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
Copyright 2010 Mosby, Inc. All rights reserved..
BACKGROUND: Weekly fish consumption has been related to a lower risk of fatal coronary heart disease (CHD) and incident stroke in populations with a low fish intake. This relation has mainly been attributed to n-3 fatty acids in fish, that is, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). It is at present unclear whether alpha-linolenic acid (ALA), a n-3 fatty acid from vegetable origin, could also be protective against cardiovascular diseases (CVDs). There is a need for food-based trials to establish the efficacy of low doses of n-3 fatty acids in CVD prevention.
OBJECTIVES: The aim of the study was to evaluate the effect of an additional daily intake of 400 mg of EPA + DHA and 2 g of ALA on CVD morbidity and mortality in free-living subjects with a history of myocardial infarction.
DESIGN: The multicenter Alpha Omega Trial is a randomized, double-blind, placebo-controlled trial with a 2 x 2 factorial design. Between May 2002 and December 2006, we enrolled a total of 4,837 men and women aged 60 through 80 who experienced a myocardial infarction within 10 years before entering the study. Subjects were randomized to 1 of 4 margarine spreads that were enriched with EPA + DHA and/or ALA, or placebo. Compliance was monitored via tub counts and assessment of n-3 fatty acids in plasma. Subjects were observed for 40 months for the occurrence of fatal and nonfatal CVD.
RESULTS: The cohort was on average 69 years old at the start of the study and comprised 22% women. Subjects had their (last) myocardial infarction approximately 4 years before enrollment. Mean body mass index was 27.7 kg/m(2), and 17% smoked. Average serum total and high-density lipoprotein cholesterol were 4.7 and 1.3 mmol/L, respectively, and 85% used statins. Mean blood pressure was 142/80 mm Hg, and most subjects were on antihypertensive medication (88%). Diabetes mellitus was reported by 17% of the subjects, and 7% reported a history of stroke. The overall mortality rate during the trial period was 23 per 1,000 person-years, with approximately 40% due to CVD.
CURRENT STATUS: Follow-up of the patients was completed in November 2009, and findings will be reported in the second part of 2010.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2010 |
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| Erschienen: |
2010 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:159 |
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| Enthalten in: |
American heart journal - 159(2010), 4 vom: 31. Apr., Seite 539-546.e2 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Geleijnse, Johanna M [VerfasserIn] |
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| Links: |
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| Themen: |
Fatty Acids, Omega-3 |
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| Anmerkungen: |
Date Completed 13.05.2010 Date Revised 18.03.2022 published: Print ClinicalTrials.gov: NCT00127452 Citation Status MEDLINE |
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| doi: |
10.1016/j.ahj.2009.12.033 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM197070892 |
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| 100 | 1 | |a Geleijnse, Johanna M |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Effect of low doses of n-3 fatty acids on cardiovascular diseases in 4,837 post-myocardial infarction patients |b design and baseline characteristics of the Alpha Omega Trial |
| 264 | 1 | |c 2010 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 13.05.2010 | ||
| 500 | |a Date Revised 18.03.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT00127452 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright 2010 Mosby, Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: Weekly fish consumption has been related to a lower risk of fatal coronary heart disease (CHD) and incident stroke in populations with a low fish intake. This relation has mainly been attributed to n-3 fatty acids in fish, that is, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). It is at present unclear whether alpha-linolenic acid (ALA), a n-3 fatty acid from vegetable origin, could also be protective against cardiovascular diseases (CVDs). There is a need for food-based trials to establish the efficacy of low doses of n-3 fatty acids in CVD prevention | ||
| 520 | |a OBJECTIVES: The aim of the study was to evaluate the effect of an additional daily intake of 400 mg of EPA + DHA and 2 g of ALA on CVD morbidity and mortality in free-living subjects with a history of myocardial infarction | ||
| 520 | |a DESIGN: The multicenter Alpha Omega Trial is a randomized, double-blind, placebo-controlled trial with a 2 x 2 factorial design. Between May 2002 and December 2006, we enrolled a total of 4,837 men and women aged 60 through 80 who experienced a myocardial infarction within 10 years before entering the study. Subjects were randomized to 1 of 4 margarine spreads that were enriched with EPA + DHA and/or ALA, or placebo. Compliance was monitored via tub counts and assessment of n-3 fatty acids in plasma. Subjects were observed for 40 months for the occurrence of fatal and nonfatal CVD | ||
