cytokines in healthy volunteers fed various doses of fish oil for 1 year. European Journal of Clinical Investigation 1997;27(12):1003‐8. [PUBMED: 9466128] - PubMed
    1. Deslypere JP. Influence of supplementation with n‐3 fatty acids on different coronary risk factors in men: a placebo controlled study. Verhandelingen ‐ Koninklijke Vlaamse Academie voor Geneeskunde van Belgie 1992;54(3):189‐216. [PUBMED: 1413984] - PubMed
    1. Katan MB, Deslypere JP, Birgelen AP, Penders M, Zegwaard M. Kinetics of the incorporation of dietary fatty acids into serum cholesteryl esters, erythrocyte membranes, and adipose tissue: an 18‐month controlled study. Journal of Lipid Research 1997;38(10):2012‐22. [PUBMED: 9374124] - PubMed
DISAF ‐ Harrison 2005 {published and unpublished data}
    1. Harrison RA, Elton P. From pies to pilchards: dietary assistants increase consumption of oil rich fish. Journal of Epidemiology and Community Health 2000;Suppl:6.
    1. Harrison RA, Elton PJ. Can an oil‐rich fish diet improve treatment outcomes following cardioversion for atrial fibrillation? A randomised controlled trial. Study design and compliance [poster]. International Society for the Study of Fatty Acids and Lipids (ISSFAL); 2003; Montreal, Canada. 2003.
    1. Harrison RA, Elton PJ. Is there a role for long‐chain omega3 or oil‐rich fish in the treatment of atrial fibrillation?. Medical Hypotheses 2005;64(1):59‐63. [PUBMED: 15533612] - PubMed
    1. Harrison RA, Purnell P, Elton PJ. Using community‐based dietary assistants to increase the intake of oil‐rich fish among older people. European Journal of Public Health 2003;13(Suppl 1):105.
DO Health {published data only}
    1. NCT01745263. DO‐HEALTH / vitamin D3 ‐ omega3 ‐ home exercise ‐ healthy ageing and longevity trial. clinicaltrials.gov/ct2/show/NCT01745263 (first posted 10 December 2012).
DO IT 2006 {published and unpublished data}
    1. Berstad P, Seljeflot I, Veierod MB, Hjerkinn EM, Arnesen H, Pedersen JI, et al. Supplementation with fish oil affects the association between very long‐chain n‐3 polyunsaturated fatty acids in serum non‐esterified fatty acids and soluble vascular cell adhesion molecule‐1. Clinical Science 2003;105(1):13‐20. - PubMed
    1. Ellingsen I, Hjerkinn EM, Seljeflot I, Arnesen H, Tonstad S, Ellingsen I, et al. Consumption of fruit and berries is inversely associated with carotid atherosclerosis in elderly men. British Journal of Nutrition 2008;99(3):674‐81 (Erratum in: British Journal of Nutrition 2008;99(3):697). - PubMed
    1. Ellingsen I, Seljeflot I, Arnesen H, Tonstad S, et al. Vitamin C consumption is associated with less progression in carotid intima media thickness in elderly men: a 3‐year intervention study. Nutrition Metabolism & Cardiovascular Diseases 2009;19(1):8‐14. - PubMed
    1. Furenes EB, Seljeflot I, Solheim S, Hjerkinn EM, Arnesen H, Furenes EB, et al. Long‐term influence of diet and/or omega‐3 fatty acids on matrix metalloproteinase‐9 and pregnancy‐associated plasma protein A in men at high risk of coronary heart disease. Scandinavian Journal of Clinical & Laboratory Investigation 2008;68(3):177‐84. - PubMed
    1. Hjerkinn EM, Abdelnoor M, Breivik L, Bergengen L, Ellingsen I, Seljeflot I, et al. Effect of diet or very long chain omega‐3 fatty acids on progression of atherosclerosis, evaluated by carotid plaques, intima‐media thickness and by pulse wave propagation in elderly men with hypercholesterolaemia. European Journal of Cardiovascular Prevention & Rehabilitation 2006;13(3):325‐33. - PubMed
DO IT ‐ Einvik 2010 {published and unpublished data}
    1. Berstad P, Seljeflot I, Veierod MB, Hjerkinn EM, Arnesen H, Pedersen JI. Supplementation with fish oil affects the association between very long‐chain n‐3 polyunsaturated fatty acids in serum non‐esterified fatty acids and soluble vascular cell adhesion molecule‐1. Clinical Science 2003;105(1):13‐20. - PubMed
    1. Eid HM, Arnesen H, Hjerkinn EM, Lyberg T, Ellingsen I, Seljeflot I. Effect of diet and omega‐3 fatty acid intervention on asymmetric dimethylarginine. Nutrition & Metabolism 2006;3:4. - PMC - PubMed
    1. Eid HMA, Arnesen H, Hjerkinn EM, Lyberg T, Ellingsen I, Seljeflot I. Effect of diet and omega‐3 fatty acid intervention on asymmetric dimethylarginine. Nutrition and Metabolism 2006;3:1‐10. - PMC - PubMed
    1. Einvik G, Ekeberg O, Lavik JG, Ellingsen I, Klemsdal TO, Hjerkinn EM. The influence of long‐term awareness of hyperlipidemia and of 3 years of dietary counseling on depression, anxiety, and quality of life. Journal of Psychosomatic Research 2010;68(6):567‐72. - PubMed
    1. Einvik G, Klemsdal TO, Sandvik L, Hjerkinn EM. A randomized clinical trial on n‐3 polyunsaturated fatty acids supplementation and all‐cause mortality in elderly men at high cardiovascular risk. European Journal of Cardiovascular Prevention & Rehabilitation 2010;17(5):588‐92. - PubMed
EPE‐A study 2014 {published and unpublished data}
    1. Sanyal AJ, Abdelmalek MF, Suzuki A, Cummings OW, Chojkier M. No significant effects of ethyl‐eicosapentanoic acid on histologic features of nonalcoholic steatohepatitis in a phase 2 trial. Gastroenterology 2014;147(2):377‐84.e1. [PUBMED: 24818764] - PubMed
Erdogan 2007 {published data only}
    1. Erdogan A, Bayer M, Kollath D, Greiss H, Voss R, Neumann T, et al. Omega AF study: polyunsaturated fatty acids (PUFA) for prevention of atrial fibrillation relapse after successful external cardioversion. Heart Rhythm 2007;4(5):S185‐6.
