Alpha-linolenic Acid and the Risk of ASCVD

Study Overview
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Brief Summary
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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.

Official Title
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Alpha-linolenic Acid and the Risk of Atherosclerotic Cardiovascular Disease

Conditions
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Acute Myocardial Infarction, Ischemic Stroke, Peripheral Artery Disease

Intervention / Treatment
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* Other: Alpha-linolenic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Born in Denmark Age between 50 and 64 years Living in the areas of Copenhagen and Aarhus Exclusion Criteria: Previous cancer

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The Diet, Cancer and Health cohort<br> | Other: Alpha-linolenic acid<br>* 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.<br>* Other names: ALA (18:3-n3);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident acute myocardial infarction |  | From baseline until July 2013 | 
| Incident ischemic stroke including total and subtypes of ischemic stroke |  | From baseline until November 2009 | 
| Incident peripheral artery disease |  | From baseline until December 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident fatal myocardial infarction |  | From baseline until July 2013 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alpha-linolenic acid, Dietary intake, Adipose tissue, Nutritional epidemiology