This trial is active, not recruiting.

Conditions atrial fibrillation, diet therapy
Treatment ala rich diet
Phase phase 2
Sponsor University of Toronto
Collaborator University Hospital, Bordeaux
Start date June 1999
End date June 2003
Trial size 130 participants
Trial identifier NCT00410839, 99-04 (CPPRB Bordeaux B)


An alpha-linolenic acid (ALA) rich diet in the Lyon Heart Study reduced sudden cardiac deaths possibly by reducing cardiac arrhythmias and ventricular fibrillation (Lancet 1994). Since then, there has been a growing interest in ALA as a cardioprotective nutrient. Much of the interest has focused on the potential antiarrhythmic effect of ω-3 fatty acids, especially the longer chain ω-3 fatty acids, DHA and EPA, derived from fish. We therefore concluded it important to test whether the shorter chain ω-3 vegetable oil ALA also had antiarrhythmic effects, since this might also explain the beneficial effects seen on cardiovascular mortality in the Lyon Heart Study.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

rate of recurrence and length of time to first recurrence of atrial fibrillation.
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 77 years old.

Inclusion Criteria: - patients hospitalized in one of the three centers in the Bordeaux region, and who subsequently underwent successful electrocardioversion for atrial fibrillation. Exclusion Criteria: - included patients who were unable to receive electrocardioversion or those who were already enrolled in another trial - patients who were unable or unwilling to comply with the diet recommendations (experimental or control) or follow-up requirements - patients with clinically significant cardiac disease, advanced heart failure, cardiac cachexia, thyroid disease, treated or untreated, clinically significant hepatic or renal disease or a history of malignant disease or alcohol abuse were not included - 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.

Additional Information

Official title Prevention of Atrial Fibrillation Recurrence By An Alpha-Linolenic Enriched Diet - A Pilot Study
Principal investigator Serge Renaud, MD, PhD
Description Objective: We determined the effect of an ALA rich diet in reducing recurrence of atrial fibrillation as a further example of a cardiac arrhythmia. Design: Randomized parallel design efficacy study. Setting: Three university hospital centers in the Bordeaux region, France. Patients: 98 successive patients successfully underwent electro cardioversion of whom 75 completed the study without major deviations according to the protocol. Intervention: A canola margarine and oil together with a Mediterranean diet (ALA ω-3, 1.4 g/d) 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2006.
Information provided to ClinicalTrials.gov by University of Toronto.