    1. Heidt MC, Vician M, Stracke SKH, Stadlbauer T, Grebe MT, Boening A, et al. Beneficial effects of intravenously administered n‐3 fatty acids for the prevention of atrial fibrillation after coronary artery bypass surgery: a prospective randomized study. Thoracic and Cardiovascular Surgeon 2009;57:276‐80. [DOI: 10.1055/s-0029-1185301] - DOI - PubMed
    1. Mariani J, Doval HC, Nul D, Varini S, Grancelli H, Ferrante D, et al. N‐3 polyunsaturated fatty acids to prevent atrial fibrillation: updated systematic review and meta‐analysis of randomized controlled trials. Journal of the American Heart Association 2013;2(1):e005033. - PMC - PubMed
Finnish Mental Hosp 1972 {published data only}
    1. Miettinen M, Turpeinen O, Karvonen MJ, Elosuo R, Paavilainen E. Effect of cholesterol‐lowering diet on mortality from coronary heart‐disease and other causes: a twelve‐year clinical trial in men and women. Lancet 1972;2(782):835‐8. - PubMed
    1. Miettinen M, Turpeinen O, Karvonen MJ, Pekkarinen M, Paavilainen E, Elosuo R. Dietary prevention of coronary heart disease in women: the Finnish mental hospital study. International Journal of Epidemiology 1983;12(1):17‐25. - PubMed
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FLAX‐PAD 2013 {published data only}
    1. Caligiuri SP, Aukema HM, Ravandi A, Guzman R, Dibrov E, Pierce GN. Flaxseed consumption reduces blood pressure in patients with hypertension by altering circulating oxylipins via an alpha‐linolenic acid‐induced inhibition of soluble epoxide hydrolase. Hypertension 2014;64(1):53‐9. [PUBMED: 24777981] - PubMed
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    1. Edel AL, Rodriguez‐Leyva D, Maddaford TG, Caligiuri SP, Austria JA, Weighell W, et al. Dietary flaxseed independently lowers circulating cholesterol and lowers it beyond the effects of cholesterol‐lowering medications alone in patients with peripheral artery disease. Journal of Nutrition 2015;145(4):749‐57. [PUBMED: 25694068] - PubMed
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FORWARD 2013 {published and unpublished data}
    1. Macchia A, Grancelli H, Varini S, Nul D, Laffaye N, Mariani J, et al. Omega‐3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: results of the FORWARD (randomized trial to assess efficacy of PUFA for the maintenance of sinus rhythm in persistent atrial fibrillation) trial. Journal of the American College of Cardiology 2013;61(4):463‐8. [PUBMED: 23265344] - PubMed
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FOSTAR 2016 {published and unpublished data}
    1. Chen JS, Hill CL, Lester S, Ruediger CD, Battersby R, Jones G, et al. Supplementation with omega‐3 fish oil has no effect on bone mineral density in adults with knee osteoarthritis: a 2‐year randomized controlled trial. Osteoporosis International 2016;27(5):1897‐905. [PUBMED: 26694596] - PubMed
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Franzen 1993 {published and unpublished data}
    1. Franzen D. Unknown. Catheterization and Cardiovascular Diagnosis 1993;28:301‐10. - PubMed
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Gill 2012 {published data only}
    1. Gill EA, Chen MA, Paramsothy P, Fish B, Isquith D, Thirumalai A, et al. Abstract 12697: Omega‐3 fatty acids effects on carotid IMT in metabolic syndrome. Circulation 2014;130:A1269.
    1. Gill EA, Chen MA, Thirumalai A, Fish B, Paramsothy P. Omega‐3 fatty acids improve dyslipidemia but not inflammatory markers in metabolic syndrome. Journal of Clinical Lipidology 2012;6:278‐9.
