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Cardiovascular DiseasesNCT00127452

Alpha Omega Trial: Study of Omega-3 Fatty Acids and Coronary Mortality

A study testing margarine spread in people with Cardiovascular Diseases, run by Wageningen University at 32 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Cardiovascular Diseases
What is being tested?
margarine spread
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,837 participants
Where
32 sitesNetherlands
Study dates
Apr 2002to Jun 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women
  • Aged 60 through 80 y
  • Verified clinically diagnosed myocardial infarction up to 10 y before randomization
  • Written informed consent

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Netherlands32 sites

  • Medisch Centrum Alkmaar

    Alkmaar, 1815 JD

  • Flevo Ziekenhuis

    Almere Stad, 1315 RA

  • Meander Medisch Centrum

    Amersfoort, 3800 BM

  • Sint Lucas Andreas Ziekenhuis

    Amsterdam, 1006 AE

  • BovenIJ Ziekenhuis

    Amsterdam, 1034 CS

  • Slotervaartziekenhuis

    Amsterdam, 1066 EC

  • Gelre ziekenhuizen

    Apeldoorn

  • Lievensberg Ziekenhuis

    Bergen op Zoom, 4600 AC

  • Rode Kruis Ziekenhuis

    Beverwijk, 1940 EB

  • IJsselland Ziekenhuis

    Capelle aan den IJssel

  • Ziekenhuis Gelderse Vallei

    Ede

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ

  • Medisch Spectrum Twente

    Enschede, 7500 AN

  • St. Anna Ziekenhuis

    Geldrop

  • Oosterscheldeziekenhuis

    Goes, 4462 RA

  • Ziekenhuis Hilversum

    Hilversum, 1213 XZ

  • Diaconessenhuis

    Leiden

  • Rijnland Ziekenhuis

    Leiderdorp, 2353 GA

  • Sint Antonius Ziekenhuis

    Nieuwegein, 3430 EM

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen

  • Erasmus MC

    Rotterdam, 3015 GD

  • Havenziekenhuis

    Rotterdam

  • Haga Ziekenhuis, location Leyweg

    The Hague, 2545 CH

  • Bronovo Ziekenhuis

    The Hague, 2597 AX

  • Haga Ziekenhuis, location Sportlaan

    The Hague

  • Twee Steden Ziekenhuis

    Tilburg

  • Maxima Medisch Centrum

    Veldhoven

  • Alysis Ziekenhuis

    Velp

  • Wageningen University, Division of Human Nutrition

    Wageningen, 6700 EV

  • Zaans Medisch Centrum

    Zaandam, 1502 DV

  • 't Lange Land ziekenhuis

    Zoetermeer

  • Isala Klinieken

    Zwolle, 8011 JW

Other trials in Netherlands

About this study

Official title: 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

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.
Read the detailed description

Whether dietary omega-3 (or n-3) polyunsaturated fatty acids are causally related to risk of cardiovascular diseases (CVD) is a major, unresolved question in preventive cardiology. Essential n-3 fatty acids are eicosapentaenoic acid (EPA; C20:5, n-3) and docosahexaenoic acid (DHA; C22:6, n-3) on one hand, and their parent compound alpha-linolenic acid (ALA; C18:3, n-3) on the other hand. The intake of n-3 fatty acids is below recommended levels in most Western populations. The Alpha Omega Trial is a randomized, double-blind, placebo-controlled study of the effect of low-dose supplementation of ALA and EPA-DHA on CVD. A total of 4837 Dutch men and women aged 60-80 years who had a myocardial infarction in the past 10 years are randomly allocated to 2 g/d of ALA, 400 mg/d of EPA-DHA, 2 g/d ALA + 400 mg/d EPA-DHA, or placebo, for 40 months. Increased intake of n-3 fatty acids is achieved through daily use of 20 g of margarine on bread. Margarines for all treatment groups are similar in taste and appearance. The primary outcome of the trial is 'major cardiovascular events', which comprises incident CVD and cardiac interventions (PCI and CABG) during follow-up. Secondary endpoints are incident CVD, fatal CVD, fatal CHD and all-causes mortality. Complete follow-up for vital status is achieved. Cause-specific mortality is coded by an independent Endpoint Adjudication Committee. Physical examination, blood sampling and data collection on diet and lifestyle are performed in all subjects at baseline, in 810 randomly selected subjects after 20 months of intervention, and in 58% of the cohort at the end of follow-up. Cardiovascular health, serious adverse events, lifestyle, fish intake and margarine use are monitored in all subjects by yearly telephone interviews. Compliance is continuously monitored by registration of margarine tubs. An objective biomarker of compliance (i.e. plasma n-3 fatty acids) is obtained in randomly selected subjects at baseline and after 20 and 40 months of intervention. The Alpha Omega Trial could provide a sound scientific basis for dietary recommendations on intake of ALA and EPA-DHA, in order to reduce the burden of cardiovascular diseases.

