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Status unknownNCT00410839Updated Dec 13, 2006

Studies of the Prevention of Atrial Fibrillation by ALA

A Phase 2 interventional study of ALA rich diet in Atrial Fibrillation and Diet Therapy, sponsored by University of Toronto. Status unknown at 1 site in France. Open to participants aged 18 Years to 77 Years. Per ClinicalTrials.gov, last updated 2006-12-13.

Sponsored by University of Toronto · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2004), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 77 Years
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Atrial Fibrillation
  • Diet Therapy

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 130 is close to the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

University of Toronto is the lead sponsor of 397 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 77 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants

Interventions

  • ProcedureALA rich diet
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What researchers measure

Primary outcomes

  1. rate of recurrence and length of time to first recurrence of atrial fibrillation.

07

Study locations

1 site
  • Emile Roux Hospital
    Paris, 94456, France
08

References and documents

Publications

  • 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. Erratum In: Lancet 1995 Mar 18;345(8951):738. PubMed 7911176 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00410839
Lead sponsor
University of Toronto
Collaborators
University Hospital, Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France
First posted
Dec 13, 2006
Start date
Jun 1999
Completion
Jun 2003
Last update
Dec 13, 2006

Study contacts

Serge Renaud, MD, PhD
principal investigator · Emile Roux Hospital, A.P.H. Paris, 94456 Limeil-Brevannes, France
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2004. You cannot join it, but the record below documents what was studied.

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