GISSI‐HF 2008 {published data only}
    1. Aleksova A, Masson S, Maggioni AP, Lucci D, Fabbri G, Beretta L, et al. N‐3 polyunsaturated fatty acids and atrial fibrillation in patients with chronic heart failure: the GISSI‐HF trial. European Journal of Heart Failure 2013;15(11):1289‐95. - PubMed
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    1. Cowie MR, Cure S, Bianic F, McGuire A, Goodall G, Tavazzi L. Cost‐effectiveness of highly purified omega‐3 polyunsaturated fatty acid ethyl esters in the treatment of chronic heart failure: results of Markov modelling in a UK setting. European Journal of Heart Failure 2011;13(6):681‐9. [DOI: 10.1093/eurjhf/hfr023] - DOI - PubMed
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    1. Finzi AA, Latini R, Barlera S, Rossi MG, Ruggeri A, Mezzani A, et al. Effects of n‐3 polyunsaturated fatty acids on malignant ventricular arrhythmias in patients with chronic heart failure and implantable cardioverter‐defibrillators: a substudy of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza Cardiaca (GISSI‐HF) trial. American Heart Journal 2011;161(2):338‐43. [DOI: 10.1016/j.ahj.2010.10.032] - DOI - PubMed
GISSI‐P 1999 {published data only}
    1. Franzosi MG, Brunetti M, Marchioli R, Marfisi RM, Tognoni G, Valagussa F, et al. Cost‐effectiveness analysis of n‐3 polyunsaturated fatty acids (PUFA) after myocardial infarction: results from Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto (GISSI)‐Prevenzione trial. Pharmacoeconomics 2001;19(4):411‐20. - PubMed
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JELIS 2007 {published and unpublished data}
    1. Cleland JG, Freemantle N, Coletta AP, Clark AL. Clinical trials update from the American Heart Association: REPAIR‐AMI, ASTAMI, JELIS, MEGA, REVIVE‐II, SURVIVE, and PROACTIVE. The European Journal of Heart Failure 2006;8(1):105‐10. [DOI: 10.1016/j.ejheart.2005.12.003] - DOI - PubMed
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Lorenz‐Meyer 1996 {published and unpublished data}
    1. Lorenz‐Meyer H, Bauer P, Nicolay C, Schulz B, Purrmann J, Fleig WE, et al. Omega‐3 fatty acids and low carbohydrate diet for maintenance of remission in Crohn's disease. A randomized controlled multicenter trial. Study Group Members (German Crohn's Disease Study Group). Scandinavian Journal of Gastroenterology 1996;31(8):778‐85. - PubMed
Mansel 1990 {published data only}
    1. Mansel RE, Gateley CA, Harrison BJ, Melhuish J, Sheridan W, Pye JK, et al. Effects and tolerability of n‐6 essential fatty acid supplementation in patients with recurrent breast cysts: a randomized double‐blind placebo‐controlled trial. Journal of Nutritional Medicine 1990;1(3):195.
    1. Mansel RE, Harrison BJ, Melhuish J, Sheridan W, Pye JK, Pritchard G, et al. A randomized trial of dietary intervention with essential fatty acids in patients with categorized cysts. Annals of the New York Academy of Sciences 1990;586:288‐94. - PubMed
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MAPT 2017 {published data only}
    1. Andrieu S, Guyonnet S, Coley N, Cantet C, Bonnefoy M, Bordes S, et al. Effect of long‐term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo‐controlled trial. Lancet Neurology 2017;16:377‐89. [DOI: 10.1016/S1474-4422(17)30040-6] - DOI - PubMed
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MARGARIN Bemelmans 2002 {published data only (unpublished sought but not used)}
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MENU ‐ Rock 2016 {published data only}
    1. Le T, Flatt SW, Natarajan L, Pakiz B, Quintana EL, Heath DD, et al. Effects of diet composition and insulin resistance status on plasma lipid levels in a weight loss intervention in women. Journal of the American Heart Association 2016;5(1):e002771. [DOI: 10.1161/JAHA.115.002771] - DOI - PMC - PubMed
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Michalsen 2006 {published data only}
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Middleton 2002 {published data only}
    1. Middleton SJ, Naylor S, Woolner J, Hunter JO. A double‐blind, randomized, placebo‐controlled trial of essential fatty acid supplementation in the maintenance of remission of ulcerative colitis. Alimentary Pharmacology & Therapeutics 2002;16(6):1131‐5. [PUBMED: 12030955] - PubMed
Minnesota Coronary 1989 {published data only}
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Moy 2001 {published and unpublished data}
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NAT2 2015 {published data only}
    1. Merle BM, Benlian P, Puche N, Bassols A, Delcourt C, Souied EH. Circulating omega‐3 fatty acids and neovascular age‐related macular degeneration. Investigative Ophthalmology & Visual Science 2014;55(3):2010‐9. [PUBMED: 24557349] - PubMed
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Norouzi 2014 {published data only}
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Norwegian ‐ Natvig 1968 {published data only}
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NutriStroke 2009 {published data only}
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OFAMI ‐ Nilsen 2001 {published and unpublished data}
    1. Aarsetoy H, Brugger‐Andersen T, Hetland O, Grundt H, Nilsen DW. Long term influence of regular intake of high dose n‐3 fatty acids on CD40‐ligand, pregnancy‐associated plasma protein A and matrix metalloproteinase‐9 following acute myocardial infarction. Thrombosis & Haemostasis 2006;95(2):329‐36. - PubMed
