Alpha Omega Trial: Study of Omega-3 Fatty Acids and Coronary Mortality
- Conditions
- Cardiovascular Diseases
- Interventions
- Dietary Supplement: margarine spread
- Registration Number
- NCT00127452
- Lead Sponsor
- Wageningen University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4837
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EPA + DHA margarine spread Margarine spread that yields 400 mg of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) per day for average margarine use of 20 grams per day ALA margarine spread Margarine 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 margarine spread Margarine 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 margarine spread Margarine spread that contains no EPA, DHA or ALA (exchanged for oleic acid)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 The composite of sudden death undefined, nonfatal and fatal cardiac arrest, and self-reported placement of any implantable cardioverter-defibrillator, verified in medical records monitored during intervention
Trial Locations
- Locations (32)
Slotervaartziekenhuis
🇳🇱Amsterdam, Netherlands
Ziekenhuis Gelderse Vallei
🇳🇱Ede, Netherlands
Twee Steden Ziekenhuis
🇳🇱Tilburg, Netherlands
Flevo Ziekenhuis
🇳🇱Almere, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Wageningen University, Division of Human Nutrition
🇳🇱Wageningen, Netherlands
't Lange Land ziekenhuis
🇳🇱Zoetermeer, Netherlands
Isala Klinieken
🇳🇱Zwolle, Netherlands
Gelre ziekenhuizen
🇳🇱Apeldoorn, Netherlands
Maxima Medisch Centrum
🇳🇱Veldhoven, Netherlands
Meander Medisch Centrum
🇳🇱Amersfoort, Netherlands
Sint Lucas Andreas Ziekenhuis
🇳🇱Amsterdam, Netherlands
Havenziekenhuis
🇳🇱Rotterdam, Netherlands
Haga Ziekenhuis, location Sportlaan
🇳🇱The Hague, Netherlands
BovenIJ Ziekenhuis
🇳🇱Amsterdam, Netherlands
Diaconessenhuis
🇳🇱Leiden, Netherlands
Bronovo Ziekenhuis
🇳🇱The Hague, Netherlands
Medisch Centrum Alkmaar
🇳🇱Alkmaar, Netherlands
Lievensberg Ziekenhuis
🇳🇱Bergen op Zoom, Netherlands
Rode Kruis Ziekenhuis
🇳🇱Beverwijk, Netherlands
IJsselland Ziekenhuis
🇳🇱Capelle aan den IJssel, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
St. Anna Ziekenhuis
🇳🇱Geldrop, Netherlands
Oosterscheldeziekenhuis
🇳🇱Goes, Netherlands
Ziekenhuis Hilversum
🇳🇱Hilversum, Netherlands
Rijnland Ziekenhuis
🇳🇱Leiderdorp, Netherlands
Zaans Medisch Centrum
🇳🇱Zaandam, Netherlands
Sint Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Canisius Wilhelmina Ziekenhuis
🇳🇱Nijmegen, Netherlands
Erasmus MC
🇳🇱Rotterdam, Netherlands
Haga Ziekenhuis, location Leyweg
🇳🇱The Hague, Netherlands
Alysis Ziekenhuis
🇳🇱Velp, Netherlands