Alpha-linolenic Acid and the Risk of ASCVD

Ischemic Stroke Clinical Trial

Official title:

Alpha-linolenic Acid and the Risk of Atherosclerotic Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03258983
• Other study ID #: 17-R115-A7415-22060 - 2016-229
• Status: Completed
• Phase: N/A
• First received: August 19, 2017
• Last updated: August 19, 2017
• Start date: November 24, 1993
• Est. completion date: July 10, 2013

Study information

• Verified date: August 2017
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57053
• Est. completion date: July 10, 2013
• Est. primary completion date: July 10, 2013
• Gender: All
• Age group: 50 Years to 64 Years

Eligibility

Inclusion Criteria:

• Born in Denmark

• Age between 50 and 64 years

• Living in the areas of Copenhagen and Aarhus

Exclusion Criteria:

• Previous cancer

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Atherosclerosis
• Infarction
• Ischemic Stroke
• Myocardial Infarction
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Other:
• Alpha-linolenic acid
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg Universitetshospital	Danish Heart Foundation

References & Publications (1)

Tjønneland A, Olsen A, Boll K, Stripp C, Christensen J, Engholm G, Overvad K. Study design, exposure variables, and socioeconomic determinants of participation in Diet, Cancer and Health: a population-based prospective cohort study of 57,053 men and women in Denmark. Scand J Public Health. 2007;35(4):432-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident acute myocardial infarction		From baseline until July 2013
Primary	Incident ischemic stroke including total and subtypes of ischemic stroke		From baseline until November 2009
Primary	Incident peripheral artery disease		From baseline until December 2009
Secondary	Incident fatal myocardial infarction		From baseline until July 2013