Clinical trial NCT03258983: Alpha-linolenic Acid and the Risk of ASCVD
Official title: Alpha-linolenic Acid and the Risk of Atherosclerotic Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Ischemic Stroke
Peripheral Artery Disease
Keywords: Alpha-linolenic acid
Dietary intake
Adipose tissue
Nutritional epidemiology
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Heart Foundation
First posted: 2017-08-23
Enrollment: 57053
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Diet, Cancer and Health cohort was established over a period of 3.5 years between 1993 and 1997 by inviting 160,725 men and women to participate. All eligible participants were native Danish citizens without a previous diagnosis of cancer, aged 50-64 years, and living in the areas of Copenhagen and Aarhus. A total of 57053 accepted to participate in the Diet, Cancer and Health cohort study.

A subcohort of 3500 participants were drawn randomly from the cohort at baseline.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Previous cancer

Primary outcomes:
measure: Incident acute myocardial infarction
timeFrame: From baseline until July 2013
measure: Incident ischemic stroke including total and subtypes of ischemic stroke
timeFrame: From baseline until November 2009
measure: Incident peripheral artery disease
timeFrame: From baseline until December 2009
Secondary outcomes:
measure: Incident fatal myocardial infarction
timeFrame: From baseline until July 2013
Other outcomes:
Locations:
Study officials:
affiliation: Department of Cardiology, Aalborg University Hospital, Denmark
name: Christian S Bork, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tjonneland 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. doi: 10.1080/14034940601047986.
citation: Bork CS, Veno SK, Lundbye-Christensen S, Jakobsen MU, Tjonneland A, Schmidt EB, Overvad K. Dietary Intake of alpha-Linolenic Acid Is Not Appreciably Associated with Risk of Ischemic Stroke among Middle-Aged Danish Men and Women. J Nutr. 2018 Jun 1;148(6):952-958. doi: 10.1093/jn/nxy056.