Alpha-linolenic Acid and the Risk of ASCVD
1 other identifier
observational
57,053
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 1993
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 24, 1993
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2013
CompletedFirst Submitted
Initial submission to the registry
August 19, 2017
CompletedFirst Posted
Study publicly available on registry
August 23, 2017
CompletedAugust 23, 2017
August 1, 2017
19.6 years
August 19, 2017
August 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incident acute myocardial infarction
From baseline until July 2013
Incident ischemic stroke including total and subtypes of ischemic stroke
From baseline until November 2009
Incident peripheral artery disease
From baseline until December 2009
Secondary Outcomes (1)
Incident fatal myocardial infarction
From baseline until July 2013
Study Arms (1)
The Diet, Cancer and Health cohort
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.
Eligibility Criteria
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.
You may qualify if:
- Born in Denmark
- Age between 50 and 64 years
- Living in the areas of Copenhagen and Aarhus
You may not qualify if:
- Previous cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aalborg University Hospitallead
- Danish Heart Foundationcollaborator
Related Publications (2)
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.
PMID: 17786808BACKGROUNDBork 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.
PMID: 29767732DERIVED
Biospecimen
Subcutaneous adipose tissue, serum, plasma, ''buffycoat'', erytrocytes and urine is stored in nitrogen vapour at the biobank of the Diet, Cancer and Health cohort study. Also, whole blood in filter paper and toenail clippings has been stored within the biobank.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian S Bork, MD
Department of Cardiology, Aalborg University Hospital, Denmark
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Christian Sørensen Bork
Study Record Dates
First Submitted
August 19, 2017
First Posted
August 23, 2017
Study Start
November 24, 1993
Primary Completion
July 10, 2013
Study Completion
July 10, 2013
Last Updated
August 23, 2017
Record last verified: 2017-08