Alpha-linolenic Acid and the Risk of ASCVD

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Alpha-linolenic acid Other
    Other Names: ALA (18:3-n3)
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: The Diet, Cancer and Health cohort

Trial 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Incident acute myocardial infarction From baseline until July 2013
Primary Incident ischemic stroke including total and subtypes of ischemic stroke From baseline until November 2009
Primary Incident peripheral artery disease From baseline until December 2009
Secondary Incident fatal myocardial infarction 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.

Sponsors