Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT00410020
Status:
COMPLETED
Last Update Posted:
2006-12-12
First Post:
2006-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Secondary Prevention of Atrial Fibrillation With an Alpha-Linolenic Enriched Diet : a Randomized Study
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An alpha linolenic acid (ALA) rich diet in the Lyon Diet 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, 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.
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:
Objective: To determine 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 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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 99-04 (CPPRB BORDEAUX B) | None | None | View |