Working… Menu
Trial record 23 of 34 for:    alpha | linolenic acid

Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00410020
Recruitment Status : Completed
First Posted : December 12, 2006
Last Update Posted : December 12, 2006
University Hospital, Bordeaux
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Diet Therapy Behavioral: Alpha-linolenic enriched diet Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Secondary Prevention of Atrial Fibrillation With an Alpha-Linolenic Enriched Diet : a Randomized Study
Study Start Date : June 1999
Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Rate of recurrence on periods
  2. Length of time to first recurrence of atrial fibrillation

Secondary Outcome Measures :
  1. subgroup analysis (high blood pressure, non persistent atrial fibrillation)
  2. comparison between late and early recurrence (before or after 14 days)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients hospitalized in one of the three centers in the Bordeaux region
  • clinical diagnosis of atrial fibrillation
  • who subsequently underwent successful electrical cardioversion

Exclusion Criteria:

  • unable to receive electrical cardioversion
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00410020

Layout table for location information
Girac Hospital
Angouleme, France, 16470
Hôpital du Haut-Lévêque
Bordeaux, France, 33604
Robert Boulin Hospital
Libourne, France, 33500
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
University Hospital, Bordeaux
Layout table for investigator information
Principal Investigator: Jean-Paul Broustet, MD, PhD Universitary Hospital Haut-Lévêque Bordeaux France
Study Chair: Serge C Renaud, VMD, PhD Bordeaux2 University
Study Director: Dominique Lanzmann-Petithory, MD, PhD Bordeaux2 University - Paris AP Hospitals


Layout table for additonal information Identifier: NCT00410020     History of Changes
Other Study ID Numbers: DGS 990321
First Posted: December 12, 2006    Key Record Dates
Last Update Posted: December 12, 2006
Last Verified: December 2006
Keywords provided by Assistance Publique - Hôpitaux de Paris:
alpha linolenic acid
atrial fibrillation
omega 3 fatty acids
rapeseed oil
canola oil
cardiovascular diseases
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes