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Alpha-linolenic Acid and the Risk of ASCVD

Alpha-linolenic Acid and the Risk of Atherosclerotic Cardiovascular Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03258983
Enrollment
57053
Registered
2017-08-23
Start date
1993-11-24
Completion date
2013-07-10
Last updated
2017-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, Ischemic Stroke, Peripheral Artery Disease

Keywords

Alpha-linolenic acid, Dietary intake, Adipose tissue, Nutritional epidemiology

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.

Interventions

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.

Sponsors

Danish Heart Foundation
CollaboratorOTHER
Aalborg University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

* Previous cancer

Design outcomes

Primary

MeasureTime frame
Incident acute myocardial infarctionFrom baseline until July 2013
Incident ischemic stroke including total and subtypes of ischemic strokeFrom baseline until November 2009
Incident peripheral artery diseaseFrom baseline until December 2009

Secondary

MeasureTime frame
Incident fatal myocardial infarctionFrom baseline until July 2013

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026