Clinical Trials Directory

Trials / Completed

CompletedNCT03258983

Alpha-linolenic Acid and the Risk of ASCVD

Alpha-linolenic Acid and the Risk of Atherosclerotic Cardiovascular Disease

Status
Completed
Phase
Study type
Observational
Enrollment
57,053 (actual)
Sponsor
Aalborg University Hospital · Academic / Other
Sex
All
Age
50 Years – 64 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
OTHERAlpha-linolenic acidExposure 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.

Timeline

Start date
1993-11-24
Primary completion
2013-07-10
Completion
2013-07-10
First posted
2017-08-23
Last updated
2017-08-23

Source: ClinicalTrials.gov record NCT03258983. Inclusion in this directory is not an endorsement.