Alpha-linolenic Acid and the Risk of ASCVD

Completed

• Conditions: Acute Myocardial Infarction; Ischemic Stroke; Peripheral Artery Disease
• Interventions: Other: Alpha-linolenic acid

• Registration Number: NCT03258983
• Lead Sponsor: Aalborg University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1993-11-24
• Primary Completion: 2013-07-10
• Study Completion: 2013-07-10
• Status Verified: 2017-08
• Study First Submitted: 2017-08-19
• Study First Submitted QC: 2017-08-19
• Last Update Submitted: 2017-08-19
• Study First Posted: 2017-08-23
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57053

Inclusion Criteria

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

Exclusion Criteria

• Previous cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The Diet, Cancer and Health cohort	Alpha-linolenic acid	-

Primary Outcome Measures

Name	Time	Method
Incident acute myocardial infarction	From baseline until July 2013
Incident peripheral artery disease	From baseline until December 2009
Incident ischemic stroke including total and subtypes of ischemic stroke	From baseline until November 2009

Secondary Outcome Measures

Name	Time	Method
Incident fatal myocardial infarction	From baseline until July 2013