Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet
NCT ID: NCT00410020
Last Updated: 2006-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
130 participants
INTERVENTIONAL
1999-06-30
2003-06-30
Brief Summary
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Since then, there has been a growing interest in ALA, ω-3 fatty acid family precursor, as a cardioprotective nutrient. Much of the interest has focused on the potential antiarrhythmic effect of longer chain ω-3 fatty acids, DHA and EPA, derived from fish.
We therefore concluded it important to test wether vegetable source ω-3 also had antiarrhythmic effects, as shown in animals by Leaf and McLennan, since this might also explain the beneficial effects seen on cardiovascular mortality in the Lyon Diet Heart Study.
Detailed Description
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Design: Randomized parallel design efficacy study.
Setting: Three university hospital centers in the Bordeaux region, France.
Patients: 98 patients randomized immediately after successful atrial fibrillation electrical cardioversion.
Intervention: A canola margarine and oil, versus a conventional diet (control), with a one year follow-up.
Main outcome measure: Length of time to first recurrence of atrial fibrillation.
Significance: If ALA is antiarrhythmic, this action may explain its cardioprotective effect in clinical trials and cohort studies.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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Alpha-linolenic enriched diet
Eligibility Criteria
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Inclusion Criteria
* clinical diagnosis of atrial fibrillation
* who subsequently underwent successful electrical cardioversion
Exclusion Criteria
* already enrolled in another trial
* unable or unwilling to comply with the diet recommendations (experimental or control) or follow-up requirements
* clinically significant cardiac disease, advanced heart failure, cardiac cachexia
* thyroid disease, treated or untreated,
* clinically significant hepatic or renal disease
* history of malignant disease
* alcohol abuse
* taking ALA rich foods or recording intakes of ALA \>2g/d on the control diet or reporting using \<1g/d on the ALA diet was considered a major deviation from the protocol
18 Years
77 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Principal Investigators
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Jean-Paul Broustet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitary Hospital Haut-Lévêque Bordeaux France
Serge C Renaud, VMD, PhD
Role: STUDY_CHAIR
Bordeaux2 University
Dominique Lanzmann-Petithory, MD, PhD
Role: STUDY_DIRECTOR
Bordeaux2 University - Paris AP Hospitals
Locations
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Girac Hospital
Angoulême, , France
Hôpital du Haut-Lévêque
Bordeaux, , France
Robert Boulin Hospital
Libourne, , France
Countries
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References
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de Lorgeril M, Renaud S, Mamelle N, Salen P, Martin JL, Monjaud I, Guidollet J, Touboul P, Delaye J. Mediterranean alpha-linolenic acid-rich diet in secondary prevention of coronary heart disease. Lancet. 1994 Jun 11;343(8911):1454-9. doi: 10.1016/s0140-6736(94)92580-1.
Renaud S, de Lorgeril M, Delaye J, Guidollet J, Jacquard F, Mamelle N, Martin JL, Monjaud I, Salen P, Toubol P. Cretan Mediterranean diet for prevention of coronary heart disease. Am J Clin Nutr. 1995 Jun;61(6 Suppl):1360S-1367S. doi: 10.1093/ajcn/61.6.1360S.
Renaud S, Nordoy A. "Small is beautiful": alpha-linolenic acid and eicosapentaenoic acid in man. Lancet. 1983 May 21;1(8334):1169. doi: 10.1016/s0140-6736(83)92902-1. No abstract available.
Lanzmann-Petithory D, Pueyo S, Renaud S. Primary prevention of cardiovascular diseases by alpha-linolenic acid. Am J Clin Nutr. 2002 Dec;76(6):1456; author reply 1456-7. doi: 10.1093/ajcn/76.6.1456. No abstract available.
Renaud SC, Lanzmann-Petithory D. alpha-linolenic acid in the prevention of cardiovascular diseases. World Rev Nutr Diet. 2001;88:79-85. doi: 10.1159/000059769. No abstract available.
Renaud SC, Lanzmann-Petithory D. The beneficial effect of alpha-linolenic acid in coronary artery disease is not questionable. Am J Clin Nutr. 2002 Oct;76(4):903-4; author reply 904-6. doi: 10.1093/ajcn/76.4.903. No abstract available.
Singh RB, Dubnov G, Niaz MA, Ghosh S, Singh R, Rastogi SS, Manor O, Pella D, Berry EM. Effect of an Indo-Mediterranean diet on progression of coronary artery disease in high risk patients (Indo-Mediterranean Diet Heart Study): a randomised single-blind trial. Lancet. 2002 Nov 9;360(9344):1455-61. doi: 10.1016/S0140-6736(02)11472-3.
Lanzmann-Petithory D. Alpha-linolenic acid and cardiovascular diseases. J Nutr Health Aging. 2001;5(3):179-83.
Kang JX, Leaf A. Protective effects of free polyunsaturated fatty acids on arrhythmias induced by lysophosphatidylcholine or palmitoylcarnitine in neonatal rat cardiac myocytes. Eur J Pharmacol. 1996 Feb 15;297(1-2):97-106. doi: 10.1016/0014-2999(95)00701-6.
McLennan PL, Dallimore JA. Dietary canola oil modifies myocardial fatty acids and inhibits cardiac arrhythmias in rats. J Nutr. 1995 Apr;125(4):1003-9. doi: 10.1093/jn/125.4.1003.
Other Identifiers
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99-04 (CPPRB BORDEAUX B)
Identifier Type: -
Identifier Source: secondary_id
DGS 990321
Identifier Type: -
Identifier Source: org_study_id