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OMEGA 2014 {published and unpublished data}
    1. Rauch B, Riemer T, Schwaab B, Schneider S, Diller F, Gohlke H, et al. Short‐term comprehensive cardiac rehabilitation after AMI is associated with reduced 1‐year mortality: results from the OMEGA study. European Journal of Preventive Cardiology 2014;21(9):1060‐9. - PubMed
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OPAL ‐ Dangour 2010 {published and unpublished data}
    1. Dangour AD, Allen E, Elbourne D, Fasey N, Fletcher AE, Hardy P, et al. Effect of 2‐y n‐3 long‐chain polyunsaturated fatty acid supplementation on cognitive function in older people: a randomized, double‐blind, controlled trial. American Journal of Clinical Nutrition 2010;91(6):1725‐32. - PubMed
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ORIGIN 2012 {published data only}
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Oslo Diet‐Heart 1966 {published and unpublished data}
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Oxford Retinopathy 1978 {published and unpublished data}
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Özaydin 2011 {published data only}
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POUNDS Lost Sacks 2009 {published and unpublished data}
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Ramirez‐Ramirez 2013 {published data only}
    1. Ramirez‐Ramirez V, Macias‐Islas MA, Ortiz GG, Pacheco‐Moises F, Torres‐Sanchez ED, Sorto‐Gomez TE, et al. Efficacy of fish oil on serum of TNF α , IL‐1 β , and IL‐6 oxidative stress markers in multiple sclerosis treated with interferon beta‐1b. Oxidative Medicine and Cellular Longevity 2013;2013:709493. [DOI: 10.1155/2013/709493] - DOI - PMC - PubMed
    1. Sorto‐Gomez TE, Ortiz GG, Pacheco‐Moises FP, Torres‐Sanchez ED, Ramirez‐Ramirez V, Macias‐Islas MA, et al. Effect of fish oil on glutathione redox system in multiple sclerosis. American Journal of Neurodegenerative Disease 2016;5(2):145‐51. - PMC - PubMed
Reed 2014 {published and unpublished data}
    1. Olendzki BC, Leung K, Buskirk S, Reed G, Zurier RB. Treatment of rheumatoid arthritis with marine and botanical oils: influence on serum lipids. Evidence‐Based Complementary & Alternative Medicine: eCAM 2011;2011:827286. - PMC - PubMed
    1. Reed GW, Leung K, Rossetti RG, Vanbuskirk S, Sharp JT, Zurier RB. Treatment of rheumatoid arthritis with marine and botanical oils: an 18‐month, randomized, and double‐blind trial. Evidence‐Based Complementary & Alternative Medicine: eCAM 2014;2014:857456. - PMC - PubMed
Risk and Prevention {published and unpublished data}
    1. Rischio and Prevenzione Investigators. Efficacy of n‐3 polyunsaturated fatty acids and feasibility of optimizing preventive strategies in patients at high cardiovascular risk: rationale, design and baseline characteristics of the Rischio and Prevenzione study, a large randomised trial in general practice. Trials 2010;11(1):68. [DOI: 10.1186/1745-6215-11-68] - DOI - PMC - PubMed
    1. Roncaglioni MC, Tombesi M, Avanzini F, Barlera S, Caimi V, Longoni P, et al. N‐3 fatty acids in patients with multiple cardiovascular risk factors. New England Journal of Medicine 2013;368(19):1800‐8. - PubMed
    1. Visentin G, Risk & Prevention Study Group. Towards evidence‐based practice via practice‐based evidence: the Italian experience. Family Practice 2008;25 Suppl 1:i71‐4. - PubMed
Sandhu 2016 {published data only}
    1. Sandhu N, Schetter SE, Liao J, Hartman TJ, Richie JP, McGinley J, et al. Influence of obesity on breast density reduction by omega‐3 fatty acids: evidence from a randomized clinical trial. Cancer Prevention Research (Philadelphia, Pa.) 2016;9(4):275‐82. [PUBMED: 26714774] - PubMed
    1. Signori C, DuBrock C, Richie JP, Prokopczyk B, Demers LM, Hamilton C, et al. Administration of omega‐3 fatty acids and Raloxifene to women at high risk of breast cancer: interim feasibility and biomarkers analysis from a clinical trial. European Journal of Clinical Nutrition 2012;66(8):878‐84. [PUBMED: 22669332] - PubMed
Schirmer 2007 {published data only}
    1. Schirmer MA, Phinney SD. Gamma‐linolenate reduces weight regain in formerly obese humans. Journal of Nutrition 2007;137(6):1430‐5. [PUBMED: 17513402] - PubMed
SCIMO ‐ von Schacky 1999 {published and unpublished data}
    1. Angerer P, Kothny W, Stork S, Schacky C. Effect of dietary supplementation with omega‐3 fatty acids on progression of atherosclerosis in carotid arteries. Cardiovascular Research 2002;54(1):183‐90. - PubMed
    1. Schacky C, Angerer P, Kothny W, Theisen K, Mudra H. The effect of dietary omega‐3 fatty acids on coronary atherosclerosis. A randomized, double‐blind, placebo‐controlled trial. Annals of Internal Medicine 1999;130(7):554‐62. - PubMed
    1. Schacky C, Baumann K, Angerer P. The effect of n‐3 fatty acids on coronary atherosclerosis: results from SCIMO, an angiographic study, background and implications. Lipids 2001;36 Suppl:S99‐102. - PubMed
Shinto 2014 {published data only}
    1. NCT00090402. Fish oil and alpha lipoic acid in treating Alzheimer's Disease. clinicaltrials.gov/ct2/show/NCT00090402 (first posted 26 August 2014).