Being tested
margarine spread
Keywords
alpha-linolenic acid, cardiovascular diseases, coronary heart disease, coronary patients, DHA, dietary intervention, dietary supplementation, docosahexaenoic acid, eicosapentaenoic acid, EPA, fish oil, fish fatty acids, human subjects, ischaemic heart disease, margarine, marine fatty acids, mortality, myocardial infarction, n-3 fatty acids, n-3 polyunsaturated fatty acids
Medical subject headings
Cardiovascular Diseases, Coronary Disease, Coronary Artery Disease, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • margarine spreadDietary supplement

    Daily use of margarine spread (approximately 20 grams) during 40 months

Study groups in NCT00127452
Study groupRoleWhat they receive
EPA + DHAExperimentalMargarine spread that yields 400 mg of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) per day for average margarine use of 20 grams per day
Receives: Dietary Supplement: margarine spread
ALAExperimentalMargarine spread that yields 2 grams of alpha-linolenic acid (ALA) per day for average margarine use of 20 grams per day
Receives: Dietary Supplement: margarine spread
EPA + DHA plus ALAExperimentalMargarine 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
Receives: Dietary Supplement: margarine spread
PlaceboPlacebo comparatorMargarine spread that contains no EPA, DHA or ALA (exchanged for oleic acid)
Receives: Dietary Supplement: margarine spread

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: monitored during intervention

Secondary outcomes (6)

  1. Incident CVD, which comprises fatal CVD, non-fatal myocardial infarction, non-fatal cardiac arrest and non-fatal stroke

    Measured: monitored during intervention

  2. Fatal CVD, which comprises mortality from ischaemic heart disease, fatal cardiac arrest, sudden death undefined, mortality from heart failure and fatal stroke

    Measured: monitored during intervention

  3. Fatal CHD, which comprises mortality from ischaemic heart disease, mortality from cardiac arrest, and sudden death undefined

    Measured: monitored during intervention

  4. All-causes mortality

    Measured: monitored during intervention

  5. The composite of sudden death undefined and nonfatal and fatal cardiac arrest

    Measured: monitored during intervention

  6. The composite of sudden death undefined, nonfatal and fatal cardiac arrest, and self-reported placement of any implantable cardioverter-defibrillator, verified in medical records

    Measured: monitored during intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2005 (estimated)
  2. Study startApr 2002
  3. Primary completionNov 2009
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,837 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00127452
Sponsor's protocol ID
METC-ZWH 0552
Other IDs
NHF-2000T401, L01.049, 5R01HL076200
Status last verified
Jul 2010
First submitted
3 Aug 2005
Last updated
7 Jul 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20362710

  • Liu 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.

    PubMed 36514248

  • Pertiwi 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.

    PubMed 31727685

  • Sijtsma 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.

    PubMed 26490494

  • Hoogeveen 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.

    PubMed 25104273

  • Hoogeveen 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.

    PubMed 24879357

  • Brouwer 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.

    PubMed 24349086

  • Hoogeveen 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.

    PubMed 23774275

  • 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. Eur Heart J. 2012 Jul;33(13):1582-8. doi: 10.1093/eurheartj/ehr499. Epub 2012 Feb 1.

    PubMed 22301766

  • Kromhout 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.

    PubMed 22110169

  • Giltay 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.

    PubMed 22030221

  • 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. Alzheimers Dement. 2012 Jul;8(4):278-87. doi: 10.1016/j.jalz.2011.06.002. Epub 2011 Oct 2.

    PubMed 21967845

  • Kromhout 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.

    PubMed 20929341

Questions about this trial

What is this clinical trial studying?

A study testing margarine spread in people with Cardiovascular Diseases, run by Wageningen University at 32 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: monitored during intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00127452, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2010.

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