| 520 | |a RESULTS: The cohort was on average 69 years old at the start of the study and comprised 22% women. Subjects had their (last) myocardial infarction approximately 4 years before enrollment. Mean body mass index was 27.7 kg/m(2), and 17% smoked. Average serum total and high-density lipoprotein cholesterol were 4.7 and 1.3 mmol/L, respectively, and 85% used statins. Mean blood pressure was 142/80 mm Hg, and most subjects were on antihypertensive medication (88%). Diabetes mellitus was reported by 17% of the subjects, and 7% reported a history of stroke. The overall mortality rate during the trial period was 23 per 1,000 person-years, with approximately 40% due to CVD | ||
| 520 | |a CURRENT STATUS: Follow-up of the patients was completed in November 2009, and findings will be reported in the second part of 2010 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Fatty Acids, Omega-3 |2 NLM | |
| 700 | 1 | |a Giltay, Erik J |e verfasserin |4 aut | |
| 700 | 1 | |a Schouten, Evert G |e verfasserin |4 aut | |
| 700 | 1 | |a de Goede, Janette |e verfasserin |4 aut | |
| 700 | 1 | |a Oude Griep, Linda M |e verfasserin |4 aut | |
| 700 | 1 | |a Teitsma-Jansen, Anna M |e verfasserin |4 aut | |
| 700 | 1 | |a Katan, Martijn B |e verfasserin |4 aut | |
| 700 | 1 | |a Kromhout, Daan |e verfasserin |4 aut | |
| 700 | 0 | |a Alpha Omega Trial Group |e verfasserin |4 aut | |
| 700 | 1 | |a Kromhout, D |e investigator |4 oth | |
| 700 | 1 | |a Schouten, E G |e investigator |4 oth | |
| 700 | 1 | |a Geleijnse, J M |e investigator |4 oth | |
| 700 | 1 | |a Giltay, E J |e investigator |4 oth | |
| 700 | 1 | |a de Goede, J |e investigator |4 oth | |
| 700 | 1 | |a Oude Griep, L M |e investigator |4 oth | |
| 700 | 1 | |a Teitsma-Jansen, A |e investigator |4 oth | |
| 700 | 1 | |a Mulder, B J M |e investigator |4 oth | |
| 700 | 1 | |a Deckers, J W |e investigator |4 oth | |
| 700 | 1 | |a Katan, M B |e investigator |4 oth | |
| 700 | 1 | |a Zock, P L |e investigator |4 oth | |
| 700 | 1 | |a de Boer, M J |e investigator |4 oth | |
| 700 | 1 | |a de Leeuw, H |e investigator |4 oth | |
| 700 | 1 | |a Schouten, E G |e investigator |4 oth | |
| 700 | 1 | |a Zock, P L |e investigator |4 oth | |
| 700 | 1 | |a Boersma, E |e investigator |4 oth | |
| 700 | 1 | |a Jukema, J W |e investigator |4 oth | |
| 700 | 1 | |a van Binsbergen, J J |e investigator |4 oth | |
| 700 | 1 | |a van der Kuip, D A M |e investigator |4 oth | |
| 700 | 1 | |a Thomas, K |e investigator |4 oth | |
| 700 | 1 | |a Rivero-Ayerza, M |e investigator |4 oth | |
| 700 | 1 | |a Vollaard, A M |e investigator |4 oth | |
| 700 | 1 | |a Fieren, C J |e investigator |4 oth | |
| 700 | 1 | |a van Kempen, L H J |e investigator |4 oth | |
| 700 | 1 | |a Bakx, A |e investigator |4 oth | |
| 700 | 1 | |a Sedney, M I |e investigator |4 oth | |
| 700 | 1 | |a Hertzberger, D P |e investigator |4 oth | |
| 700 | 1 | |a Michels, H R |e investigator |4 oth | |
| 700 | 1 | |a de Rotte, A A |e investigator |4 oth | |
| 700 | 1 | |a van Rugge, R P |e investigator |4 oth | |
| 700 | 1 | |a Klootwijk, A |e investigator |4 oth | |
| 700 | 1 | |a Verheul, J A |e investigator |4 oth | |
| 700 | 1 | |a Nicastia, D M |e investigator |4 oth | |
| 700 | 1 | |a Robles de Medina, R |e investigator |4 oth | |
| 700 | 1 | |a van Rossem, M |e investigator |4 oth | |
| 700 | 1 | |a Leenders, C M |e investigator |4 oth | |
| 700 | 1 | |a de Boer, M J |e investigator |4 oth | |
| 700 | 1 | |a van der Meer, P |e investigator |4 oth | |
| 700 | 1 | |a Uppal, S C |e investigator |4 oth | |
| 700 | 1 | |a Blok, J G |e investigator |4 oth | |
| 700 | 1 | |a Visser, R F |e investigator |4 oth | |
| 700 | 1 | |a Mosterd, A |e investigator |4 oth | |
| 700 | 1 | |a Umans, V A W M |e investigator |4 oth | |
| 700 | 1 | |a Reichert, C L A |e investigator |4 oth | |
| 700 | 1 | |a Louwerenburg, J W |e investigator |4 oth | |
| 700 | 1 | |a Liem, A H |e investigator |4 oth | |
| 700 | 1 | |a van Rees, C |e investigator |4 oth | |
| 700 | 1 | |a Kirchhof, C J H J |e investigator |4 oth | |
| 700 | 1 | |a Konst, L |e investigator |4 oth | |
| 700 | 1 | |a Drost, H |e investigator |4 oth | |
| 700 | 1 | |a van Liebergen, R A M |e investigator |4 oth | |
| 700 | 1 | |a Polak, P E |e investigator |4 oth | |
| 700 | 1 | |a Plokker, H W M |e investigator |4 oth | |
| 700 | 1 | |a Schroeder-Tanka, J |e investigator |4 oth | |
| 700 | 1 | |a van Kesteren, H |e investigator |4 oth | |
| 700 | 1 | |a van den Berg, B J |e investigator |4 oth | |
| 700 | 1 | |a Bronzwaer, P N A |e investigator |4 oth | |
| 700 | 1 | |a van Loenhout, T T |e investigator |4 oth | |
| 700 | 1 | |a de Milliano, P |e investigator |4 oth | |
| 700 | 1 | |a Jansen, E H J M |e investigator |4 oth | |
| 700 | 1 | |a Grootaarts, W |e investigator |4 oth | |
| 700 | 1 | |a van Rumpt, D |e investigator |4 oth | |
| 700 | 1 | |a Hulshof, P J M |e investigator |4 oth | |
| 700 | 1 | |a de Vries, J H M |e investigator |4 oth | |
| 700 | 1 | |a Rosier, O E |e investigator |4 oth | |
| 700 | 1 | |a Zevenbergen, J L |e investigator |4 oth | |
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