    1. Shinto L, Quinn J, Montine T, Dodge HH, Woodward W, Baldauf‐Wagner S, et al. A randomized placebo‐controlled pilot trial of omega‐3 fatty acids and alpha lipoic acid in Alzheimer's disease. Journal of Alzheimer's Disease 2014;38(1):111‐20. [PUBMED: 24077434] - PMC - PubMed
SHOT ‐ Eritsland 1996 {published and unpublished data}
    1. Eritsland J, Arnesen H, Berg K, Seljeflot I, Abdelnoor M. Serum Lp(a) lipoprotein levels in patients with coronary artery disease and the influence of long‐term n‐3 fatty acid supplementation. Scandinavian Journal of Clinical and Laboratory Investigation 1995;55(4):295‐300. - PubMed
    1. Eritsland J, Arnesen H, Gronseth K, Fjeld NB, Abdelnoor M. Effect of dietary supplementation with n‐3 fatty acids on coronary artery bypass graft patency. American Journal of Cardiology 1996;77(1):31‐6. - PubMed
    1. Eritsland J, Arnesen H, Gronseth K, Fjeld NB, Abdelnoor M. Effect of supplementation with n‐3 fatty acids on graft patency in patients undergoing coronary artery bypass operation. Results from SHOT study. European Heart Journal 1994;15:29.
    1. Eritsland J, Arnesen H, Seljeflot I, Hostmark AT. Long‐term metabolic effects of n‐3 polyunsaturated fatty acids in patients with coronary artery disease. American Journal of Clinical Nutrition 1995;61(4):831‐6. - PubMed
    1. Eritsland J, Arnesen H, Seljeflot I, Kierulf P. Long‐term effects of n‐3 polyunsaturated fatty acids on haemostatic variables and bleeding episodes in patients with coronary artery disease. Blood Coagulation & Fibrinolysis 1995;6(1):17‐22. - PubMed
Sianni 2013 {published data only}
    1. Sianni A, Matsoukis I, Ganotopoulou A, Paraskevas P, Asimis A, Tsivilis N, et al. PP128‐sun effect of omega 3 fatty acids in patients with hypertension and atrial fibrillation. Clinical Nutrition 2013;32(Suppl 1):S70‐1.
SMART Tapsell 2013 {published data only}
    1. Anil S, Charlton KE, Tapsell LC, Probst Y, Ndanuko R, Batterham MJ. Identification of dietary patterns associated with blood pressure in a sample of overweight Australians. Journal of Human Hypertension 2016;30(11):672‐8. [DOI: 10.1038/jhh.2016.10] - DOI - PubMed
    1. Tapsell LC, Batterham MJ, Charlton KE. Effect of dietary restriction and n‐3 PUFA supplementation on insulin resistance in obese adults. FASEB Journal 2010;24:733.9.
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SOFA 2006 {published and unpublished data}
    1. Brouwer IA, Katan MB, Schouten EG, Camm AJ, Hauer RNW, Wever EFD, et al. Rationale and design of a clinical trial on n‐3 fatty acids and cardiac arrhythmia (SOFA). Annals of Nutrition & Metabolism 2001;45(Suppl 1):79.
    1. Brouwer IA, Raitt MH, Dullemeijer C, Kraemer DF, Zock PL, Morris C, et al. Effect of fish oil on ventricular tachyarrhythmia in three studies in patients with implantable cardioverter defibrillators. European Heart Journal 2009;30(7):820‐6. - PMC - PubMed
    1. Brouwer IA, Zock PL, Camm AJ, Böcker D, Hauer RN, Wever EF, et al. Effect of fish oil on ventricular tachyarrhythmia and death in patients with implantable cardioverter defibrillators: the Study on Omega‐3 Fatty Acids and Ventricular Arrhythmia (SOFA) randomized trial. JAMA 2006;295(22):2613‐9. - PubMed
    1. Brouwer IA, Zock PL, Wever EFD, Hauer RNW, Camm AJ, Bocker D, et al. Rationale and design of a randomised controlled clinical trial on supplemental intake of n‐3 fatty acids and incidence of cardiac arrhythmia: SOFA. European Journal of Clinical Nutrition 2003;57:1323‐30. - PubMed
Sofi 2010 {published data only}
    1. Sofi F, Giangrandi I, Cesari F, Corsani I, Abbate R, Gensini GF, et al. Effects of a 1‐year dietary intervention with n‐3 polyunsaturated fatty acid‐enriched olive oil on non‐alcoholic fatty liver disease patients: a preliminary study. International Journal of food Sciences and Nutrition 2010;61(8):792‐802. [PUBMED: 20465434] - PubMed
STARS 1992 {published and unpublished data}
    1. Blann AD, Jackson P, Bath PM, Watts GF. Von Willebrand factor, a possible indicator of endothelial cell damage, decreases during long‐term compliance with a lipid‐lowering diet. Journal of Internal Medicine 1995;237:557‐61. - PubMed
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    1. Watts GF, Jackson P, Burke V, Lewis B. Dietary fatty acids and progression of coronary artery disease in men. American Journal of Clinical Nutrition 1996;64:202‐9. - PubMed
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Stoll 2001 {published data only}
    1. NCT00010868. Omega‐3 fatty acids in bipolar disorder. clinicaltrials.gov/ct2/show/NCT00010868 (first posted 5 February 2001).
