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OpenTrials
Completed

NCT Number: NCT03258983

Alpha-linolenic Acid and the Risk of ASCVD

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.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous cancer

Treatment and study plan

Alpha-linolenic acid

Other

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 names: ALA (18:3-n3)

Primary outcomes

  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 outcomes

  1. Incident fatal myocardial infarction

    Time frame: From baseline until July 2013

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Danish Heart Foundation

Registry information

Official study title

Alpha-linolenic Acid and the Risk of Atherosclerotic Cardiovascular Disease

Important dates

Study start
1993
Primary completion
2013
Study completion
2013
First posted
Aug 23, 2017
Registry last updated
Aug 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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