Alpha Omega Trial: Study of Omega-3 Fatty Acids and Coronary Mortality
Alpha Omega Trial: A Randomised, Placebo Controlled, Double Blind Intervention Study of the Effect of Low Doses of Omega-3 Fatty Acids on Cardiovascular Diseases in Patients With a History of Myocardial Infarction
4 other identifiers
interventional
4,837
1 country
32
Brief Summary
The Alpha Omega Trial is a randomized, placebo-controlled, double-blind dietary intervention study in 4837 postmyocardial infarction patients in the Netherlands to examine whether incidence of cardiovascular diseases during 40 months of follow-up can be prevented by low doses of omega-3 polyunsaturated fatty acids. The key objectives are:
- to examine the effect of low-dose supplementation (400 mg/day) of eicosapentaenoic acid and docosahexaenoic acid on incidence of cardiovascular diseases; and
- to examine the effect of low-dose supplementation (2 g/day) of alpha-linolenic acid on incidence of cardiovascular diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Apr 2002
Longer than P75 for not_applicable cardiovascular-diseases
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 3, 2005
CompletedFirst Posted
Study publicly available on registry
August 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJuly 7, 2010
July 1, 2010
7.6 years
August 3, 2005
July 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG)
monitored during intervention
Secondary Outcomes (6)
Incident CVD, which comprises fatal CVD, non-fatal myocardial infarction, non-fatal cardiac arrest and non-fatal stroke
monitored during intervention
Fatal CVD, which comprises mortality from ischaemic heart disease, fatal cardiac arrest, sudden death undefined, mortality from heart failure and fatal stroke
monitored during intervention
Fatal CHD, which comprises mortality from ischaemic heart disease, mortality from cardiac arrest, and sudden death undefined
monitored during intervention
All-causes mortality
monitored during intervention
The composite of sudden death undefined and nonfatal and fatal cardiac arrest
monitored during intervention
- +1 more secondary outcomes
Study Arms (4)
EPA + DHA
EXPERIMENTALMargarine spread that yields 400 mg of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) per day for average margarine use of 20 grams per day
ALA
EXPERIMENTALMargarine spread that yields 2 grams of alpha-linolenic acid (ALA) per day for average margarine use of 20 grams per day
EPA + DHA plus ALA
EXPERIMENTALMargarine spread that yields 400 mg of EPA + DHA per day plus 2 grams of ALA per day, for average margarine use of 20 grams per day
Placebo
PLACEBO COMPARATORMargarine spread that contains no EPA, DHA or ALA (exchanged for oleic acid)
Interventions
Daily use of margarine spread (approximately 20 grams) during 40 months
Eligibility Criteria
You may qualify if:
- Men and women
- Aged 60 through 80 y
- Verified clinically diagnosed myocardial infarction up to 10 y before randomization
- Written informed consent
You may not qualify if:
- Living in a nursing home or other institution
- Participation in another scientific study
- Habitual margarine intake \< 10 g per day
- Habitual fish intake \> 150 g per day
- Habitual alcohol intake \> 6 drinks per day
- Use of fish oil capsules or other supplements containing omega-3 fatty acids
- Presence of cancer with \< 1 y of life expectancy
- Cognitive impairment, as indicated by the Mini Mental State Examination (score \<= 21)
- Unintended weight loss \> 5 kg in the past year
- Lack of facilities for cooled margarine storage at home
- Inability or unwillingness to comply with study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wageningen Universitylead
- Netherlands Heart Foundationcollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Unilever R&Dcollaborator
Study Sites (32)
Medisch Centrum Alkmaar
Alkmaar, 1815 JD, Netherlands
Flevo Ziekenhuis
Almere Stad, 1315 RA, Netherlands
Meander Medisch Centrum
Amersfoort, 3800 BM, Netherlands
Sint Lucas Andreas Ziekenhuis
Amsterdam, 1006 AE, Netherlands
BovenIJ Ziekenhuis
Amsterdam, 1034 CS, Netherlands
Slotervaartziekenhuis
Amsterdam, 1066 EC, Netherlands
Gelre ziekenhuizen
Apeldoorn, Netherlands
Lievensberg Ziekenhuis
Bergen op Zoom, 4600 AC, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, 1940 EB, Netherlands
IJsselland Ziekenhuis
Capelle aan den IJssel, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Catharina Ziekenhuis
Eindhoven, 5623 EJ, Netherlands
Medisch Spectrum Twente
Enschede, 7500 AN, Netherlands
St. Anna Ziekenhuis
Geldrop, Netherlands
Oosterscheldeziekenhuis
Goes, 4462 RA, Netherlands
Ziekenhuis Hilversum
Hilversum, 1213 XZ, Netherlands
Diaconessenhuis
Leiden, Netherlands
Rijnland Ziekenhuis
Leiderdorp, 2353 GA, Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, 3430 EM, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Erasmus MC
Rotterdam, 3015 GD, Netherlands
Havenziekenhuis
Rotterdam, Netherlands
Haga Ziekenhuis, location Leyweg
The Hague, 2545 CH, Netherlands
Bronovo Ziekenhuis
The Hague, 2597 AX, Netherlands
Haga Ziekenhuis, location Sportlaan
The Hague, Netherlands
Twee Steden Ziekenhuis
Tilburg, Netherlands
Maxima Medisch Centrum
Veldhoven, Netherlands
Alysis Ziekenhuis
Velp, Netherlands
Wageningen University, Division of Human Nutrition
Wageningen, 6700 EV, Netherlands
Zaans Medisch Centrum
Zaandam, 1502 DV, Netherlands
't Lange Land ziekenhuis
Zoetermeer, Netherlands
Isala Klinieken
Zwolle, 8011 JW, Netherlands
Related Publications (13)
Geleijnse JM, Giltay EJ, Schouten EG, de Goede J, Oude Griep LM, Teitsma-Jansen AM, Katan MB, Kromhout D; Alpha Omega Trial Group. 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. Am Heart J. 2010 Apr;159(4):539-546.e2. doi: 10.1016/j.ahj.2009.12.033.