STRENGTH {published data only}
    1. NCT02104817. Outcomes study to assess statin residual risk reduction with EpaNova in high CV risk patients with hypertriglyceridemia (STRENGTH). clinicaltrials.gov/ct2/show/NCT02104817 2014.
SU.FOL.OM3 Galan 2010 {published and unpublished data}
    1. Ahluwalia N, Blacher J, Szabo De Edelenyi F, Faure P, Julia C, Hercberg S, et al. Prognostic value of multiple emerging biomarkers in cardiovascular risk prediction in patients with stable cardiovascular disease. Atherosclerosis 2013;228(2):478‐84. - PubMed
    1. Andreeva VA, Galan P, Torres M, Julia C, Hercberg S, Kesse‐Guyot E. Supplementation with B vitamins or n‐3 fatty acids and depressive symptoms in cardiovascular disease survivors: ancillary findings from the SUpplementation with FOLate, vitamins B‐6 and B‐12 and/or OMega‐3 fatty acids (SU.FOL.OM3) randomized trial. American Journal of Clinical Nutrition 2012;96(1):208‐14. - PubMed
    1. Andreeva VA, Kesse‐Guyot E, Barberger‐Gateau P, Fezeu L, Hercberg S, Galan P. Cognitive function after supplementation with B vitamins and long‐chain omega‐3 fatty acids: ancillary findings from the SU.FOL.OM3 randomized trial. American Journal of Clinical Nutrition 2011;94(1):278‐86. - PubMed
    1. Andreeva VA, Latarche C, Hercberg S, Briancon S, Galan P, Kesse‐Guyot E. B vitamin and/or n‐3 fatty acid supplementation and health‐related quality of life: ancillary findings from the SU.FOL.OM3 randomized trial. PLoS One 2014;9(1):e84844. - PMC - PubMed
    1. Andreeva VA, Touvier M, Kesse‐Guyot E, Julia C, Galan P, Hercberg S. B vitamin and/or omega‐3 fatty acid supplementation and cancer: ancillary findings from the supplementation with folate, vitamins B6 and B12, and/or omega‐3 fatty acids (SU.FOL.OM3) randomized trial. Archives of Internal Medicine 2012;172(7):540‐7. - PubMed
Søndergaard 2003 {published and unpublished data}
    1. Sondergaard E, Moller JE, Egstrup K. Effect of dietary intervention and lipid‐lowering treatment on brachial vasoreactivity in patients with ischemic heart disease and hypercholesterolemia. American Heart Journal 2003;145(5):E19. - PubMed
Tande 2016 {published data only}
    1. Tande KS, Vo TD, Lynch BS. Clinical safety evaluation of marine oil derived from Calanus finmarchicus. Regulatory Toxicology and Pharmacology : RTP 2016;80:25‐31. [PUBMED: 27233921] - PubMed
Tay 2015 {published data only}
    1. Tay J, Luscombe‐Marsh ND, Thompson CH, Noakes M, Buckley JD, Wittert GA, et al. Comparison of low‐ and high‐carbohydrate diets for type 2 diabetes management: a randomized trial. American Journal of Clinical Nutrition 2015;102(4):780‐90. - PubMed
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THIS DIET ‐ Tuttle 2008 {published and unpublished data}
    1. Tuttle KR, Shuler LA, Packard DP, Milton JE, Daratha KB, Bibus DM, et al. Comparison of low‐fat versus Mediterranean‐style dietary intervention after first myocardial infarction (from The Heart Institute of Spokane Diet Intervention and Evaluation Trial). American Journal of Cardiology 2008;101(11):1523‐30. [PUBMED: 18489927] - PubMed
VITAL {published data only}
    1. Bassuk SS, Manson JE, Lee IM, Cook NR, Christen WG, Bubes VY, et al. Baseline characteristics of participants in the VITamin D and OmegA‐3 TriaL (VITAL). Contemporary Clinical Trials 2016;47:235‐43. - PMC - PubMed
    1. Gold DR, Litonjua AA, Carey VJ, Manson JE, Buring JE, Lee IM, et al. Lung VITAL: rationale, design, and baseline characteristics of an ancillary study evaluating the effects of vitamin D and/or marine omega‐3 fatty acid supplements on acute exacerbations of chronic respiratory disease, asthma control, pneumonia and lung function in adults. Contemporary Clinical Trials 2016;47:185‐95. - PMC - PubMed
    1. Gold DR, Luttmann‐Gibson H, Litonjua AA, Friedenberg G, Gordon D, Lee IM, et al. Baseline chronic obstructive pulmonary disease in the lung vitamin D and omega‐3 trial. American Journal of Respiratory and Critical Care Medicine 2014;189:D44 COPD.
