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Alpha-linolenic Acid and the Risk of ASCVD

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ClinicalTrials.gov Identifier: NCT03258983
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by (Responsible Party):
Christian Sørensen Bork, Aalborg Universitetshospital

Brief Summary:

Background: The plant-derived omega-3 fatty acid alpha-linolenic acid (ALA, 18:3-n-3) may reduce the risk of atherosclerotic cardiovascular disease, including incident myocardial infarction, ischemic stroke and peripheral artery disease. However, the results of previous studies have been inconsistent.

Objectives: To investigate the associations between dietary intake of ALA, adipose tissue content of ALA, and the risk of the major atherosclerotic cardiovascular diseases incident myocardial infarction, ischemic stroke and subtypes, and peripheral artery disease.

Methods: This project will be based on data from the Danish cohort study Diet, Cancer and Health which consisted of 57,053 men and women at recruitment between 1993 and 1997. Dietary intake of ALA will be assessed using a validated semiquantitative food-frequency questionnaire and adipose tissue content will be determined with the use of gas chromatography analyses of adipose tissue biopsies collected at baseline. Also, detailed information on lifestyle factors, medical history and anthropometri was collected at baseline.

Incident cases have been identified through national registries and the diagnoses have previously been validated.

Analyses of dietary intake of ALA will be analysed using a traditional cohort design, whereas analyses on adipose tissue content of ALA will be analysed based on a case-cohort design. Hazard ratioes with 95% confidence intervals will be used to describe the associations between the exposure variables and the outcome variables of interest.


Condition or disease Intervention/treatment
Acute Myocardial Infarction Ischemic Stroke Peripheral Artery Disease Other: Alpha-linolenic acid

Study Type : Observational
Actual Enrollment : 57053 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alpha-linolenic Acid and the Risk of Atherosclerotic Cardiovascular Disease
Actual Study Start Date : November 24, 1993
Actual Primary Completion Date : July 10, 2013
Actual Study Completion Date : July 10, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort Intervention/treatment
The Diet, Cancer and Health cohort Other: Alpha-linolenic acid
Exposure to dietary intake of alpha-linolenic acid (ALA) will be assessed using a detailed food frequency questionaire filled in by participants included in the Diet, Cancer and Health cohort at baseline. Exposure to adipose tissue content of ALA will be determined by gas chromatography in all incident cases and in subcohort of 3500 participants randomly drawn from the total cohort.
Other Name: ALA (18:3-n3)




Primary Outcome Measures :
  1. Incident acute myocardial infarction [ Time Frame: From baseline until July 2013 ]
  2. Incident ischemic stroke including total and subtypes of ischemic stroke [ Time Frame: From baseline until November 2009 ]
  3. Incident peripheral artery disease [ Time Frame: From baseline until December 2009 ]

Secondary Outcome Measures :
  1. Incident fatal myocardial infarction [ Time Frame: From baseline until July 2013 ]

Biospecimen Retention:   Samples With DNA
Subcutaneous adipose tissue, serum, plasma, ''buffycoat'', erytrocytes and urine is stored in nitrogen vapour at the biobank of the Diet, Cancer and Health cohort study. Also, whole blood in filter paper and toenail clippings has been stored within the biobank.


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Ages Eligible for Study:   50 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population

The Diet, Cancer and Health cohort was established over a period of 3.5 years between 1993 and 1997 by inviting 160,725 men and women to participate. All eligible participants were native Danish citizens without a previous diagnosis of cancer, aged 50-64 years, and living in the areas of Copenhagen and Aarhus. A total of 57053 accepted to participate in the Diet, Cancer and Health cohort study.

A subcohort of 3500 participants were drawn randomly from the cohort at baseline.

Criteria

Inclusion Criteria:

  • Born in Denmark
  • Age between 50 and 64 years
  • Living in the areas of Copenhagen and Aarhus

Exclusion Criteria:

  • Previous cancer

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 ClinicalTrials.gov identifier (NCT number): NCT03258983


Sponsors and Collaborators
Aalborg Universitetshospital
Danish Heart Foundation
Investigators
Principal Investigator: Christian S Bork, MD Department of Cardiology, Aalborg University Hospital, Denmark

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Sørensen Bork, Dr. Christian Sørensen Bork, Aalborg Universitetshospital
ClinicalTrials.gov Identifier: NCT03258983     History of Changes
Other Study ID Numbers: 17-R115-A7415-22060 - 2016-229
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christian Sørensen Bork, Aalborg Universitetshospital:
Alpha-linolenic acid
Dietary intake
Adipose tissue
Nutritional epidemiology

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Peripheral Arterial Disease
Atherosclerosis
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Peripheral Vascular Diseases