PMID: 20362710BACKGROUNDLiu S, Soedamah-Muthu SS, van Meerten SC, Kromhout D, Geleijnse JM, Giltay EJ. Use of benzodiazepine and Z-drugs and mortality in older adults after myocardial infarction. Int J Geriatr Psychiatry. 2023 Jan;38(1):e5861. doi: 10.1002/gps.5861.
PMID: 36514248DERIVEDPertiwi K, Wanders AJ, Harbers MC, Kupers LK, Soedamah-Muthu SS, de Goede J, Zock PL, Geleijnse JM. Plasma and Dietary Linoleic Acid and 3-Year Risk of Type 2 Diabetes After Myocardial Infarction: A Prospective Analysis in the Alpha Omega Cohort. Diabetes Care. 2020 Feb;43(2):358-365. doi: 10.2337/dc19-1483. Epub 2019 Nov 14.
PMID: 31727685DERIVEDSijtsma FP, Soedamah-Muthu SS, de Goede J, Oude Griep LM, Geleijnse JM, Giltay EJ, de Boer MJ, Jacobs DR Jr, Kromhout D. Healthy eating and lower mortality risk in a large cohort of cardiac patients who received state-of-the-art drug treatment. Am J Clin Nutr. 2015 Dec;102(6):1527-33. doi: 10.3945/ajcn.115.112276. Epub 2015 Oct 21.
PMID: 26490494DERIVEDHoogeveen EK, Geleijnse JM, Kromhout D, Stijnen T, Gemen EF, Kusters R, Giltay EJ. Effect of omega-3 fatty acids on kidney function after myocardial infarction: the Alpha Omega Trial. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1676-83. doi: 10.2215/CJN.10441013. Epub 2014 Aug 7.
PMID: 25104273DERIVEDHoogeveen EK, Geleijnse JM, Kromhout D, van't Sant P, Gemen EF, Kusters R, Giltay EJ. No effect of n-3 fatty acids supplementation on NT-proBNP after myocardial infarction: the Alpha Omega Trial. Eur J Prev Cardiol. 2015 May;22(5):648-55. doi: 10.1177/2047487314536694. Epub 2014 May 30.
PMID: 24879357DERIVEDBrouwer IA, Geleijnse JM, Klaasen VM, Smit LA, Giltay EJ, de Goede J, Heijboer AC, Kromhout D, Katan MB. Effect of alpha linolenic acid supplementation on serum prostate specific antigen (PSA): results from the alpha omega trial. PLoS One. 2013 Dec 11;8(12):e81519. doi: 10.1371/journal.pone.0081519. eCollection 2013.
PMID: 24349086DERIVEDHoogeveen EK, Geleijnse JM, Kromhout D, Giltay EJ. No effect of n-3 fatty acids on high-sensitivity C-reactive protein after myocardial infarction: the Alpha Omega Trial. Eur J Prev Cardiol. 2014 Nov;21(11):1429-36. doi: 10.1177/2047487313494295. Epub 2013 Jun 17.
PMID: 23774275DERIVEDEussen 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. Eur Heart J. 2012 Jul;33(13):1582-8. doi: 10.1093/eurheartj/ehr499. Epub 2012 Feb 1.
PMID: 22301766DERIVEDKromhout D, Geleijnse JM, de Goede J, Oude Griep LM, Mulder BJ, de Boer MJ, Deckers JW, Boersma E, Zock PL, Giltay EJ. n-3 fatty acids, ventricular arrhythmia-related events, and fatal myocardial infarction in postmyocardial infarction patients with diabetes. Diabetes Care. 2011 Dec;34(12):2515-20. doi: 10.2337/dc11-0896.
PMID: 22110169DERIVEDGiltay EJ, Geleijnse JM, Kromhout D. Effects of n-3 fatty acids on depressive symptoms and dispositional optimism after myocardial infarction. Am J Clin Nutr. 2011 Dec;94(6):1442-50. doi: 10.3945/ajcn.111.018259. Epub 2011 Oct 26.
PMID: 22030221DERIVEDGeleijnse 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. Alzheimers Dement. 2012 Jul;8(4):278-87. doi: 10.1016/j.jalz.2011.06.002. Epub 2011 Oct 2.
PMID: 21967845DERIVEDKromhout D, Giltay EJ, Geleijnse JM; Alpha Omega Trial Group. n-3 fatty acids and cardiovascular events after myocardial infarction. N Engl J Med. 2010 Nov 18;363(21):2015-26. doi: 10.1056/NEJMoa1003603. Epub 2010 Aug 28.
PMID: 20929341DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daan Kromhout, PhD MPH
Wageningen University, The Netherlands
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 3, 2005
First Posted
August 5, 2005
Study Start
April 1, 2002
Primary Completion
November 1, 2009
Study Completion
June 1, 2010
Last Updated
July 7, 2010
Record last verified: 2010-07