    1. Kang JH, Grodstein F, Manson JAE. Cognitive substudy of the vitamin d and omega‐3 trial (VITAL‐Cog): design of a large randomized trial of omega‐3 and vitamin d supplements in relation to cognitive change. Alzheimer's & Dementia 2015;1:608.
    1. LeBoff MS, Yue AY, Copeland T, Cook NR, Buring JE, Manson JE. VITAL‐bone health: rationale and design of two ancillary studies evaluating the effects of vitamin D and/or omega‐3 fatty acid supplements on incident fractures and bone health outcomes in the VITamin D and OmegA‐3 TriaL (VITAL). Contemporary Clinical Trials 2015;41:259‐68. - PMC - PubMed
Weinstock‐Guttman 2005 {published data only}
    1. Weinstock‐Guttman B, Baier M, Park Y, Feichter J, Lee‐Kwen P, Gallagher E, et al. Low fat dietary intervention with n‐3 fatty acid supplementation in multiple sclerosis patients. Prostaglandins, Leukotrienes and Essential Fatty Acids 2005;73:397‐404. [DOI: 10.1016/j.plefa.2005.05.024] - DOI - PubMed
WHI 2006 {published data only}
    1. Anderson G, Cummings S, Freedman LS, Furberg C, Henderson M, Johnson SR, et al. Design of the Women's Health Initiative clinical trial and observational study. Controlled Clinical Trials 1998;19(1):61‐109. - PubMed
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    1. Beresford SA, Johnson KC, Ritenbaugh C, Lasser NL, Snetselaar LG, Black HR, et al. Low‐fat dietary pattern and risk of colorectal cancer: the Women's Health Initiative Randomized Controlled Dietary Modification Trial. JAMA 2006;295(6):643‐54. - PubMed
    1. Bowen D, Ehret C, Pedersen M, Snetselaar L, Johnson M, Tinker L, et al. Results of an adjunct dietary intervention program in the Women's Health Initiative. Journal of the American Dietetic Association 2002;102(11):1631‐7. - PubMed
    1. Carty CL, Kooperberg C, Neuhouser ML, Tinker L, Howard B, Wactawski‐Wende J, et al. Low‐fat dietary pattern and change in body‐composition traits in the Women's Health Initiative Dietary Modification Trial. American Journal of Clinical Nutrition 2011;93:516‐24. - PMC - PubMed
Zhang 2016 {published data only}
    1. Zhang YP, Miao R, Li Q, Wu T, Ma F. Effects of DHA supplementation on hippocampal volume and cognitive function in older adults with mild cognitive impairment: A 12‐month randomized, double‐blind, placebo‐controlled trial. Journal of Alzheimer's Disease 2016;55(2):497‐507. - PubMed

References to ongoing studies

AC Omega3 {published data only}
    1. ACTRN12614000732684. The Aboriginal cardiovascular omega‐3 randomised controlled trial [The effect of omega‐3 supplementation on adverse cardiovascular (CV) events among Indigenous Australians with stable coronary artery disease: a randomized controlled trial]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366337 (date registered 10 July 2014).
ACTRN12610000594022 {published data only}
    1. ACTRN12610000594022. Fish oil as adjunct therapy for periodontitis [Clinical efficacy of fish oil as adjunct therapy for patients with chronic periodontitis]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=335470 (date registered 23 July 2010).
ACTRN12613000034730 {published data only}
    1. ACTRN12613000034730. Intervention of testosterone & fish oil as a possible strategy for the prevention of Alzheimer’s Disease [A 56 week, double‐blind, randomised, placebo‐controlled trial to determine the efficacy of testosterone, with and without DHA supplementation in PiB positive men with subjective memory complaints as a strategy to prevent the development of Alzheimer’s disease]. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363372 (date registered 14 January 2013).
AFORRD {published and unpublished data}
    1. Holman RR, Paul S, Farmer A, Tucker L, Stratton IM, Neil HA, et al. Atorvastatin in factorial with omega‐3 EE90 risk reduction in diabetes (AFORRD): a randomised controlled trial. Diabetologia 2009;52(1):50‐9. - PubMed
    1. Neil HA, Ceglarek U, Thiery J, Paul S, Farmer A, Holman RR. Impact of atorvastatin and omega‐3 ethyl esters 90 on plasma plant sterol concentrations and cholesterol synthesis in type 2 diabetes: a randomised placebo controlled factorial trial. Atherosclerosis 2010;213(2):512‐7. - PubMed
Beyond Aging Project {published data only}
    1. Cockayne NL, Duffy SL, Bonomally R, English A, Amminger PG, Mackinnon A, et al. The Beyond Ageing Project Phase 2‐‐a double‐blind, selective prevention, randomised, placebo‐controlled trial of omega‐3 fatty acids and sertraline in an older age cohort at risk for depression: study protocol for a randomized controlled trial. Trials 2015;16:247. - PMC - PubMed
Chandrakala 2010 {published data only (unpublished sought but not used)}
    1. Chandrakala G, Arpana G, Rao PV. Long‐term effects of a reduced fat diet intervention in pre‐diabetes. professional.diabetes.org/meeting/scientific‐sessions/70th‐scientific‐se... (accessed before 11 April 2018).
    1. Chandrakala G, Arpana G, Sreenivas T, Rao PV. Low‐fat (<20%) diets prevent type 2 diabetes mellitus. Diabetes 2012;61:A190.
n‐3 for Vascular Cognitive Aging {published data only}
    1. Shinto L, Silbert LC, Dodge HH, Quinn JF, Howieson D, Kaye J, et al. Omega 3 fatty acids for the prevention of vascular cognitive aging: methods and rationale for a phase II trial. Alzheimer's & Dementia 2015:P2‐305.
n‐3 on plasma lipid {published data only}
    1. ChiCTR‐TRC‐12002014. Influence of different source of n‐3 fatty acid on plasma lipid in moderately hypercholesterolemia subject and the valid dosage. www.chictr.org.cn/hvshowproject.aspx?id=2374 (date last refreshed on 3 May 2015).
NCT00309439 {published data only}
    1. NCT00309439. ALA and prostate cancer. clinicaltrials.gov/ct2/show/NCT00309439 (first posted 31 March 2006).
NCT00410020 {published data only}
    1. NCT00410020. Arrhythmia prevention with an alpha‐linolenic enriched diet. clinicaltrials.gov/ct2/show/NCT00410020 (first posted 12 December 2006).
NCT01047449 {published data only}
    1. NCT01047449. Improving the results of heart bypass surgery using new approaches to surgery and medication (SUPERIORSVG). clinicaltrials.gov/ct2/show/NCT01047449 (first posted 13 January 2010).
NCT01513252 {published data only}
    1. NCT01513252. Long‐term effects of interventional strategies to prevent cognitive decline in elderly (MAPT‐PLUS). clinicaltrials.gov/ct2/show/NCT01513252 (first posted 20 January 2012).
NCT01784042 {published data only}
    1. NCT01784042. Dietary energy restriction and omega‐3 fatty acids on mammary tissue. clinicaltrials.gov/ct2/show/NCT01784042 (first posted 5 February 2013).
NCT02128763 {published data only}
    1. NCT02128763. Dry eye assessment and management study (DREAM). clinicaltrials.gov/ct2/show/NCT02128763 (first posted 1 May 2014).
NCT02211560 {published data only}
    1. NCT02211560. Investigating a phosphatidylserine based dietary approach for the management of mild cognitive impairment. clinicaltrials.gov/ct2/show/NCT02211560 (first posted 7 August 2014).
NCT02295059 {published data only}
    1. NCT02295059. Omega 3 fatty acids and ERPR(‐)HER2(+/‐) breast cancer prevention. clinicaltrials.gov/ct2/show/NCT02295059 (first posted 20 November 2014).
NCT02676466 {published data only}
    1. NCT02676466. The ENRGISE pilot study (ENRGISE). clinicaltrials.gov/ct2/show/NCT02676466 (first posted 8 February 2016).
NCT02719327 {published data only}
    1. NCT02719327. Brain amyloid and vascular effects of eicosapentaenoic acid (BRAVE‐EPA). clinicaltrials.gov/ct2/show/NCT02719327 (first posted 25 March 2016).
OMEMI {published data only}
    1. Laake K, Myhre P, Nordby LM, Seljeflot I, Abdelnoor M, Smith P, et al. Effects of omega 3 supplementation in elderly patients with acute myocardial infarction: design of a prospective randomized placebo controlled study. BMC Geriatrics 2014;14:74. [http://www.biomedcentral.com/1471‐2318/14/74] - PMC - PubMed
    1. Laake K, Seljeflot I, Schmidt EB, Myhre P, Tveit A, Arnesen H, et al. Serum fatty acids, traditional risk factors, and comorbidity as related to myocardial injury in an elderly population with acute myocardial infarction. Journal of Lipids 2016;2016:4945720. [http://dx.doi.org/10.1155/2016/4945720] - PMC - PubMed
REDUCE‐IT {published data only}
    1. Bhatt DL, Steg G, Brinton EA, Jacobson TA, Miller M, Tardif J‐C, et al. Rationale and design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clinical Cardiology 2017;40:138‐48. [DOI: 10.1002/clc.22692] - DOI - PMC - PubMed
seAFOOD {published data only}
    1. Hull MA, Sandell AC, Montgomery AA, Logan RF, Clifford GM, Rees CJ, et al. A randomized controlled trial of eicosapentaenoic acid and/or aspirin for colorectal adenoma prevention during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme (The seAFOod Polyp Prevention Trial): study protocol for a randomized controlled trial. Trials 2013;14:237. - PMC - PubMed
    1. ISRCTN05926847. The seAFOod (Systematic Evaluation of Aspirin and Fish Oil) polyp prevention trial. www.isrctn.com/ISRCTN05926847 (data assigned 6 May 2011).
UMIN000012825 {published data only}
    1. UMIN000012825. Effect of polysaturated fatty acids on vascular healing process in hyper‐cholesterolemic patients with acute coronary syndrome. upload.umin.ac.jp/cgi‐open‐bin/ctr_e/ctr_view.cgi?recptno=R000014981 (first posted 1 February 2014).

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References to other published versions of this review

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